NAME AND DETAILS OF

MANUFACTURER:
EON MEDITECH PVT. LTD.
BL 54, 127, 129, Khanpur Road,
Mirapur, Kamrej, Surat-394320,
Gujarat, India
Tel/ Fax No.: +91-261-2494330

Email: [email protected]

Website: www. eonmeditech.com

CLINICAL
EVALUATION
PLAN

Product Name: External Nasal Splint

Document No.: EMPL/TCF/CEP/04
Issue No.: 03
Rev. No.: 01
Revision Date: 01-10-2024
Product Name: External Nasal Splint Page 1 of 132

DISCLAIMER
The Clinical Evaluation Plan is the property of EON Meditech Pvt. Ltd. No portion thereof shall be reproduced in whole or part or otherwise
disclosed without proper authorization.
Clinical Evaluation Plan of External Nasal Splint is containing the information to prove safety & performance of device manufactured by EON
Meditech Pvt. Ltd. as per the requirement of MDCG 2020-13, MEDDEV 2.7/1 Rev. 4 & EU MDR 2017/745.

We have referred the Technical File having the document number: EMPL-TCF-17-001 which was previously certified under the MDD (Medical
Devices Directive). The current Technical File is the initial version compliant with the EU MDR 2017/745.

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ABSTRACT:
Clinical evaluation plan of External Nasal Splint containing the information to prove safety & performance of device manufactured by
us as per the requirement of MDCG 2020-13, MEDDEV 2.7/1 Rev. 4 (June 2016) & annex XIV of EU MDR 2017/745.
Clinical Evaluation includes:
(As per Section “10.2. Specific considerations” of MEDDEV 2.7.1 Rev. 4; Annex XIV Clinical Evaluation & Post-Market Clinical
Evaluation and Post-Market clinical Follow-up – Part A – Clinical Evaluation of EU MDR 2017/745)
- Clearly identify the intended purpose and associated clinical benefits of the device(s) as well as the conditions of use and specific
contraindications, in a way that can be justifiably supported by the available clinical evidence
- Establish outcomes achievable with other state of the art (SOTA) therapies for the same patient populations and treatment
indications, to determine benchmarks for safety, performance and benefit-risk of the subject device
- The adequacy of clinical testing
- Confirmation that the device achieves the performance intended by manufacturer.
- Understanding the interaction between device and the body
- The comprehensiveness of available data
- The sources of data used, including use of equivalence and non-clinical evidence, if applicable
- How residual risks should be followed during PMS (uncertainties regarding medium- and long-term performance, safety under,
wide spread use, residual risk and complication occurring at rates below detection possibility of currently available clinical data,
others).
- Whether these are already being addressed in ongoing PMS activities
- Whether new or additional PMS & activities should be foreseen.

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- Draw conclusions not only regarding safety, performance and benefit-risk, but justify the completeness of the evidence to support:
o All indications (including those implied by broad intended purpose statements)
o All potential patient populations, with particular reference to high risk or vulnerable populations
o All device variants and combinations (if applicable)
o Usage with accessories and other devices (if applicable)
o Device lifetime in use
o Risk identification/confirmation of risks identified through the manufacturer’s risk management processes
o Acceptability of residual risks
THIS CLINICAL EVALUATION PLAN INCLUDES –
(As per Point no. 1 (a) of Annex XIV Clinical Evaluation & Post-Market Clinical Evaluation and Post-Market clinical Follow-up –
Part A – Clinical Evaluation of EU MDR 2017/745)
- an identification of the general safety and performance requirements that require support from relevant clinical data;
Refer Section 36.0 General Safety and Performance Requirements of this Clinical Evaluation Plan.
- a specification of the intended purpose of the device;
Refer Section 12.6 Intended Purpose of the Device and Claims of this Clinical Evaluation Plan.
- a clear specification of patient population with clear indications and contra-indications;
Refer Section 12.6 Intended Purpose of the Device and Claims of this Clinical Evaluation Plan.
- a detailed description of intended clinical benefits to patients with relevant and specified clinical outcome parameters;
Refer Section 27.0 Establishing the state-of-the-art (SOTA), similar device for safety and performance and alternative device
or treatment of this Clinical Evaluation Plan.

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- an indicative list and specification of parameters to be used to determine, based on the state of the art in medicine, the acceptability
of the benefit-risk ratio for the various indications and for the intended purpose or purposes of the device;
Refer Section 27.0 Establishing the state-of-the-art (SOTA), similar device for safety and performance and alternative device
or treatment of this Clinical Evaluation Plan for an indicative list and specification of parameters to be used to determine,
based on the state of the art in medicine
Refer Section 26.0 Risk Analysis for Potential risk associated with device as intended & evaluation of acceptability of the
benefit-risk profile of this Clinical Evaluation Plan for the acceptability of the benefit-risk ratio for the various indications
and for the intended purpose or purposes of the device)
- an indication how benefit-risk issues relating to specific components such as use of pharmaceutical, non- viable animal or human
tissues, are to be addressed; and
(This requirement is not applicable to our device as they do not contain any pharmaceutical, non- viable animal or human
tissues. Hence, we have not included this requirement in our Clinical Evaluation Plan)
- a clinical development plan indicating progression from exploratory investigations, such as first-in-man studies, feasibility and pilot
studies, to confirmatory investigations, such as pivotal clinical investigations, and a PMCF as referred to in Part B of this Annex with
an indication of milestones and a description of potential acceptance criteria;
Refer Section 24.0 Clinical Development Plan of this Clinical Evaluation Plan for justification for choosing literature route;

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1. Table of Contents
1. Table of Contents 5
2. Clinical Evaluation Plan Approval 8
3. Competence of Clinical Evaluation Team 9
4. Introduction 12
5. Importance of Clinical Evaluation 12
6. Clinical Evaluation Process 13
7. Clinical Evaluation Process Flow Chart 14
8. Interdependencies and Potential Feedback Loops Within the Clinical Evaluation Process 15
9. Terms & Definitions 15
10. Abbreviations 18
11. Objective 18
12. Scope 19
12.1 Device Description.........................................................................................................................................................................19
12.2 Administrative Particulars.............................................................................................................................................................22
12.3 Notified Body Details....................................................................................................................................................................24
12.4 Placement of Device......................................................................................................................................................................24
12.5 Status of the Device.......................................................................................................................................................................24
12.6 Number of Devices Placed on Market...........................................................................................................................................25

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13. Intended Purpose of the Device and Claims 28

14. General Device description 31
14.1. Material of Construction................................................................................................................................................................31
14.2. Sterility...........................................................................................................................................................................................31
14.3. Radioactivity..................................................................................................................................................................................31
14.4. Working principle..........................................................................................................................................................................32
14.5. How the Device Achieves its Intended Purpose............................................................................................................................32
15. Medical Alternatives to the Device 33
16. Whether it Incorporates a Medicinal Substance/Animal Tissue, or Blood Components 33
17. Whether the Device is Intended to Cover Medical Needs that are Otherwise Unmet 34
18. Whether There Are Any Design Features of the Device, or any Indications or Target Populations, That Require Specific Attention 34
19. If the Device is Equivalent to an Existing Device, with a Description of the Situation and Any New Features 34
20. Device is Intended to Enter the Market Based on Equivalence (Details of Equivalent Device) 34
21. Intended Performance 35
22. Information Provided by manufacturer 35
23. Clinical Development Plan 35
24. Justification for Non-applicability of PMCF 38
25. Demonstration of Equivalence 45
26. Risk Analysis 48
26.1 Potential Risks –............................................................................................................................................................................49
27. Establishing the State-of-the-Art (SOTA), Similar Device for Safety and Performance and Alternative Device or Treatment 55
28. Clinical Outcome Parameters 57

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29. Current Knowledge & State-of-the-Art of Device 60

30. Clinical Performance & Safety Requirements are to be verified 62
31. Data Source and Type of Data to be Used 63
32. Identification of Pertinent Data 63
32.1 Types of Data to be Used in Clinical Evaluation...........................................................................................................................64
32.2 Data Source....................................................................................................................................................................................64
33. Literature Search Strategy 90
33.1 PICO Method.................................................................................................................................................................................90
33.2 The Selection Criteria to be Applied on Published Literature.......................................................................................................95
33.3 The Data Collection Plan...............................................................................................................................................................96
34. Appraisal Plan 98
34.1 Relevance of Data/Literature Selection Process............................................................................................................................99
34.2 Appraisal Criteria for Suitability.................................................................................................................................................100
35. Level of Evidence 127
36. The Criteria to Check the Quality & Scientific Validity of Each Data 104
37. The Criteria for Determining the Relevance of Clinical Data to that of Concerned Product 105
38. Analysis of the Clinical Data 106
39. Level of Clinical Evidence (130
40. Custom Made Device 108
41. Use Under Compassionate Use/ Humanitarian Exemption Programs 108
42. Data Mapping, Conclusions & Benefit – Risk Valuation 108
43. Any New Change Introduced by the Manufacturer 109

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44. Any Specific Clinical Concerns that have Newly Emerged and Need to be Addressed) 109
45. Frequency of Update 109
46. Amendment History 110

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2. Clinical Evaluation Plan Approval

According to the provisions of MEDDEV 2.7/1 Section 6.4, the authors of this Clinical Evaluation Plan confirm that they are
suitably qualified as a team to plan the Clinical Evaluation (Stage 0) of the External Nasal Splint, to execute the evaluation (Stage 1-
3) and to finally prepare a Clinical Evaluation Report (Stage 4) appropriately and in compliance with requirements set out in
MEDDEV 2.7/1 Rev.4, MDCG 2020-13 & Annex XIV of EU MDR 2017/745. The professional qualification of the authors is
provided through CVs, Degree and their Declaration of Interests in the annexure of the Clinical Evaluation Report.
Prepared By:
Name Designation Signature Date

Mr. Nirav Khunt Director Technical 01-10-2024

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Reviewed By:
Name Designation Signature Date

Mr. Manish Donasiya Director Marketing 01-10-2024

Evaluated By:
Name Designation Signature Date

Dr. Bhavin H. Patel Consultant ENT Surgeon 01-10-2024

3. Competence of Clinical Evaluation Team

(As per section 6.4 “who should perform the clinical evaluation plan?” of MEDDEV 2.7/1 Rev.4)
We have considered the below mentioned knowledge and experience for selecting our Clinical Evaluation Team –
- How the medical device is constructed
- How the medical device works
- How the medical device is produced
- How the medical device is actually used
- How to conduct clinical evaluation activity

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We have also provided their CV and Declaration of Interests as the documented evidence of their competence and skills. We have
also provided the required training material of the training the members of Clinical Evaluation Team were trained for.
Responsible persons for activities
Evaluator of Clinical Evaluation Plan
1. Name Dr. Bhavin Harshadbhai Patel
2. Qualification MS (ENT). DLO
3. Required Awareness - Clinical Evaluation Guideline – MEDDEV 2.7/1 Rev. 4
- MDCG 2020-13 – Clinical Evaluation Assessment Report Template
- MDCG 2020-5 – Clinical Evaluation – Equivalence A guide for manufacturers and
notified bodies
- Quality Management System of Medical Device as per ISO 13485:2016

4. Required Skills - Knowledge of the EU MDR 2017/745 and Risk Management Standard – EN ISO
14971:2019/A11:2021
- Product knowledge and its application knowledge
- Good exposure on regulatory requirements
- Knowledge of the website searching for the literature data from search engines like
Google Scholar, PubMed and other related website of medical device technology and its
application.
- Knowledge of the analysis of all the literature and their appraisal

5. Experience >24 Years

6. Reference documents CV, Degree & Declaration of Interest

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Refer Annex 6 > 6.4 Clinical Evaluation > 6.4.2 Clinical Evaluation Team of the TCF
of External Nasal splint

Reviewer of Clinical Evaluation Plan

1. Name Mr. Sandip Savaliya
2. Qualification B.E. Mechanical
3. Required Awareness - Clinical Evaluation Guideline – MEDDEV 2.7/1 Rev. 4
- MDCG 2020-13 – Clinical Evaluation Assessment Report Template
- MDCG 2020-5 – Clinical Evaluation – Equivalence A guide for manufacturers and
notified bodies
- Quality Management System of Medical Device as per ISO 13485:2016

4. Required Skills - Knowledge of the EU MDR 2017/745 and Risk Management Standard – EN ISO
14971:2019/A11:2021
- Product knowledge and its application knowledge
- Good exposure on regulatory requirements
- Knowledge of the website searching for the literature data from search engines like
Google Scholar, PubMed and other related website of medical device technology and its
application.
- Knowledge of the analysis of all the literature and their appraisal

5. Experience >10 years

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6. Reference documents CV, Degree & Declaration of Interest

Refer Annex 6 > 6.4 Clinical Evaluation > 6.4.2 Clinical Evaluation Team of the TCF
of External Nasal splint

Author of Clinical Evaluation Plan

1. Name Mr. Nirav Khunt
2. Qualification B.Tech (Mechanical)
3. Required Awareness - Clinical Evaluation Guideline – MEDDEV 2.7/1 Rev. 4
- MDCG 2020-13 – Clinical Evaluation Assessment Report Template
- MDCG 2020-5 – Clinical Evaluation – Equivalence A guide for manufacturers and
notified bodies
- Quality Management System of Medical Device as per ISO 13485:2016

4. Required Skills - Knowledge of the Medical Device Regulation EU MDR 2017/745 and Risk Management
Standard – EN ISO 14971:2019/A11:2021
- Product knowledge and its application knowledge
- Good exposure on regulatory requirements
- Knowledge of the website searching for the literature data from search engines like
Google Scholar, PubMed and other related website of medical device technology and its
application.
- Knowledge of the analysis of all the literature and their appraisal

5. Experience >7 Years

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6. Reference documents CV, Degree & Declaration of Interest

Refer Annex 6 > 6.4 Clinical Evaluation > 6.4.2 Clinical Evaluation Team of the TCF
of External Nasal splint

4. Introduction
(As per section 6.1 “What is clinical evaluation?” of MEDDEV 2.7/1 Rev.4)
Clinical Evaluation is a methodologically sound ongoing procedure to collect, appraise and analyze clinical data pertaining to a
medical device and to analyze whether there is sufficient clinical evidence to confirm compliance with relevant General Safety &
Performance Requirements (GSPRs) for safety and performance (in accordance with Annex I EU MDR 2017/745) when using the
device according to the manufacturer’s instructions for use.
This document concerns the overall clinical evaluation planning of “External Nasal Splint”.
5. Importance of Clinical Evaluation
(As per section 6.2 “When is clinical evaluation undertaken and why is it important?” of MEDDEV 2.7/1 Rev.4)
Clinical Evaluation is conducted throughout the life cycle of a medical device, as an ongoing process. It is performed during the
development of the device in order to identify data that need to be generated for regulatory purposes and will inform if a new device
clinical investigation is necessary, together with the outcomes which need to be studied. It is then repeated periodically as new
safety, clinical performance and/or effectiveness information about the medical device is obtained during its use. This information is
fed into the ongoing risk management process (according EN ISO 14971:2019/A11:2021) and may result in changes to the
manufacturer's risk assessment, Instructions for Use and post market activities.
Clinical Evaluation is necessary and mandatory to ensure that device achieves the intended purpose including the promised clinical
performance and safety.

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6. Clinical Evaluation Stages

(As per section 6.3 “How is a clinical evaluation performed?” of MEDDEV 2.7/1 Rev.4)
The clinical evaluation is based on a comprehensive analysis of available pre- and post-market clinical data relevant to the intended
purpose of the device in question, including clinical performance data and clinical safety data.
There are discrete stages in performing a clinical evaluation:

Figure 1. -Clinical evaluation stages

7. Clinical Evaluation Process Flow Chart

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Figure 2.-Clinical evaluation process flowchart

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8. Interdependencies and Potential Feedback Loops Within the Clinical Evaluation Process

Figure 3.- Interdependencies and potential feedback loops within the clinical evaluation process
9. Guideline and Regulations
Sr. Standard Title
No.

Harmonized standards

1. EN ISO 14971:2019/A11:2021 Medical devices – Application of risk

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Product Name: External Nasal Splint Page 18 of 132

Sr. Standard Title

No.

management to medical devices (ISO

14971:2019)

2. EN ISO 15223-1:2021 Medical devices - Symbols to be used with

information to be supplied by the
manufacturer - Part 1: General requirements
(ISO 15223-1:2021)

3. EN ISO 11135:2014/A1:2019 Sterilization of health-care products —

Ethylene oxide — Requirements for the
development, validation and routine control
of a sterilization process for medical devices

4. EN ISO 11737 1:2018/A1:2021 Sterilization of health care products —

Microbiological methods — Part 1:
Determination of a population of
microorganisms on products

5. EN ISO 11737-2:2020 Sterilization of health care products —

Microbiological methods — Part 2: Tests of
sterility performed in the definition,
validation and maintenance of a sterilization
process

6. EN ISO 11607-1:2020 Packaging for terminally sterilized medical

devices — Part 1: Requirements for
materials, sterile barrier systems and

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Sr. Standard Title

No.

packaging systems

7. EN ISO 11607-2:2020 Packaging for terminally sterilized medical

devices — Part 2: Validation requirements
for forming, sealing and assembly processes

Non-harmonized standards

8. ISO 13485:2016 Medical devices - Quality management

systems - Requirements for regulatory
purposes

9. ISO 9001:2015 Quality management systems —

Requirements

10. ISO 20417:2021 Medical devices-Information supplied by

the manufacturer of medical devices

11. ISO 10993-1:2018 Biological Evaluation of medical devices-

Part:1 Evaluation and testing within a risk
management process

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Sr. Standard Title

No.

12. ISO 14644-1:2015 Cleanrooms and associated controlled

environments — Part 1: Classification of air
cleanliness by particle concentration

13. ISO 14644-2:2015 Cleanrooms and associated controlled

environments — Part 2: Monitoring to
provide evidence of cleanroom performance
related to air cleanliness by particle
concentration

14. ISO 14644-3:2019 Cleanrooms and associated controlled

environments — Part 3: Test methods

15. ISO 11138-1:2017 Sterilization of health care products —

Biological indicators — Part 1: General
Requirements

16. ISO 11138-2:2017 Sterilization of health care products —

Biological indicators — Part 2: Biological
indicators for ethylene oxide sterilization
processes

17. ISO 10993-7:2008/AMD 1:2019 Biological evaluation of medical devices —

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Sr. Standard Title

No.

Part 7: Ethylene oxide sterilization residuals

18. ISO 3166-1:2020 Codes for the representation of names of

countries and their subdivisions — Part 1:
Country code

19. ASTM F 1980-21 Standard Guide for Accelerated Aging of

Sterile Barrier Systems for Medical Devices

20. IEC 62366-1:2015/AMD 1:2020 Medical devices — Part 1: Application of

usability engineering to medical devices

Directives & Guidance Documents

21. MEDDEV 2.7/1 revision 4 Clinical Evaluation: A Guide for

Manufacturers and Notified Bodies Under
Directives 93/42/EEC And 90/385/EEC

22. MEDDEV 2.12/1 revision 8 Guidelines on a medical devices vigilance

system

23. MEDDEV 2.12/2 revision 2 Guidance document medical devices -

Market surveillance - Post Market Clinical
Follow-up studies

24. MDCG-2020-5 Clinical Evaluation – Equivalence A guide

for manufacturers and notified bodies

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Sr. Standard Title

No.

25. MDCG 2021-24 Guidance on classification of medical

devices

26. MDCG 2021-25 Application of MDR requirements to

‘legacy devices’ and to devices placed on
the market prior to 26 May 2021 in
accordance with Directives 90/385/EEC or
93

27. MDCG-2020-6 Regulation (EU) 2017/745: Clinical

evidence needed for medical devices
previously CE marked under Directives
93/42/EEC or 90/385/EEC A guide for
manufacturers and notified bodies

28. MDCG-2020-13 Clinical evaluation assessment report

template

29. ISO/TR 24971:2020 Medical devices — Guidance on the

application of ISO 14971

30. NB-MED-2_12-1_rev11 Post-Marketing Surveillance (PMS) post

market/production

31. ISO/TR 20416:2020 Medical devices — Post - Market

Surveillance for manufacturers

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Sr. Standard Title

No.

32. MDCG 2023-3 Questions and Answers on vigilance terms

and concepts as outlined in the Regulation
(EU) 2017/745 on medical devices

33. IEC TR 62366-2:2016 Medical devices - Part 2: Guidance on the

application of usability engineering to
medical devices

10. Terms & Definitions

(As per Section “4. Definitions” of MEDDEV 2.7.1 Rev. 4)
● Adverse Events - any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs (including an
abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
● Clinical data - the safety and/or performance information that is generated from the clinical use of a device. Clinical data are
sourced from:
- Clinical investigation(s) of the device concerned; or
- Clinical investigation(s) or other studies reported in the scientific literature, of a similar device for; which equivalence to the
device in question can be demonstrated; or
- Published and/or unpublished reports on other clinical experience of either the device in question or a similar device for
which equivalence to the device in question can be demonstrated.

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● Clinical evaluation - a methodologically sound ongoing procedure to collect, appraise and analyze clinical data pertaining to a
medical device and to evaluate whether there is sufficient clinical evidence to confirm compliance with relevant essential
requirements for safety and performance when using the device according to the manufacturer’s Instructions for Use.
● Clinical evidence - the clinical data and the clinical evaluation report pertaining to a medical device.
● Clinical performance - behaviour of a medical device or response of the subject(s) to that medical device in relation to its
intended use, when correctly applied to appropriate subject(s).
● Clinical safety - freedom from unacceptable clinical risks, when using the device according to the manufacturer’s Instructions
for Use.
● Clinical use - use of a medical device in or on living human subjects.
● Equivalent device - a device for which equivalence to the device in question can be demonstrated.
● Hazard - potential source of harm.
● Hazard due to substances and technologies - for the purpose of MEDDEV 2.7.1 Rev. 4, a hazard that is seen with products
that share specific characteristics.
- Note: This includes products that contain the same materials and substances, material combinations, use the same
technologies, produce similar abrasion, are used with the same type of surgical approach, share the same manufacturing
procedures or impurities, or share other characteristics.
● Incident - any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in
the labelling or the instructions for use which, directly or indirectly, might lead to or might have led to the death of a patient, or
user or of other persons or to a serious deterioration in their state of health.
● Information materials supplied by the manufacturer - for the purpose of this document, this refers to the labelling,
instructions for use and the manufacturer's promotional materials for the device under evaluation.

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● Intended purpose - the use for which the device is intended according to the data supplied by the manufacturer on the labelling,
in the instructions and/or in promotional materials.
● Risk: combination of the probability of occurrence of harm and the severity of that harm.
● Risk management: systematic application of management policies, procedures and practices to the tasks of analyzing,
evaluating, controlling and monitoring risk.
● Serious adverse event: adverse event that
- led to death,
- led to serious deterioration in the health of the subject, that either resulted in
o a life-threatening illness or injury, or
o a permanent impairment of a body structure or a body function, or
o in-patient or prolonged hospitalization, or
o medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body
structure or a body function,
- led to foetal distress, foetal death or a congenital abnormality or birth defect.
11. Abbreviations
(As per Section “5. Abbreviations” of MEDDEV 2.7.1 Rev. 4)
- CEP – Clinical Evaluation Plan
- CER - Clinical Evaluation Report
- EUDAMED- European databank on medical devices
- GSPR – General Safety & Performance Requirements
- IFU - Instructions for Use

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- EU MDR – European Medical Device Regulation EU MDR 2017/745

- PMS - Post Market Surveillance
- PMSR- Post Market Surveillance Report
- PMCF- Post-Market Clinical Follow-up
- DOE – Demonstration of Equivalence
- LSP – Literature search Protocol
- LSR – Literature search Report
- SRN- Single Registration Number
12. Objective
(As per Section 7 “Definition of the scope of the clinical evaluation (Stage 0)” of MEDDEV 2.7/1 Rev.4)
The objective of Clinical Evaluation Plan is to define the scope of the Clinical evaluation based on the General Safety &
Performance Requirements that need to be addressed from a clinical perspective, the nature and history of the device, that aids to
confirm clinical performance and safety throughout the expected lifetime of the “External Nasal Splint” which is manufactured by
EON Meditech Pvt. Ltd. the acceptability of identified risks and to detect emerging risks on the basis of factual evidence.
The plan is intended to methodologically present all the information/data and methods/stages that can be used during the clinical
evaluation of the concerned product. The core objective of this plan is to outline the clinical evaluation, which shall be basically
carried out for proving the safety and effectiveness of the concerned product for real life patients. The Risk Analysis and its reports
shall be considered during the evaluation and same shall be indicated in the conclusion of Clinical Evaluation Report. The benefit-
risk profile of the device has been analysed as per medical indications and we accept that the profile is based on the state of art in the
fields concerned.

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13. Scope
(As per Section 7 “Definition of the scope of the clinical evaluation (Stage 0)” & Appendix A3 “Device description-typical
contents” of MEDDEV 2.7/1 Rev.4)
13.1 Device Description
Device Name External Nasal Splint
Brand Name Osseous, Orleon, Salient, Medinique, ENTech
Size/Variants Refer Annex 1> 1.2 Product List of TCF
Device Group Rhinology Products

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Sr. Name and manufacturer of similar device

No. (External Aluminium Nasal Splint)
1. Denver Aluminium Splint manufactured by Summit
Medical
2. External Aluminium Nasal Splint manufactured by
Invotec International Inc.
3. External Aluminium Nasal Splint manufactured by
NETWORK MEDICAL PRODUCTS
Details of Similar device Name and manufacturer of similar device (External
Thermoplastic Nasal Splint)
1. Denver Thermoplastic Splint manufactured by
Summit Medical
2. External Thermoplastic Nasal Splint manufactured by
Invotec International Inc.
3. External Thermoplastic Nasal Splint manufactured by
NETWORK MEDICAL PRODUCTS

Refer Annex 1> 1.4 Similar Device Report

Common specifications, harmonized Refer Annex 4. LOAS and GSPR > 4.1 LOAS
standards or other solutions applied
Refer Section 9 Guidelines and Regulations of this CEP

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Basic UDI-DI 89044287ENS4S

35411-External Nasal Splint

A rigid or semi-rigid device intended to be applied externally to the nose for
GMDN code the immobilization of nasal bones and cartilage, typically after a fracture or
surgery. It functions as a truss-like support on the outside of the nose. This is
a single-use device.
EMDN Code Q0399 – ENT OTHERS
MDN 1214
MDS 1005
MDT 2001
MDR codes
MDT 2002
MDT 2008
MDT 2011
Class Is, Rule 1
Risk Class of Device
Refer Annex 1> 1.3 classification report EMPL/TCF/CR/04
EU MDR 2017/745:
Description of conformity Chapter I & III of Annex IX> Annex IX Chapter II
assessment procedure Annex II and III Technical Documentation> EU Declaration of Conformity
Annex IV> CE Marking Annex V
Table 1. – Device Description

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Difference between two variants

Device
External Aluminum Nasal Splint External Thermoplastic Nasal Splint
Name
An external Nasal Splint is used for splinting of
An external Nasal Splint is used for
the nasal dorsum after a nasal surgical
splinting of the nasal dorsum after a nasal
Intended procedure. It protects the nose from external
surgical procedure. It protects the nose from
Purpose trauma and prevents the dislocation of nasal
external trauma and prevents the dislocation
bones.
of nasal bones.

Raw Aluminum (AA1050) Thermoplastic (99% Polycaprolactone)

material IPXE foam IPXE foam

Self-adhesive tape Self-adhesive tape

EON Meditech Pvt. Ltd. manufactures EON Meditech Pvt. Ltd. manufactures External
External Nasal Splints using aluminum as Nasal Splints using Thermoplastic as the raw
the raw material. These splints do not come material. These splints do not come into direct
into direct contact with the patient, as they contact with the patient, as they are applied
are applied using self-adhesive tape. using self-adhesive tape. Consequently,
Consequently, biocompatibility tests have biocompatibility tests have not been conducted.
not been conducted.
We have conducted testing of the aluminum raw
We have conducted testing of the aluminum material at an external testing laboratory. The

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Difference between two variants

Device
External Aluminum Nasal Splint External Thermoplastic Nasal Splint
Name
raw material at an external testing results indicate that the material meets all the
laboratory. The results indicate that the specified limits and requirements.
material meets all the specified limits and
Refer - Annex 6 > 6.1 Pre- Clinical Testing >
requirements. 6.1.1 Biocompatibility Testing

Refer - Annex 6 > 6.1 Pre- Clinical Annex 3> 3.6 RM PM & FP specifications>
Testing > 6.1.1 Biocompatibility Testing 3.6.2 Test Reports- RM

Annex 3> 3.6 RM PM & FP

specifications> 3.6.2 Test Reports- RM

Sizes Small, Medium, Large Small, Medium, Large

Handling 1. Check the device and its packaging for 1. Check the device and its packaging for its
of the its damage. If the product or its damage. If the product or its packaging is
device packaging is damaged, Do Not use the damaged, Do Not use the device.
device. 2. Responsibility of proper selection of
2. Responsibility of proper selection of External nasal splints as per patient need,
External nasal splints as per patient rests with the Surgeon.
need, rests with the Surgeon.

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Difference between two variants

Device
External Aluminum Nasal Splint External Thermoplastic Nasal Splint
Name
3. Cleanse and dry skin of the nose. 3. Cleanse and dry skin of the nose.
4. Use an alcohol Swab to wipe your nose. 4. Use an alcohol Swab to wipe your nose. Dry
Dry skin of nose after wiping. skin of nose after wiping.
5. Express edema manually from the skin. 5. Express edema manually from the skin.
6. Express edema again. 6. Express edema again.
7. Apply skin preparation pad 7. Apply skin preparation pad
8. Apply overlapping paper tape to nose- 8. Apply overlapping paper tape to nose-Apply
Apply ½ inch wide skin closure tape ½ inch wide skin closure tape starting at the
starting at the bottom of the nose being bottom of the nose being careful to overlap
careful to overlap each strip to be each strip to be assured that all the skin in
assured that all the skin in application application area is covered.
area is covered. 9. Select the size of splint as per requirement
9. Select the size of splint as per 10.Trim dorsal pad length to fit splint size.
requirement Apply center dorsal pad vertically to tape on
10.Trim dorsal pad length to fit splint size. the dorsum of the nose. Do not touch skin
Apply center dorsal pad vertically to with dorsal pad.
tape on the dorsum of the nose. Do not 11.Soften the splint in 160-180°F (71-82°C)
touch skin with dorsal pad. Sterile water for injection 30 to 60 seconds

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Difference between two variants

Device
External Aluminum Nasal Splint External Thermoplastic Nasal Splint
Name
until the splint will turn transparent. Remove
the splint from water using forceps or a
tongue depressor to avoid burning fingers.
11.Remove paper backing from adhesive 12.Apply a softened splint and mold over the
side of splint. nose.
12.Shape metal. Apply adhesive side of 13.Apply cold water slowly over the molded
splint to tape on the nose. Do not pinch. splint until the splint gains its original color.
When in place, the splint should touch only
the underlying tape and should not touch the
skin.
Table 2. – Difference between variants
13.2 Administrative Particulars
(As per section A “Administrative particulars” of MDCG 2020-13)
Manufacturer Details
Name of the Manufacturer EON Meditech Pvt. Ltd.
BL 54, 127, 129, Khanpur Road, Mirapur, Kamrej, Surat-394320, Gujarat,
Address of the Manufacturer
India
Contact Details Tel/ Fax No.: +91-261-2494330

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Email: [email protected]
Website: www. eonmeditech.com

Registered Trademark

SRN IN-MF-000014457
Authorized Representative Details
Name of the Authorized
CMC Medical Devices & Drugs S. L
Representative
C/Horacio Lengo N° 18, CP 29006, Malaga, Spain
Address of the Authorized
Tel: +34 951 214 054
Representative
Email: [email protected]
SRN ES-AR-000000293
Table 3. – Administrative Particulars

13.3 Notified Body Details

(As per Section A: Administrative particulars (notified body, manufacturer, product and clinical evaluation report
reference) of MDCG 2020-13
Name of Notified Body Deutsch Quality Systems (India) Private Limited
Address of the Notified Body Ground Floor, South Wing, Vaishnavi Tech
Park, Sy No 16/1 and 17/2, Bellandur Gate,

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Sarjapur Main Road, Ambalipura, Bengaluru-

560102
Phone: (080) 6661-6518 / +91 9243203043
Fax: +91 80 6661 6530
Contact Details of the Notified Body
Email: [email protected]
Website: www.dqsglobal.com
Notified Body Number 0297
Table 4. – Notified body Details
13.4 Placement of Device
(As per Appendix A3 “Device description-typical contents” of MEDDEV 2.7/1 Rev.4)
The concerned product is based on long-standing, well-established technology. No changes in product design or manufacturing
processes have been reported till date.
13.5 Status of the Device
(As per “A3. Device description - typical contents” of MEDDEV 2.7.1 Rev. 4)
EON Meditech Pvt. Ltd. does not have any previous generation of device. External Nasal Splint were marketed for sale from
January 2017 and no change was identified through out these years. The device is MDD certified in October 2018
(Certificate for Is: ECM18MDD016) and for the devices certified under MDD, the semifinished components were purchased
from suppliers, but currently we shall be manufacturing the device in house from raw materials and Blister packing process
for primary packing shall be introduced.
We are now applying for the CE certification for the External Nasal Splint under the EU MDR 2017/745.

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13.6 Number of Devices Placed on Market

Sr. No. Year Product Name Total No of Products Sold
1. 2017-18 1236
2. 2018-19 754
3. 2019-20 814
4. 2020-21 1293
External Aluminum Splints
5. 2021-22 2310
Small
6. 2022-23 2245
7. 2023-24 4045
2024 -June
8. 3036
2024
Table 5. – External Aluminum Splints Small

Sr.
Year Product Name Total No of Products Sold
No.
1. 2017-18 External Aluminum Splints 5816
2. 2018-19 Medium 7205
3. 2019-20 12233
4. 2020-21 7696
5. 2021-22 7728
6. 2022-23 9796

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Sr.
Year Product Name Total No of Products Sold
No.
7. 2023-24 10280
2024 -June
8. 4490
2024

Table 6. – External Aluminum Splints Medium

Sr.
Year Product Name Total No of Products Sold
No.
1. 2017-18 3551
2. 2018-19 5877
3. 2019-20 7040
4. 2020-21 3777
External Aluminum Splints
5. 2021-22 5975
Large
6. 2022-23 4550
7. 2023-24 5174
2024 -June
8. 3951
2024
Table 7. – External Aluminum Splints Large

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Sr.
Year Product Name Total No of Products Sold
No.
1. 2017-18 636
2. 2018-19 227
3. 2019-20 1947
4. 2020-21 902
External Thermoplastic Splints
5. 2021-22 1280
Small
6. 2022-23 1250
7. 2023-24 686
2024 -June
8. 1436
2024
Table 8. – External Thermoplastic Splints Small

Sr.
Year Product Name Total No of Products Sold
No.
1. 2017-18 External Thermoplastic Splints 3382
2. 2018-19 Medium 7677
3. 2019-20 10692
4. 2020-21 6294
5. 2021-22 12514
6. 2022-23 8632
7. 2023-24 6637

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Sr.
Year Product Name Total No of Products Sold
No.

2024 -June
8. 13034
2024
Table 9. – External Thermoplastic Splints Medium

Sr.
Year Product Name Total No of Products Sold
No.
1. 2017-18 1424
2. 2018-19 555
3. 2019-20 5595
4. 2020-21 2573
External Thermoplastic Splints
5. 2021-22 3495
Large
6. 2022-23 5181
7. 2023-24 1759
2024 -June
8. 541
2024
Table 10. – External Thermoplastic Splints Large
14. Intended Purpose of the Device and Claims
(As per “A3. Device description - typical contents” of MEDDEV 2.7.1 Rev. 4)
Product Name External Nasal Splint

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An external Nasal Splint is used for splinting of the nasal dorsum after a nasal surgical
Intended Purpose procedure. It protects the nose from external trauma and prevents the dislocation of nasal
bones.

External Aluminum Splint Aluminum Splint Kit

Device Images

External Thermoplastic Splint

Thermoplastic Splint Kit

Indications 1 Septoplasty

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2 Rhinoplasty
3 Septorhinoplasty
4 Nasal Fracture
The External nasal splint can be used by, health professionals, for example, by
Intended User
otorhinolaryngology (ENT).
Patient population: External nasal splints can be used on all patient populations.
Point of Contact The device does not have direct or indirect contact with the body.
Duration of Contact Short-term use (Maximum 30 days)
NA. As our device is for single use. Reuse of the device could result in infection,
Repeated Application
contamination and device failure which could lead to patient harm.
Invasiveness/Mucosal
Non-invasive
Contact
Use Environment The device is intended to be used in healthcare settings only.
Do not use in known cases of severe soft tissue injuries that compromise the blood supply to
Contraindications
the skin.
1 Remove the splint prior to X-ray, CT, or MRI imaging. Splints may interfere with image
quality.
Precautions
2 Do not apply the splint directly to the skin- may cause mild sensitization in certain
sensitive individuals. Apply paper tape first.
Warnings 1 For Single Use Only. Do not reuse. Reuse of the device could result in infection and
contamination device failure which could lead to patient harm.

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2 Do not re-sterilize.
3 Do not use if the package is damaged or unintentionally opened prior to use, or if the
dorsal pad is compressed.
1 Minor Scar Tissue
Possible side effects 2 Localized Infection
3 Minor discomfort
Limitations: An external Nasal Splint must be used with self-adhesive tape. If self-adhesive tape is not
used, the device will not properly adhere to the target site
Clinical Benefits: Healing Bone fracture
Performance 1 Provides Compression to the nose
characteristics: 2 Reduce edema
3 Stabilization of Nasal framework
Shelf Life of the device External nasal splint has a maximum expected lifetime of 3 years
Sterile Device (Yes/No) Yes
Type of Sterilization Ethylene oxide (ETO) sterilization method.
Re-sterilization NA. As our device is single use device, there is no requirement of resterilization.
The device shall be stored from 5℃ to 55℃ temperature & in an unopened original package.
Storage condition Each External Nasal Splint bears a batch number and an expiry date and may not be used
after that date. The device shall be stored away from sunlight and in dry place (60±10 % RH)
Disposal Discard the device in an appropriate waste-container & dispose of the product in accordance
with accepted medical practice and applicable local, state and national laws and regulations
for handling of bio-medical waste. If unused, product in original packaging which has

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exceeded the declared shelf life should be removed from packaging and disposed of as
clinical waste.
● EON Meditech Pvt. Ltd. does not have any previous generation of device. External
Nasal Splint were marketed for sale from January 2017 and no change was identified
through out these years. The device is MDD certified in October 2018 (Certificate for
Is: ECM18MDD016) and for the devices certified under MDD, the semifinished
components were purchased from suppliers, but currently we shall be manufacturing the
device in house from raw materials and Blister packing process for primary packing
shall be introduced.
Reference to previous ● We are now applying for the CE certification for the External Nasal Splint under the
and similar generations EU MDR 2017/745.
of the device ● Market History is documented in PMS report. Refer Annex 7>PMSR
(EMPL/TCF/PMSR/04)
● There are similar devices which are available in European Market and International
Market. Similar device which is available in European Market are Denver Nasal Splint®
manufactured by Summit Medical, SOFT-FORM™ Thermoplastic nasal splint and
SOFT-FORM AL-B™ Aluminum nasal splint manufactured by Invotec and External
nasal splint: Malleable &External Nasal Splint: Thermoplastic manufactured by
NETWORK Medical.
Novel features The product does not have any novel features.

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Accessories & The product does not have any accessories for device. The device is not used in combination
Combination with other device or other products which are not device.
Table 11. – Intended Purpose of the Device and Claims
15. General Device description
(As per Appendix A3 “Device description-typical contents” of MEDDEV 2.7/1 Rev.4)
14.1. Material of Construction
Refer Annex 3 > 3.7 RM PM & FP specifications > 3.7.2 Raw Material Test Reports of the TCF
Aluminium (AA1050)
External Nasal Splint (Aluminium) IPXE foam
Self-adhesive tape
Thermoplastic (99% Polycaprolactone)
External Nasal Splint (Thermoplastic) Self-adhesive tape
IPXE foam
Table 12. – Material of Construction
● This product category does not contain animal tissue or blood products. The product does not emit any radioactive radiation.
Refer Annex 6 > 6.6. Declaration of Animal Origin, Human Origin, Drug of the TCF
14.2. Sterility
(As per “A3. Device description - typical contents” of MEDDEV 2.7.1 Rev. 4)
The product is supplied in sterile condition. External Nasal Splint are sterilized by using Ethylene Oxide sterilization method.
Sterilization process is done as per parameters validated in sterilization validation.
Refer Annex 3 > 3.3 Process Validations > 3.3.3 Sterilization Validation in of the TCF

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14.3. Radioactivity
(As per “A3. Device description - typical contents” of MEDDEV 2.7.1 Rev. 4)
The product does not emit any radioactive radiation.
14.4. Working principle
(As per “A3. Device description - typical contents” of MEDDEV 2.7.1 Rev. 4)
The External Nasal Splint is applied on nasal dorsal septum to envelope the underlying nasal framework, which is particularly
important after rhinoplasty that involves freeing the nasal soft tissues from the underlying bony and cartilaginous frame.
External Nasal Splint include two: metal splints or thermoplastic splints to help keep the nose in shape following the
application of an adhesive tape. Adhesive tape helps in proper holding of broken bones of the nose and the cartilages (compress
the cartilage) & keep the reformed nose and its lower bone fixed during recovery. This action leads to maintaining the
corrected anatomy in the intended position with appropriate stabilization and immobilization.
14.5. How the Device Achieves its Intended Purpose
(As per “A3. Device description - typical contents” of MEDDEV 2.7.1 Rev. 4)
Device Handling
General
1. Check the device and its packaging for its damage. If the product or its packaging is damaged, Do Not use the device.
2. Responsibility of proper selection of External nasal splints as per patient need, rests with the Surgeon.
3. Cleanse and dry skin of the nose.
4. Use an alcohol Swab to wipe your nose. Dry skin of nose after wiping.
5. Express edema manually from the skin.
6. Express edema again.
7. Apply skin preparation pad

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8. Apply overlapping paper tape to nose-Apply ½ inch wide skin closure tape starting at the bottom of the nose being
careful to overlap each strip to be assured that all the skin in application area is covered.
Aluminum External Nasal Splint
9. Select the size of splint as per requirement
10. Trim dorsal pad length to fit splint size. Apply center dorsal pad vertically to tape on the dorsum of the nose. DO NOT
TOUCH SKIN WITH DORSAL PAD.
11. Remove paper backing from adhesive side of splint.
12. Shape metal. Apply adhesive side of splint to tape on the nose. DO NOT PINCH.
Thermoplastic External Nasal Splint
9. Select the size of splint as per requirement
10. Trim dorsal pad length to fit splint size. Apply center dorsal pad vertically to tape on the dorsum of the nose. DO NOT
TOUCH SKIN WITH DORSAL PAD.
11. Soften the splint in 160-180°F (71-82°C) Sterile water for injection 30 to 60 seconds until the splint will turn
transparent. Remove the splint from water using forceps or a tongue depressor to avoid burning fingers.
12. Apply a softened splint and mould over the nose.
13. Apply cold water slowly over the moulded splint until the splint gains its original color.
14. When in place, the splint should touch only the underlying tape and should not touch the skin.
16. Medical Alternatives to the Device
(As per “A3. Device description - typical contents” of MEDDEV 2.7.1 Rev. 4)
- Steri-strip technique
Analysis of this will be done in literature appraisal and evidences will be recorded in clinical evaluation report.
Refer Annex 6 > 6.4 Clinical Evaluation > 6.4.6. Clinical Evaluation Report

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17. Whether it Incorporates a Medicinal Substance/Animal Tissue, or Blood Components

Device does not incorporate any medicinal substance, animal tissue or human blood components.
Refer Annex 6 > 6.6 Declarations of the TCF of External Nasal Splint
18. Whether the Device is Intended to Cover Medical Needs that are Otherwise Unmet
Not Applicable. The device is not an innovative product or standalone product. And the device has the proper intended purpose.
19. Whether There Are Any Design Features of the Device, or any Indications or Target Populations, That Require Specific
Attention
Not Applicable
20. If the Device is Equivalent to an Existing Device, with a Description of the Situation and Any New Features
The concerned devices are presumed to be equivalent to External Nasal Splint manufactured by SPIGGLE & THEIS. These
products manufactured by above mentioned manufacturer’s possess similar design features and are used under same clinical
conditions.
No new features are identified in the equivalent device.
CE mark status: CE certified under EU MDD 93/42/EEC, validity 08-04-2024
CE Certificate number: 170656945
21. Device is Intended to Enter the Market Based on Equivalence (Details of Equivalent Device)
The device is intended to enter the market based on equivalence. The concerned devices are presumed to be equivalent to devices
manufactured by SPIGGLE & THEIS. The exact equivalence with device features will be detailed in the Clinical Evaluation
Report.
Refer Annex 6 > 6.4 Clinical Evaluation > 6.4.4 Equivalent Device Content of the TCF of External Nasal Splint
22. Intended Performance
Intended Performance will be identified through literature appraisal and added in the Clinical evaluation report.

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Refer Annex 6 > 6.4 Clinical Evaluation > 6.4.6. Clinical Evaluation Report
23. Information Provided by manufacturer
- Primary Label
Document No: EMPL/TCF/PL/04, Issue: 03, Rev. No: 000, Date: 25.07.2024
- Secondary Label
Document No: EMPL/TCF/SL/04, Issue: 03, Rev. No: 000, Date: 25.07.2024
- Shipper Label:
Document No: EMPL/TCF/SHL/04, Issue: 03, Rev. No: 000, Date: 25.07.2024
Refer Annex 2 > 2.3 Label of the TCF of External Nasal Splint
- IFU
Document No: EMPL/TCF/IFU/04, Issue: 03, Rev. No: 00, Revision Date: 25.07.2024
Refer Annex 2 > 2.2 Instruction for Use (IFU) of the TCF of External Nasal Splint
24. Clinical Development Plan
Clinical development plan indicates progression from exploratory investigations, such as first-in-man studies, feasibility and pilot
studies, to confirmatory investigations, such as pivotal clinical investigations, and a PMCF as referred to in Part B of Annex XIV
with an indication of milestones and a description of potential acceptance criteria.
Below we have laid down a plan which indicates how the devices were developed: -
1. We had obtained samples of similar devices form market from companies like Summit Medical, Invotec International Inc.,
NETWORK MEDICAL PRODUCTS, and many others which are available on the EU market as well, and we have
reviewed the samples for its specifications like size, material specifications and tested the same.
2. We have also referred many standards from ISO, ASTM for the External Nasal Splint and developed specifications to design
the devices.

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3. Design and development activities were undertaken to develop the product. The records of design and development are
maintained in form of design file which consists of following documents:
- Design and development planning
- Design and development input
- Design and development input review
- Design and development output
- Design and development output review
- Design and development verification
- Design and development verification review
- Design and development validation
- Design and development validation review
- Design and development transfer
Refer Annex 3 > 3.1 Design Phases > 3.1.2 Design Files of the TCF of External Nasal Splint
4. Product Verification: As a part of product verification, we have laid down in-house specification and verify the following
properties of External Nasal Splint: -
Refer Annex 3 > 3.8 Quality Plan of the TCF of External Nasal Splint
5. Product Validation: As a part of validation following activities are undertaken:
● Sterilization Validation: The devices are supplied as ETO sterilized. We have validated the ETO sterilization processes.
Refer Annex 3 > 3.3 Process Validation > 3.3.3 Sterilization validation of the TCF of External Nasal Splint
● Clinical Evaluation: EON Meditech Pvt. Ltd. has established, documented, and maintained throughout the life cycle an
ongoing process for identifying hazards associated with External Nasal Splint estimating and evaluating the associated
risks, controlling these risks, and monitoring the effectiveness of the controls. After risk mitigation proposals, risks have

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been reduced to acceptable individual levels and no high integrity level risks remain that require special consideration and
justification for acceptance. The proposed control measures to address individual risks do not generate additional risks.
Risk benefit analysis identifies benefit for use of the External Nasal Splint in preference to traditional methods that can be
employed to achieve the same clinical outcome. From the evaluation of results of the Risk Management process, it is
judged that the benefits from using External Nasal Splint outweigh the residual risks of its use, and as such the residual
risks are acceptable.
While conducting the Risk assessment device/body interaction, the clinical performances intended purpose and the claims
of the device have been specifically considered.
We have adequately demonstrated the conformity with the General Safety and Performance Requirements based on risk
management, clinical evaluation and Product specific testing carried out for the concerned product.
Hence EON Meditech Pvt. Ltd. has chosen to conduct clinical evaluation using literature search route rather than
conducting clinical investigation.
Refer Annex 6 > 6.4 Clinical Evaluation of the TCF of External Nasal Splint
● Usability Engineering Process: The devices in scope were developed as per IEC 62366:2015.
Refer Annex 6 > 6.5 Usability Engineering > 6.5.1 UEP of the TCF of External Nasal Splint
Refer Annex 6 > 6.5 Usability Engineering > 6.5.2 UER of the TCF of External Nasal Splint
6. Post Market Activities Post Market Surveillance study is planned to identify uncertainty about the safety and performance of
the device by collecting and analysing new relevant information.
Input Data for Post market surveillance shall include:
1. Post Market Surveillance
2. Vigilance
3. Advisory Notice

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4. Product Recall
5. Complaint Handling
6. Feedback
Refer Annex 7 > 7.1 PMS Plan of the TCF of External Nasal Splint
Refer Annex 7 > 7.2 PMSR of the TCF of External Nasal Splint
25. Justification for Non-applicability of PMCF
(As per “7. Definition of the scope of the clinical evaluation (Stage 0)” of MEDDEV 2.7.1 Rev. 4)
EON Meditech Pvt. Ltd. has decided not to carryout PMCF studies for External Nasal Splint in the scope by referring statement
mentioned as per the MEDDEV 2.12/2 Rev 2 guidelines. PMCF studies for External nasal splint in the scope is not required in which
the safety and performance are known already from previous use of the device and appropriately framed PMS activities provide
enough data to identify the risks.
We, EON Meditech Pvt. Ltd. has justified not to conduct PMCF study for as it is based upon the clinical equivalence which was well
established in market and its long terms clinical safety and performance are already known.
External Nasal Splint (Manufactured by EON External Nasal Splint (Manufactured by
Meditech Pvt. Ltd.) SPIGGLE & THEIS)
External Aluminium Nasal Splints External Aluminium Nasal Splint
External Thermoplastic Nasal Splints External Thermoplastic Nasal Splint
Table 13. – Device manufactured by EON Meditech Pvt. Ltd. and SPIGGLE & THEIS
The equivalence for these devices is performed based on:
- Same intended use, same contact site, similar patient population
- Similar design and similar specifications and properties
- Similar Principle of operation

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Circumstances where PMCF Data is indicated

Circumstances that may
Sr. No Applicability Justification and Supporting Documents
Justify PMCF Studies
External Nasal Splint manufactured by EON Meditech Pvt. Ltd. have
an Equivalent device which are already in market more than 10 years
Innovation, e.g., where the
and CE certified. The Equivalent devices have same intended use,
design of the device, the
contact site, similar patient population, similar design and similar
materials, substances, the
1 Not Applicable specifications and properties, and similar principle of operation, as
principles of operation, the
there is no difference in material selection. There are no novel
technology or the medical
features for the device.
indications are novel;
Refer: Annex6 > 6.4 Clinical Evaluation > 6.4.4. Equivalent Device
Content
2 Significant changes to the Not Applicable EON Meditech Pvt. Ltd. has neither done any significant changes in
products or to its intended use the product design, material, component, characteristics, nor to its
for which pre-market clinical intended use. Our device is similar in design as well as intended use
evaluation and re-certification to existing external nasal splint. The equivalence to equivalent device
has been completed is conformed in Clinical Evaluation Report. Safety and performance
of the device is assessed by review of literature as well as adverse
events reported of similar devices.
Refer: Annex6 > 6.4 Clinical Evaluation > 6.4.4. Equivalent Device
Content

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Circumstances that may

Sr. No Applicability Justification and Supporting Documents
Justify PMCF Studies
Annex 1 > 1.4 similar device report
An external nasal splint is a non-invasive device that does not come
in direct contact with the skin. There is no significant risk associated
with the use of an External Nasal Splint in the scope. We have
High product related risk e.g.,
identified all the risk related to design, Material, Components of
Based on design, materials,
3 Not Applicable device and reduced to ‘as far as possible’ level. Benefit Risk analysis
components, invasiveness,
is performed for all the risk, and any remaining risks for which
clinical procedures.
further control is not possible are mentioned in Instruction for Use.
Refer: Annex 5 > 5.3 Risk Management Report
Annex 2 > 2.2 Instruction for use (IFU)
4 Use of medical device in: Not Applicable External Nasal Splint is compatible and can applied to the Nasal
-Anatomical locations having Dorsum following self-adhesive tape, hence there are no high-risk
high risk - High risk target anatomical locations involved. The device is used for Adult and
populations Children. Children or Paediatrics, Geriatric is high-risk target
Severity of disease / population.
treatment challenges
Severity of disease:
External Nasal Splint is required in case of Septoplasty, Rhinoplasty,
Septoplasty and nasal fracture for the patients who have dislocation

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Circumstances that may

Sr. No Applicability Justification and Supporting Documents
Justify PMCF Studies
of nasal bones.
Although this procedure is considered as a safe procedure, there is
potential for both minor and major complications.

Treatment Challenges:
This procedure is practiced more than 30 years. It is a simple and safe
procedure.
According to the clinical evaluation of published literature,
demonstrated clinical safety and performance of the device for the
possible risk which are associated with the device such as localized
infection, scar formation, discomfort.

Refer: Annex 5 > 5.3 Risk Management Report

Annex 2 > 2.2 Instruction for use (IFU)
Annex 6>6.4 Clinical Evaluation>6.4.6 Clinical Evaluation Report
5 Questions of ability to Not Applicable External Nasal Splint in the scope already have an equivalent device;
generalize clinical hence no clinical investigations were conducted for the device. EON
investigation results Meditech Pvt. Ltd. will collect feedbacks and post market data for
External Nasal Splint in the scope.

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Circumstances that may

Sr. No Applicability Justification and Supporting Documents
Justify PMCF Studies
Refer: Annex 7 >7.1 PMS Plan
Annex 7>7.2 PMSR Report
There is no new information on safety and performance emerged.
Safety and performance of EON external nasal splint is ensured by
conforming to applicable quality standards for manufacturing as well
as well as operational with respect to safety at every level.
Unanswered questions of Identification of risks associated with the use of the device by
6 long-term safety and Not Applicable regularly conducting Post Market Surveillance which includes
performance Vigilance data search – MAUDE, MHRA, Health Canada, ANVISA,
TGA, PMDA, review of literature, Customer complaints, any safety
action etc. and ensuring risk mitigation by implementation of action
where required.
Refer: Annex 7>7.2 PMS Report
No adverse event is reported for External Nasal Splint in the scope
Results from any previous
manufactured by EON Meditech Pvt. Ltd. However, we have
clinical investigation,
conducted a vigilance data search from- MAUDE (United States),
7 including adverse events or Not Applicable
MHRA (United Kingdom), ANVISA (Brazil), Health Canada, TGA
from post-market surveillance
SARA(Australia) and PMDA (Japan).
activities
Refer: Annex 7>7.2 PMS Report
8 Risks identified from the Applicable We have performed clinical evaluation (Annex 6>6.4 Clinical

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Circumstances that may

Sr. No Applicability Justification and Supporting Documents
Justify PMCF Studies
Evaluation>6.4.6 Clinical Evaluation Report) External Nasal Splint
literature or other data
in the scope and the risk identified from the literatures are covered in
sources for similar marketed
the risk management report
devices;
Refer: Annex 5>5.3 Risk Management Report
External nasal splint does not come in contact with any medical
products/treatment, as they are used post-operatively. Also, it does
Interaction with other medical
9 Not Applicable not incorporate any medicinal substance.
products or treatments
The device does not have direct contact with the skin.
Refer: Annex 6 > 6.6 Declarations
A vigilance database search is performed and we take corrective
action against the reported events. Also, we conduct post market
Verification of safety and
surveillance. The data obtained from PMS and vigilance data base
performance of device when
will be utilized to update the risk management and clinical
10 exposed to a larger and more Not Applicable
evaluation.
varied population of clinical
Refer: Annex 7>7.2 PMS Report
users
Refer: Annex 5>5.3 Risk Management Report
Annex 6>6.4 Clinical Evaluation>6.4.6 Clinical Evaluation Report

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Circumstances that may

Sr. No Applicability Justification and Supporting Documents
Justify PMCF Studies
Emergence of new
There is no emergence of any new information on safety or
11 information on safety or Not Applicable
performance of all medical devices in the scope.
performance
The CE marking is based on the Clinical equivalence. External Nasal
Splint in the scope is equivalent to CE marked products mentioned
above. (Refer Annex 6>6.4 Clinical Evaluation>6.4.6 Clinical
Evaluation Report). And we have PMS procedure (Refer Annex 3 >
Where CE marking was
12 Applicable 3.4 Procedures & Regulatory Strategy > PMS Procedures) in place
based on equivalence.
to gain data regarding the safety and performance of the concerned
device and equivalent device. Also, all the risks related to the life
cycle of the concerned device are identified, evaluated and mitigated
to as far as possible (Refer Annex 5 Risk Management File)
Table 14. – PMCF Justification Data
Post market surveillance is an integral part of the quality management system in EON Meditech Pvt. Ltd. Following data can be gained
from the PMS activity:
- Detection of manufacturing problems
- Product quality improvement
- Confirmation (or otherwise) of risk analysis
- Knowledge of performance
- Knowledge of changing performance trends

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- Knowledge of performance in different user populations

- Feedback on IFU
- Feedback on customer satisfaction
- Identification of vigilance reports
- Knowledge of ways in which the device is misused
- Feedback on continuing market viability’s
Conclusion
It is therefore proposed that EON Meditech Pvt. Ltd. will perform review of any customer complaints or adverse events data received
against these devices or data published on similar devices obtained during reviews conducted, as part of their routine post market
surveillance. This is in accordance with EON Meditech Pvt. Ltd. Quality Management Procedure for Post Market Surveillance. Since the
long-term safety and clinical performance are already known to
provide sufficient data to address the risks, we conclude that PMCF activity is not necessary to be carried out.
Annex 6>6.3 Post Market Clinical Follow-up >PMCF Justification of Non applicability
26. Demonstration of Equivalence
(As per Point No. “4.2 Demonstration of Equivalence (only when equivalence is claimed)” available in “Section “A9. Clinical
evaluation report - proposed table of contents, examples of contents” & “A1. Demonstration of equivalence” of MEDDEV 2.7.1
Rev. 4)

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Clinically
- Used for the same medical condition or intended purpose (including similar
severity and stage of disease, medical indication)
- At the same site in the body
- In a similar population (Including age, gender, anatomy, Physiology)
- Have Similar kind of user
- not foreseen to deliver different performance
- Have similar relevant critical performance according to the expected clinical
effect for a specific intended purpose

Technically
- be of similar design
- Used under similar condition of use
- Have similar specification & properties (e.g., Physiochemical properties, tensile
strength, viscosity, surface characteristics, wavelength, software algorithms, porosity,
particle size, nanotechnology, specific mass)
- Use similar deployment method if relevant
- Have similar principle of operation and critical performance

Biologically
- Use same material or substance in contact with the same human tissue or body fluid
- for a similar kind and duration of contact and similar release characteristics of
substance
- including degradation products and leachable

Figure 4. – Evaluation of Equivalence

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Clinical, Technical and Biological characteristics shall be taken into consideration for the demonstration of equivalence:
● Clinical:
- used for the same clinical condition (including when applicable similar severity and stage of disease, same medical
indication), and
- used for the same intended purpose, and
- used at the same site in the body, and
- used in a similar population (this may relate to age, gender, anatomy, physiology, possibly other aspects), and
- not foreseen to deliver significantly different performances (in the relevant critical performances such as the expected
clinical effect, the specific intended purpose, the duration of use, etc.).
● Technical:
- be of similar design, and
- used under the same conditions of use, and
- have similar specifications and properties (e.g., physicochemical properties such as type and intensity of energy, tensile
strength, viscosity, surface characteristics) and
- use similar deployment methods (if relevant), and
- have similar principles of operation and critical performance requirements.
● Biological:
- Use the same materials or substances in contact with the same human tissues or body fluids.
- Exceptions can be foreseen for devices in contact with intact skin and minor components of devices; in these cases, risk
analysis results may allow the use of similar materials taking into account the role and nature of the similar material.

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- Different aspects of equivalence and compliance to different Essential RequiremNs can be affected by materials. Evaluators
should consider biological safety (e.g., in compliance to ISO 10993) as well as other aspects necessary for a comprehensive
demonstration of equivalence. A justification explaining the situation should be provided for any difference.
27. Risk Analysis
(As per Section 7 “Definition of the scope of the clinical evaluation (Stage 0)” of MEDDEV 2.7/1 Rev.4)
Risk management have been performed for the External Nasal Splint in accordance with risk management procedure and planning
of the risk management covering device under the evaluation.
This risk analysis is a component of the risk analysis process and is used to identify risks of the device. The risk analysis includes
aspects associated with the medical procedure for which the device is intended, technical solution adopted, design, process and
aspects specific to the use of the particular device. The risk analysis in conjunction with conclusions drawn from the evaluation of
pertinent technical characteristics and literature based clinical data for External Nasal Splint shall be used to demonstrate
compliance with the EN ISO 14971:2019/A11:2021: Application of Risk Management to Medical Devices: Details can be found
in the Risk management report for External Nasal Splint.
All the risks are identified covering the entire life cycle of the product with reference to Annexure C of EN ISO
14971:2019/A11:2021. Risk estimation and evaluation of all the hazards is mitigated as per the risk acceptability matrix with
reference to Annexure D of the standard.
All individual risks are subjected to benefit risk analysis. The products confirm to all the safety and performance requirements with
respect to the indented use of the device. The risk associated with the indented use of the device is acceptable when weighed against
benefit to the patient.
We have an established procedure in place that provides the information to identify the hazards associated with the project to
estimate and evaluate the associated risks, to control these risks and to monitor the effectiveness of the controls.
Refer Risk Management File in Annex 5 of the External Nasal Splint Technical Construction File

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27.1 Potential Risks –

EON Meditech Pvt. Ltd. has identified and documented known and foreseeable hazards associated with the External
Nasal Splint based on the intended purpose and its reasonably foreseeable misuse as mentioned above and the
characteristics related to safety in both normal and fault conditions.
According to EN ISO 14971:2019/A11:2021 - Medical devices — Application of risk management to medical devices, the
Product characteristics that could have an impact on the safety include:
● Raw Material Hazards:
- Raw material and packaging material not as per specification
- Raw Material not tested according to standard test method
- Use of raw materials and packaging materials other than approved materials
- Contaminants on raw material and packaging material
● Biological Hazards
- High count of viable and nonviable organisms (bioburden) on the final product
- Presence of extractable metal in finished product
- Failure in Bacterial Endotoxicity/ Pyrogens (Pyrogenicity tests)
● Design and Development Related Hazards
- Inadequate specification of design parameters
- Design verification and validation not done properly
● Manufacturing Related Hazards:
- Incorrect validation of Manufacturing process parameters
- Size specifications of the product is not as intended

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- Unintentional ingress of substances into device

- Improper in-process inspection and final product inspection of the product
- Inadequate maintenance of machines and equipment used in manufacturing
- Broken Device/partially cut
- Mixing of Sterilized and non-sterile products
- Mixing of products during packaging
- Calibration of instrument is not proper
- Improper cleaning of device
- Improper machining: Punching
- Foreign particles or pests/insect in manufacturing environment resulting in contamination of device
- Improper assembly components of device
● Sterilization Related Hazards
- Improper Sterilization of the device
- High exposure or less exposure of EO during sterilization
- Residual EO on the products
● Labelling Hazards
- Inadequate labelling
- Poor product description like lot no., product name, manufacturing date, expiry date etc.
- Incomplete/incorrect information provided with the device i.e., warnings, precautions, contraindications etc.
● Packaging Related Hazards

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Product Name: External Nasal Splint Page 64 of 132

- Damage to the device packaging

- Incorrect size or type of the device placed in a packaging
- Inadequate packaging
● Environmental Hazards
- Storage conditions not maintained for finished goods at manufacturer side
● Transport Hazard
- Risk of device being damaged during transportation
- Risk of loss of stability of the product if storage condition is not maintained during transportation of the product
● User Related Hazards
- Re- sterilization of device
- Re use of product
- Product used after expiry date
- Deliberate off label use
- Accidental off label use
- Device operated by unskilled/ untrained personnel
- Improper selection of the size and type of the device
- Product Used from damaged/ broken package
- Improper Handling of the Device
● Disposal Related Hazards
- Improper disposal of the Device

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● Clinical Hazards
- Localized Infection
- Discomfort
- Scar formation
● For the above-mentioned risks, if the residual risks were not judged acceptable using the criteria established in the risk
management plan and further risk control was not practicable, EON Meditech Pvt. Ltd. gather and review data and literature
to determine if the benefits of the intended purpose outweighed this residual risk.
● If this evidence did not support the conclusion that the benefits outweighed this residual risk, then EON Meditech Pvt. Ltd.
consider modifying the medical device or its intended purpose. Otherwise, this risk was kept unacceptable.
● If the benefits outweigh the residual risk, then we did proceed further.
● The results of benefit-risk analysis have been recorded in Risk Management Report.
● We have implemented our Risk Management in a way that the results of Risk Management are evaluated in both Qualitative
& Quantitative ways in order to determine the Residual Risks.
● The benefits are estimated based on the following aspects:
1. Expected benefit- Use of External Nasal Splint achieves the “Healing of bone fracture”
2. Type of benefit- The device is useful in medical conditions- Septoplasty, Rhinoplasty, Septorhinoplasty, Nasal Fracture
3. Magnitude of benefit- Complete nasal fracture healing, with the reduction in edema.

● Calculation of Benefit and risk:

Intended Purpose An external Nasal Splint is used for splinting of the nasal dorsum after a nasal
surgical procedure. It protects the nose from external trauma and prevents the

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dislocation of nasal bones.

1 Septoplasty
2 Rhinoplasty
Indication for use 3 Septorhinoplasty
4 Nasal Fracture

1 Provides Compression to the nose

Performance 2 Reduce edema

3 Stabilization of Nasal framework

Benefits Healing Bone Fracture

Risks Mild Discomfort, Scar formation, localized infection
Table 15. – Calculation of Benefit and Risk
We shall search the literatures for the performance criteria and risks identified in the above table and shall count the number of
patients who have actually achieved the benefits and faced risks.
The benefit-
Benefit Benefit
Description of Level (Benefits)
grade weight
I 1 Healing Bone Fracture
Table 16. – The Benefit
“External Nasal Splint is employed for “Healing Bone Fracture” is the ultimate benefit of the device and assigned a weigh of 1; as
per guidance document MEDDEV 2.7/1, Rev. 4, A7.2: “A large benefit, even if experienced by a small population, may be
significant enough to outweigh risks, whereas a small benefit may not, unless experienced by a large population of subjects.”

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So, benefit will be calculated as:

Benefit Value = Benefit weight X No. of patient
Risk-
Severity Levels Ranking Description of Level
Negligible 1 Results in Mild discomfort
Minor 2 Results in Scar formation

Serious 3 Results in localized infection

Critical 4 Results in permanent impairment or life-threatening injury

Catastrophic 5 Results in patient death
Table 17. – Severity Levels
Risk Value = Severity X Number of patients
Benefit Risk Ratio = Benefit Value/Risk Value
The benefit-risk ratio should always be greater than one. This is the overall risk acceptability criteria.
Refer Annex 5 > 5.1 Risk Management Policy of the TCF of External Nasal Splints
Refer Annex 5 > 5.2 Risk Management Plan of the TCF of External Nasal Splints
Refer Annex 5 > 5.3 Risk Management Report of the TCF of External Nasal Splints

28. Establishing the State-of-the-Art (SOTA), Similar Device for Safety and Performance and Alternative Device or Treatment
The SOTA have been considered in this clinical evaluation planning and its evaluation will be completed during CER execution of
the device in scope. This is to be carried out based on the EU MDR 2017/745 Annex XIV section 1a – “an indicative list and
specification of parameters to be used to determine, based on the state of the art in medicine, the acceptability”. EON Meditech Pvt.

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Ltd. has also established the different clinical outcome parameters which are to be used to demonstrate that the clinical safety,
performance and benefits claimed by the organization are achieved.
For the SOTA evaluation below mentioned steps are followed –
The primary purpose of the SOTA evaluation is to define what ‘acceptable’ looks like for a given patient population.
Evidence relevant to the safety, performance and benefit-risk determination for the subject device – External Nasal Splint shall be
mapped against the outcome parameters mentioned in this section and benchmarks to demonstrate that they have been satisfactorily
achieved.

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Define the Intended Purpose of the device in scope

Identification of Clinical Safety Claims, Performance Claims & Clinical Benefits

Benefit/Risk Evaluation & Implementation of the GSPRs

Identification of the indicative list of the outcome parameters which could be used to
demonstrate that the intended performances, benefits and safety requirements are achieved

SOTA Evaluation

Final List of Outcome Parameters and Benchmarks for the specified Outcome Parameters

Device Data Collection & Appraisal

Data Mapping & Conclusions Including Benefit-Risk

Figure 5. - Establishing the State-of-the-Art (SOTA)

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29. Clinical Outcome Parameters

We have referred performance and safety related data from IFU of similar product which is already in market and also
In order to identify the clinical outcome parameters, we considered below mentioned parameters:
Inputs to be considered for
Sr. No. the Clinical Outcomes Specifications of the inputs considered Criteria
measurements

1. Intended Purpose An external Nasal Splint is used for splinting of CO1

the nasal dorsum after a nasal surgical
procedure. It protects the nose from external
trauma and prevents the dislocation of nasal
bones.
2. Intended Patient Population All patient populations (including Pediatric) CO2

3. Biological Parameters Sterility/Sterilization CO3.1

Raw material CO3.2

Point of Contact & Duration of Contact CO3.3

4. Equivalence Parameters Clinical CO4.1

(As per the section 13.16 of
Technical CO4.2
this clinical evaluation plan)
Biological CO4.3

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Inputs to be considered for

Sr. No. the Clinical Outcomes Specifications of the inputs considered Criteria
measurements

5. Undesirable Side effects Minor Scar Tissue CO5.1

Localized Infection CO5.2

Mild discomfort CO5.3

6. Natural History of the Nature: In nasal surgeries to protects the nose CO6.1
medical condition from external trauma and prevents the
dislocation of nasal bones. (Indication:
Septoplasty / Rhinoplasty)

Type: Non-invasive Use CO6.2

Duration: Short term CO6.3

History: Successful/Not successful CO6.4

7. Intended User It shall be used by practitioners’ health CO7.0

professionals, for example doctors specializing
in cosmetic surgery or plastic, facial trauma
surgeons and otolaryngologists.

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Inputs to be considered for

Sr. No. the Clinical Outcomes Specifications of the inputs considered Criteria
measurements

8. Clinical Benefits, Clinical Benefits – Healing Bone fracture CO8.1.

Performance & Safety claims
Clinical performance characteristics CO8.2

4 Provides Compression to the nose CO8.2

5 Reduce oedema CO8.2

6 Stabilization of Nasal CO8.2

framework

Clinical Safety Claims – CO8.3

o The device in scope is safe for use in all patient CO8.3.1

population.

The device in scope is to be used as a single CO8.3.2

used device.

The device in scope is to be used by CO8.3.3

experienced healthcare professional.

Device shall show thermoplastic CO8.3.4

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Inputs to be considered for

Sr. No. the Clinical Outcomes Specifications of the inputs considered Criteria
measurements

characteristics/device shall be easily foldable at

nose septum side.

The device in scope is easy to use. CO8.3.5

9. State of the Art treatment Denver Nasal splint/Invotec CO9.1

options / Medical Alternative
Steri-strip/micropore tape CO9.2
treatment options
POP Cast splint CO9.3

10. Benchmark/Equivalent Spiggle Theis CO10

Devices
11. History of medical devices History CO11

12. Handling of device For thermoplastic devices- Soften the splint in CO12.1
160-180°F (71-82°C) water for 30 to 60
seconds. 10. Remove the splint from water
using forceps or a tongue depressor to avoid
burning fingers.
Apply overlapping paper tape to nose CO12.2

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Inputs to be considered for

Sr. No. the Clinical Outcomes Specifications of the inputs considered Criteria
measurements

Table 18. – Clinical Outcome Parameters

Possible Clinical Outcomes:
Sr. No. Type of Outcome Description
1 Primary Outcome PCO.1 (Benefit) Healing Bone fracture
Device broken /Patient
2 Secondary Outcome PCO.2 (Device Failure)
requires re-surgery
- Minor Scar Tissue

3 Tertiary Outcome PCO.3 (Side effect) - Localized Infection

- Mild discomfort

Table 19. – Possible Clinical Outcomes

30. Current Knowledge & State-of-the-Art of Device
(As per Section 8.2 “Data retrieved from literature”, Appendix A4 “Sources of literature” & Appendix A5 “Literature search and
Literature review protocol, key elements of MEDDEV 2.7/1 Rev.4)
There is a data which is not held by the EON Meditech Pvt. Ltd. for that we have planned an appropriate Literature searching to
retrieve data that is needed for clinical evaluation. This helps EON Meditech Pvt. Ltd.to identify potential sources of clinical data for
establishing Current Knowledge/ the state of the art.

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It includes applicable standards and guidance documents, data that relate to benchmark devices, other devices, critical components
and medical alternatives or to the specific medical conditions and patient populations intended to be managed with the device. The
data are typically needed in order to
- describe the clinical background and identify the current knowledge/ state of the art in the corresponding medical field,
- identify potential clinical hazards (including hazards due to substances and technologies, manufacturing procedures and impurity
profiles),
- justify the validity of criteria used for the demonstration of equivalence (if equivalence is claimed),
- justify the validity of surrogate endpoints (if surrogate endpoints are used).
There are different sources of clinical literature that can be searched for clinical evaluation. And these searches provide important
data that includes Expert documents produced by professional medical associations that are important for assessment of current
knowledge/ the state of the art, including clinical practice guidelines and consensus statements.
A review of the current knowledge/ the state of the art needed for the proper conduct of the appraisal and analysis of the clinical data
of the device under evaluation and the equivalent device (i.e., applicable standards and guidance documents, information on the
medical conditions that are relevant to the clinical evaluation, therapeutic/ management/ diagnostic options available for the intended
patient population, etc.).
The Current knowledge/ state of the art helps in the evaluation of acceptability of the benefit/risk profile.
- Tripod Suspension and Stabilization Technique
- A Novel Material External Nasal Splint
- Polyvinyl Siloxane External Nasal Splint
- Plaster of Paris External Nasal Splint
- Steri-Strips
Analysis of this will be done in literature appraisal and evidences will be recorded in clinical evaluation report.

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Product Name: External Nasal Splint Page 76 of 132

Refer Annex 6 > 6.4 Clinical Evaluation > 6.4.6. Clinical Evaluation Report
31. Applicable standard and Guidance Documents
Refer Annex 4. LOAS and GSPR > 4.1 LOAS & Refer Section 9 Guidelines and Regulations of this CEP
32. Intended clinical benefits to the patients:
Healing Bone fracture
33. Clinical Performance & Safety Requirements are to be verified
(As per Section 10 “Analysis of the clinical data (Stage 3)” of MEDDEV 2.7/1 Rev.4)
EON Meditech Pvt. Ltd. has implemented and maintains a PMS system that routinely monitors the clinical performance and clinical
safety of the External Nasal Splint. PMS regularly generates new data (e.g., safety reports, results from published literature,
registries, and other data about device usage).
EON Meditech Pvt. Ltd. is evaluating for information that has a potential to change the evaluation of the risk/benefit profile, and the
clinical performance and clinical safety of the External Nasal Splint in a specific timely manner. Those data are importing into the
clinical evaluation process in a regular interval.
EON Meditech Pvt. Ltd. appraising and analyzing the searched literature data for the Clinical performance & Clinical Safety of the
External Nasal Splint in order to comply with the evaluation of risk/benefit profile as per applicable regulatory requirements.
- Safe in all patient population
- The device is safe to use & easy to handle
- Device is intended to be used by health professionals, for example, by otorhinolaryngology (ENT).
- The device is intended for short term & single use only. External Nasal Splint (Thermoplastic) shall be easily foldable at nasal
septum side
- Provides Compression to the nose
- Reduce edema

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Product Name: External Nasal Splint Page 77 of 132

- Stabilization of Nasal framework

- Discomfort to the Patient
- Infection to the Patient
- Scar formation to the Patient
Analysis of this will be done in literature appraisal and evidences will be recorded in clinical evaluation report.
Refer Annex 6 > 6.4 Clinical Evaluation > 6.4.6. Clinical Evaluation Report
34. Data Source and Type of Data to be Used
(As per Section 7 “Definition of the scope of the clinical evaluation (Stage 0)” of MEDDEV 2.7/1 Rev.4)
Data relevant to the clinical evaluation may be generated and held by the manufacturer or available from scientific literature.
EON Meditech Pvt. Ltd. has planned to generate and hold the data from different types of Sources available from literature that is
relevant for Clinical Evaluation. These Sources & Types of data are briefly mentioned in the below section ( Section 32) of this
document.
35. Identification of Pertinent Data
(As per Section 8 “Identification of Pertinent data (Stage 1)” of MEDDEV 2.7/1 Rev.4)

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Product Name: External Nasal Splint Page 78 of 132

Identification of
Pertinent data

Data Held by Data retrieved

Manufacturer from literatures

PMS-Report,
PMCF, RMR, Pre-Clinical Performance
CAPA, Incident study reports, safety data taken
reports Usability from all appraised
literatures

Figure 6. – Identification of Pertinent data

35.1 Types of Data to be Used in Clinical Evaluation
● Data generated and held by the manufacturer: Data generated and held by the EON Meditech Pvt. Ltd. typically
include the following items -
- All pre market clinical investigations
- All clinical data generated from risk management activities and the PMS programs
- Relevant pre-clinical studies
● Data retrieved from literature: Literature searching is used to identify data not held by the EON Meditech Pvt. Ltd. that
are needed for the clinical evaluation
35.2 Data Source
● Data generated and held by the manufacturer:

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Product Name: External Nasal Splint Page 79 of 132

- Risk Associated with device as intended

All the risks are identified covering the entire life cycle of the product with reference to Annexure
C of EN ISO 14971:2019/A11:2021. Risk estimation and evaluation of all the hazards is mitigated as per the risk
acceptability matrix with reference to Annexure D of the standard. All individual risks are subjected to Benefit-Risk
Analysis. The products confirm to all the safety and performance requirements with respect to the intended use of
the device. The risk associated with the intended use of the device is acceptable when weighed against benefit to the
patient. We have an established procedure in place that provides the information to identify the hazards associated
with the project to estimate and evaluate the associated risks, to control these risks and to monitor the effectiveness
of controls.
Refer Annex 5 > 5.3 Risk Management Report of the TCF of External Nasal Splints
- Post Market Surveillance:
EON Meditech Pvt. Ltd. has prepared a Post Market Surveillance Plan to reduce the identified uncertainty about the
safety and performance of External Nasal Splint, manufactured by EON Meditech Pvt. Ltd.by collecting and
analysing new relevant information.
It aims to:
- To monitor the safety, performance, and usability of the External Nasal Splint to characterize the degree of
satisfaction of the healthcare professionals with the medical device.
- Obtain information on the long-term safety and performance of the medical device
- Invoke company feedback procedures to further investigate this issue. Collect data on the prevalence of the use
and assess if current clinical data supports the new usage. Other actions can be considered necessary, such as
updating technical documentation, evaluating the risk associated with the new intended use

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 Product Name: External Nasal Splint Page 80 of 132

- Identify and work upon the misuse incidents of the medical device
- Monitor continued satisfaction of the users with the medical device and the evolution of the state of the art.
- Identify if any improvements can be made to the medical device
This post-market surveillance process is consistent with relevant international standards, in particular ISO
13485:2016 and EN ISO 14971:2019/A11:2021. This document describes a proactive and systematic process that
EON Meditech Pvt. Ltd. can use to collect and analyse appropriate data, to provide information for the feedback
processes and use this to meet applicable regulatory requirements to gain experience from the post-production
activities. The output of this process can be used:
- as input into product realization;
- as input into risk management;
- for monitoring and maintaining product requirements;
- for communicating to regulatory authorities; or
- as input into improvement processes.
PMS procedure is established and implemented to collect the post production data for the marketed device PMS
regularly generates new data (e.g., safety reports, results from published literature, and other data about device usage
like product feedback from the customer, customer complaints, adverse events, vigilance data, audits etc.). Those
data are evaluated for information that has a potential to change the evaluation of the benefit/risk profile, and the
clinical performance and clinical safety of the device. Those data are required to be fed into the clinical evaluation
process in a timely manner.
Input Data for Post market surveillance shall include:

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Sr. Type of Responsible Frequency

Input Key Indicators Threshold values Actions
No. Analysis person of review
1. Vigilance Database  Number of  0 adverse event This covers the actions to Quantitative Technical Monthly
(Recall & Advisory adverse reporting for the be taken once EON Director
Notices) events subject device. Meditech Pvt Ltd. or
reported for  0 advisory notice any other Authority
As per EU MDR own issued related to receives information
2017/745, Annex III device. the device in concerning an Incident
Technical  Number of scope involving an External
Documentation on Advisory Nasal Splint. An Incident
Post Market Notice being any malfunction or
Surveillance, Clause issued deterioration in the
1.1.a, indent 1 characteristics and/or
Refer PROCEDURE performance of an
for Product recall and External Nasal Splint,
Advisory notice as well as any inadequacy
(Document No.: in the labelling or the
EMT-PM-05 ) instructions for use which
directly or indirectly
might led to the death of
a patient, or user or of
other persons or to a

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Product Name: External Nasal Splint Page 82 of 132

Sr. Type of Responsible Frequency

Input Key Indicators Threshold values Actions
No. Analysis person of review
serious weakening in
their state of health. It
follows the Guidelines on
a Medical Devices
Vigilance System and is
applicable to “Incidents”.
If there are any of the
adverse events, advisory
notice, field safety
corrective actions or
product recalls identified
involving External Nasal
Splint manufactured by
EON Meditech Pvt Ltd.
or any of its competitor
during the concerned
period of Post Market
Surveillance activity, this
data will be verified and
fed into the report. This

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Product Name: External Nasal Splint Page 83 of 132

Sr. Type of Responsible Frequency

Input Key Indicators Threshold values Actions
No. Analysis person of review
data is analysed to
identify any potential
foreseeable risk or
problems occurring from
the risk already covered
in our risk assessment.
The control measures are
verified for their
effectiveness. If the need
arises to take any action
on our current marketed
product (External Nasal
Splint), the management
decides the action and
implements immediately,
this is also discussed and
noted during MRM.
2. Trend Reporting  Number of  0 trend reports Annually EON Meditech Quantitative Technical Yearly
trend Pvt Ltd. statistically Director
As per EU MDR check the significant

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Product Name: External Nasal Splint Page 84 of 132

Sr. Type of Responsible Frequency

Input Key Indicators Threshold values Actions
No. Analysis person of review
2017/745, Annex III
Technical
Documentation on
Post Market increase in the frequency
Surveillance, Clause or severity of incidents
1.1.a, indent 2, indent that are not serious
3, Clause 1.1.b, indent incidents or that are
5 expected undesirable
reports
Refer PROCEDURE side- effects that could
for Data Analysis have a significant impact
(Document No.: on the benefit-risk
EMT-PM-12) analysis of External
Nasal Splint.
Refer PROCEDURE
for Vigilance(EMT-
PM-25)
3. Literature Search and Number of  0 new literatures Various literatures shall Quantitative Sr QA Yearly
clinical evaluation Literatures obtained from be analysed to understand Executive
affecting the clinical literature current changes and
As per EU MDR Benefit Risk review which additional information to

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Product Name: External Nasal Splint Page 85 of 132

Sr. Type of Responsible Frequency

Input Key Indicators Threshold values Actions
No. Analysis person of review
2017/745, Annex III Ratio can modify the be assessed to add and
Technical benefit risks confirm our existing
Documentation on ratio of the clinical evaluation of
Post Market device in scope. External Nasal Splint.
Surveillance, Clause This literature search
1.1.a, indent 4 shall be carried out
Refer PROCEDURE yearly, to identify if some
for Clinical Evaluation new technologies have
(Document No.: - emerged or if there is any
EMT-PM-34) requirement to changes to
be made to the existing
External Nasal Splint or
the equivalence claimed
still remains appropriate.
The new searches are
included in the Clinical
evaluation report when
necessary. The
conclusions of this search
are fed into the PMS

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Product Name: External Nasal Splint Page 86 of 132

Sr. Type of Responsible Frequency

Input Key Indicators Threshold values Actions
No. Analysis person of review
Report.
New & Revised
regulatory
requirements &
external standards
During every
Management review
As per EU MDR
meeting, new revised
2017/745, Annex III
regulatory requirements Senior
4. Technical Every 6
-- -- and/or external standards – Executive-
Documentation on months
shall be analysed. If any QA
Post Market
new information is
Surveillance, Clause
received, that will be
1.1.a, indent 4
considered a PMS input.
Refer PROCEDURE
for Document Control
(Document
No.:EMT-PM-01)
5. Customer Feedback Number of  0 Negative Customer feedbacks or Quantitative Senior Monthly
Information feedback Feedbacks of suggestions other than & Executive-
forms Design and complaints are collected

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Product Name: External Nasal Splint Page 87 of 132

Sr. Type of Responsible Frequency

Input Key Indicators Threshold values Actions
No. Analysis person of review
As per EU MDR collected manufacturing throughout the year and Qualitative QA
2017/745, Annex III  Customer shall be reviewed and
Technical Customer satisfaction analysed understanding
Documentation on Satisfaction with respect to the satisfaction of the
Post Market Quality and External Nasal Splint. It
Surveillance, Clause packaging helps to improve the
1.1.a, indent 5 should not be safety and performance
Refer PROCEDURE below “On-Par”. in-order to improve the
for Customer customer satisfaction
Feedback and analysis
(Document No.:
EMT-PM-18);
Procedure for End
user Feedback and
analysis (Document
No.: EMT-PM-18);
Procedure for Internal
Feedback and analysis
(Document No: EMT-

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Product Name: External Nasal Splint Page 88 of 132

Sr. Type of Responsible Frequency

Input Key Indicators Threshold values Actions
No. Analysis person of review
PM-18)
6. Handling of Number of Not more than 10 This is intended to fully Quantitative Senior Monthly
Complaints complaints complaints directly examine the customer Executive-
affecting safety and complaints to determine QA
As per EU MDR performance of the the cause and take the
2017/745, Annex III device required remedial action,
Technical determine methods to
Documentation on preclude re-occurrence of
Post Market the problem and to keep
Surveillance, Clause the customer fully
1.1.a, indent 5 informed. The complaints
Refer PROCEDURE received throughout the
for Customer year are documented.
Complaint Cum The result and conclusion
Regulatory Report of this analysis is
(Document No.: reviewed during PMS
EMT-PM-04 ) and considered for
evaluating the External
Nasal Splint
performance and safety.

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Product Name: External Nasal Splint Page 89 of 132

Sr. Type of Responsible Frequency

Input Key Indicators Threshold values Actions
No. Analysis person of review
The annual data of
customer complaint is fed
into the PMS Report and
it is an input for the risk
management to verify
and if any risk is
identified, effective
control measures will be
taken to maintain the
safety and performance
of the External Nasal
Splint. It is a continuous
improvement in user
safety, regulatory
compliance, and
customer satisfaction by
establishing a complaint
handling process in EON
Meditech Pvt. Ltd..

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Product Name: External Nasal Splint Page 90 of 132

Sr. Type of Responsible Frequency

Input Key Indicators Threshold values Actions
No. Analysis person of review
Publicly available
information about
similar devices

As per EU MDR
EON Meditech Pvt. Ltd.
2017/745, Annex III
shall carry out the activity
Technical
of PMS of
Documentation on
similar/equivalent Senior
7. Post Market
-- -- devices as and when – Executive- Half-yearly
Surveillance, Clause
necessary. We shall also QA
1.1.a, indent 6
keep the updates
Refer PROCEDURE
regarding their websites
for PMS (EMT-PM-
and publications.
27)

Refer PROCEDURE
for Clinical Evolution
Plan (EMT-PM-34)
8. Sales Data – – Annually, EON – Director- Yearly
As per EU MDR Meditech Pvt Ltd.

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Product Name: External Nasal Splint Page 91 of 132

Sr. Type of Responsible Frequency

Input Key Indicators Threshold values Actions
No. Analysis person of review
2017/745, Annex III
Technical
evaluate the sales volume
Documentation on
of the External Nasal
Post Market
Splint and estimate
Surveillance, Clause
evaluation of the size and Technical
1.1.b, indent 4
other characteristics of
Refer PROCEDURE
the population using the
for PMS (EMT-PM-
External Nasal Splint.
27)

9. Salesforce, Distributor  Number of Marketing department Quantitative Director- Yearly

& Tradeshow open shall be in touch with our Technical
feedback Comments Salesforce, Distributor &
or inquiry Tradeshow feedback to
As per EU MDR from  0 open understand if there are
2017/745, Annex III intended Comments or any changes in their
Technical user inquiry from procedures which can
Documentation on intended user affect our product
Post Market conformity (External
Surveillance, Clause Nasal Splint). The Sales

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Product Name: External Nasal Splint Page 92 of 132

Sr. Type of Responsible Frequency

Input Key Indicators Threshold values Actions
No. Analysis person of review
1.1.b, indent 4
and distribution data are
Refer PROCEDURE
analysed and the
for PMS (EMT-PM-
conclusions are fed into
27)
the PMS Report.

10. Corrective action and  Number of 0 open CAPA This is intended to ensure Quantitative Senior Monthly
preventive action open CAPA exceeding the that corrective and Executive-
timelines defined in preventive action is a QA
As per EU MDR procedure of CAPA vital closed loop system
2017/745, Annex III of root cause analysis,
Technical documented action,
Documentation on verification of
Post Market effectiveness, and
Surveillance, Clause prevention of recurrence.
1.1.b, indent 8 The Corrective actions
Refer PROCEDURE and preventive actions (if
for Corrective Action any), are analysed and
(Document No.:EMT- identify any potential
PM-13) foreseeable risk, system
as well as product

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Product Name: External Nasal Splint Page 93 of 132

Sr. Type of Responsible Frequency

Input Key Indicators Threshold values Actions
No. Analysis person of review
performance, opportunity
for improvements in-
order to maintain the
quality and safety of the
External Nasal Splint.
11. Internal & External  Number of  0 Major non- This is intended to ensure Quantitative Senior Half-
Auditing non- conformity and that the Quality Executive- Yearly
conformity 10 minor non- Assurance System is QA
As per EU MDR conformity operating effectively and
2017/745, Annex III during Internal to ensure that personnel
Technical and External fulfil their responsibilities
Documentation on Audits. and duties adequately.
Post Market The activities in this
Surveillance, Clause procedure will assure the
1.1.b, indent 8 EON Meditech Pvt Ltd..
Refer PROCEDURE Quality objectives and
for Internal Audit requirements are met.
(Document Also, the comments
No.:EMT-PM-10) raised by external audits
shall be part of analysis

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Product Name: External Nasal Splint Page 94 of 132

Sr. Type of Responsible Frequency

Input Key Indicators Threshold values Actions
No. Analysis person of review
to maintain the
effectiveness of the
External Nasal Splint.
The Summary of Internal
and External Audits (if
any, occurred during the
annual year) is
considered while
conducting the PMS
activity to ensure
effectiveness of the
Overall System
performance. The
Internal audits are carried
out once in a year, while
the external audits
depend upon the
surveillance dates
accordingly the data is
maintained. The overall

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Product Name: External Nasal Splint Page 95 of 132

Sr. Type of Responsible Frequency

Input Key Indicators Threshold values Actions
No. Analysis person of review
results of the audit
provide opportunities for
improvement of the
quality system in EON
Meditech Pvt. Ltd.. It
may also lead into hiring
new people or resources.
The Summary and its
results with decided
action are fed into the
PMS Report
12. Communication with -- -- EON Meditech Pvt Ltd. – Director- As and
competent authorities, communicates with the Technical when
notified bodies, competent authorities, necessary
economic operators notified bodies, economic
and users operators and users as
and when required. If any
As per EU MDR issue regarding the
2017/745, Annex III product in scope –
Technical External Nasal Splint or

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Product Name: External Nasal Splint Page 96 of 132

Sr. Type of Responsible Frequency

Input Key Indicators Threshold values Actions
No. Analysis person of review
Documentation on
Post Market its submitted
Surveillance, Clause documentation is raised
1.1.b, indent 6 by any of these
Refer PROCEDURE authorities, EON
for Communication Meditech Pvt. Ltd. takes
with Regulatory Body immediate action to
(Document No.: - resolve it.
EMT-PM-24)
13. Benefit risk analysis of  Benefit Risk  Benefit Risk Annually, Risk Quantitative Director As and
Risk Management ratio ratio should not Management helps in Technical when
be less than 1 identification, necessary
As per EU MDR understand, control, and
2017/745, Annex III prevent failures that can
Technical result in hazards when
Documentation on customers use External
Post Market Nasal Splint and give
Surveillance, Clause conclusions of the
1.1.b, indent 3 benefit-risk
Refer PROCEDURE determination. Refer Risk

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Product Name: External Nasal Splint Page 97 of 132

Sr. Type of Responsible Frequency

Input Key Indicators Threshold values Actions
No. Analysis person of review
for Risk Management Management Report
(EMT-PM-25)
Purchase department in
EON Meditech Pvt. Ltd.
 0 major non- shall be in touch with our
Information from sub-  Number of
conformity sub-contractors /
contractors / suppliers major non-
obtained during suppliers to understand if
Refer PROCEDURE conformity
annual supplier there are any changes in
14. for Purchase and received Director
audit their procedures which Quantitative Yearly
Evaluation of Supplier during annual Technical
 Minimum 60% can affect our product
(Document supplier audit
score obtained conformity. The
No.:EMT-PM-07)  Supplier
during supplier Suppliers data are
evaluation
evaluation analysed yearly and the
conclusions are fed into
the PMS Report.
15. Information generated Monitoring the Quantitative Senior Monthly
during production and production process to Executive-
monitoring of the  Number of  Less than 5% ensure planned results are QA
production process rework rework process achieved and necessary
process done done on a corrections or corrective

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Product Name: External Nasal Splint Page 98 of 132

Sr. Type of Responsible Frequency

Input Key Indicators Threshold values Actions
No. Analysis person of review
As per EU MDR
2017/745, Annex III
Technical
Documentation on
on a product product actions taken when the
Post Market
 Number of  <5% rejected planned results are not
Surveillance, Clause
rejected products in a achieved are documented,
1.1.a, indent 1
products year analysed and reviewed.
Refer PROCEDURE
for Data Analysis
(Document
No.:EMT-PM-12)
16. Meta Information – – EON Meditech Pvt Ltd. – Director- Yearly
conducts thorough Marketing
Refer PROCEDURE analyses to identify any
for PMS (EMT-PM- trends or signals that
27) could indicate potential
issues with the device's
performance or safety.
Based on these analyses,
EON Meditech Pvt Ltd.

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Product Name: External Nasal Splint Page 99 of 132

Sr. Type of Responsible Frequency

Input Key Indicators Threshold values Actions
No. Analysis person of review
will take timely and
appropriate actions,
which may include
updating risk
assessments, modifying
the device design,
improving user training,
or communicating
findings to relevant
stakeholders.
17. Returned Product  Number of 0 returned products EON Meditech Pvt Ltd. Quantitative Technical As and
Returned in relation with will implement Director when
Refer PROCEDURE Products Safety and appropriate corrective necessary
for Procedure for Performance of the and preventive actions
Control of NC device (CAPA) to address the
Product Handling identified problems and
(Document No. – prevent recurrence.
EMT-PM-11) Additionally, EON
Meditech Pvt Ltd. will
communicate with

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Product Name: External Nasal Splint Page 100 of 132

Sr. Type of Responsible Frequency

Input Key Indicators Threshold values Actions
No. Analysis person of review
Refer PROCEDURE regulatory bodies and
for Advisory notice other stakeholders as
and procedure for required, providing
Product Recall detailed reports of the
(Document No.: findings and the steps
EMT-PM-05 & ) taken to resolve the issue.
Table 20. – Input Data for Post market surveillance
Refer Annex 7 > 7.2 PMSR of the TCF of External Nasal Splint
For Details of all Field Safety Corrective Actions: Refer Annex 7 > 7.2 PMSR of the TCF of External Nasal Splint
- Justification for Non-Applicability of PMCF
Annex 6>6.3 Post Market Clinical Follow-up >PMCF Justification of Non applicability
EON Meditech Pvt. Ltd. has decided not to carryout PMCF studies for External Nasal Splint in the scope by
referring statement mentioned as per the MEDDEV 2.12/2 Rev 2 guidelines. PMCF studies for all medical devices
in the scope is not required in which the safety and performance are known already from previous use of the device
and appropriately framed PMS activities provide enough data to identify the risks.
We, EON Meditech Pvt. Ltd. has justified not to conduct PMCF study for as it is based upon the clinical equivalence
which was well established in market and its long terms clinical safety and performance are already known.
External Nasal Splint (Manufactured by EON External Nasal Splint (Manufactured by
Meditech Pvt. Ltd.) Spiggle & Theis)
External Aluminium Nasal Splints External Aluminium Nasal Splint

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 Product Name: External Nasal Splint Page 101 of 132

External Thermoplastic Nasal Splints External Thermoplastic Nasal Splint

Table 21. – Device Manufactured by EON Meditech Pvt. Ltd. & Spiggle & Theis
The equivalence for these devices is performed based on:
- Same intended use, same contact site, similar patient population
- Similar design and similar specifications and properties
- Similar Principle of operation
Circumstances where PMCF Data is indicated
Circumstances that may
Sr. No Applicability Justification and Supporting Documents
Justify PMCF Studies
External Nasal Splint manufactured by EON Meditech Pvt. Ltd. have
an Equivalent device which are already in market more than 10 years
Innovation, e.g., where the
and CE certified. The Equivalent devices have same intended use,
design of the device, the
contact site, similar patient population, similar design and similar
materials, substances, the
1 Not Applicable specifications and properties, and similar principle of operation, as
principles of operation, the
there is no difference in material selection. There are no novel
technology or the medical
features for the device.
indications are novel;
Refer: Annex6 > 6.4 Clinical Evaluation > 6.4.4. Equivalent Device
Content
2 Significant changes to the Not Applicable EON Meditech Pvt. Ltd. has neither done any significant changes in
products or to its intended use the product design, material, component, characteristics, nor to its
for which pre-market clinical intended use. Our device is similar in design as well as intended use
evaluation and re-certification to existing external nasal splint. The equivalence to equivalent device

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Circumstances that may

Sr. No Applicability Justification and Supporting Documents
Justify PMCF Studies
is conformed in Clinical Evaluation Report. Safety and performance
of the device is assessed by review of literature as well as adverse
events reported of similar devices.
has been completed
Refer: Annex6 > 6.4 Clinical Evaluation > 6.4.4. Equivalent Device
Content
Annex 1 > 1.4 similar device report
An external nasal splint is a non-invasive device that does not come
in direct contact with the skin. There is no significant risk associated
with the use of an External Nasal Splint in the scope. We have
High product related risk e.g.,
identified all the risk related to design, Material, Components of
Based on design, materials,
3 Not Applicable device and reduced to ‘as far as possible’ level. Benefit Risk analysis
components, invasiveness,
is performed for all the risk, and any remaining risks for which
clinical procedures.
further control is not possible are mentioned in Instruction for Use.
Refer: Annex 5 > 5.3 Risk Management Report
Annex 2 > 2.2 Instruction for use (IFU)
4 Use of medical device in: Not Applicable External Nasal Splint is compatible and can applied to the Nasal
-Anatomical locations having Dorsum following self-adhesive tape, hence there are no high-risk
high risk - High risk target anatomical locations involved. The device is used for Adult and
populations Children. Children or Paediatrics, Geriatric is high-risk target

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Circumstances that may

Sr. No Applicability Justification and Supporting Documents
Justify PMCF Studies
Severity of disease / population.
treatment challenges
Severity of disease:
External Nasal Splint is required in case of Septoplasty, Rhinoplasty,
Septoplasty and nasal fracture for the patients who have dislocation
of nasal bones.
Although this procedure is considered as a safe procedure, there is
potential for both minor and major complications.

Treatment Challenges:
This procedure is practiced more than 30 years. It is a simple and safe
procedure.
According to the clinical evaluation of published literature,
demonstrated clinical safety and performance of the device for the
possible risk which are associated with the device such as localized
infection, scar formation, discomfort.

Refer: Annex 5 > 5.3 Risk Management Report

Annex 2 > 2.2 Instruction for use (IFU)

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Circumstances that may

Sr. No Applicability Justification and Supporting Documents
Justify PMCF Studies
Annex 6>6.4 Clinical Evaluation>6.4.6 Clinical Evaluation Report
External Nasal Splint in the scope already have an equivalent device;
hence no clinical investigations were conducted for the device. EON
Questions of ability to
Meditech Pvt. Ltd. will collect feedbacks and post market data for
5 generalize clinical Not Applicable
External Nasal Splint in the scope.
investigation results
Refer: Annex 7 >7.1 PMS Plan
Annex 7>7.2 PMSR Report
There is no new information on safety and performance emerged.
Safety and performance of EON external nasal splint is ensured by
conforming to applicable quality standards for manufacturing as well
as well as operational with respect to safety at every level.
Unanswered questions of Identification of risks associated with the use of the device by
6 long-term safety and Not Applicable regularly conducting Post Market Surveillance which includes
performance Vigilance data search – MAUDE, MHRA, Health Canada, ANVISA,
TGA, PMDA, review of literature, Customer complaints, any safety
action etc. and ensuring risk mitigation by implementation of action
where required.
Refer: Annex 7>7.2 PMS Report
7 Results from any previous Not Applicable No adverse event is reported for External Nasal Splint in the scope
clinical investigation, manufactured by EON Meditech Pvt. Ltd. However, we have

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Circumstances that may

Sr. No Applicability Justification and Supporting Documents
Justify PMCF Studies
conducted a vigilance data search from- MAUDE (United States),
including adverse events or
MHRA (United Kingdom), ANVISA (Brazil), Health Canada, TGA
from post-market surveillance
SARA(Australia) and PMDA (Japan).
activities
Refer: Annex 7>7.2 PMS Report
We have performed clinical evaluation (Annex 6>6.4 Clinical
Risks identified from the
Evaluation>6.4.6 Clinical Evaluation Report) External Nasal Splint
literature or other data
8 Applicable in the scope and the risk identified from the literatures are covered in
sources for similar marketed
the risk management report
devices;
Refer: Annex 5>5.3 Risk Management Report
External nasal splint does not come in contact with any medical
products/treatment, as they are used post-operatively. Also, it does
Interaction with other medical
9 Not Applicable not incorporate any medicinal substance.
products or treatments
The device does not have direct contact with the skin.
Refer: Annex 6 > 6.6 Declarations
10 Verification of safety and Not Applicable A vigilance database search is performed and we take corrective
performance of device when action against the reported events. Also, we conduct post market
exposed to a larger and more surveillance. The data obtained from PMS and vigilance data base
varied population of clinical will be utilized to update the risk management and clinical
users evaluation.

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Circumstances that may

Sr. No Applicability Justification and Supporting Documents
Justify PMCF Studies
Refer: Annex 7>7.2 PMS Report
Refer: Annex 5>5.3 Risk Management Report
Annex 6>6.4 Clinical Evaluation>6.4.6 Clinical Evaluation Report
Emergence of new
There is no emergence of any new information on safety or
11 information on safety or Not Applicable
performance of all medical devices in the scope.
performance
The CE marking is based on the Clinical equivalence. External Nasal
Splint in the scope is equivalent to CE marked products mentioned
above. (Refer Annex 6>6.4 Clinical Evaluation>6.4.6 Clinical
Evaluation Report). And we have PMS procedure (Refer Annex 3 >
Where CE marking was
12 Applicable 3.4 Procedures & Regulatory Strategy > PMS Procedures) in place
based on equivalence.
to gain data regarding the safety and performance of the concerned
device and equivalent device. Also, all the risks related to the life
cycle of the concerned device are identified, evaluated and mitigated
to as far as possible (Refer Annex 5 Risk Management File)
Table 22. – PMCF Justification Data
Post market surveillance is an integral part of the quality management system in EON Meditech Pvt. Ltd. Following data can be gained
from the PMS activity:
- Detection of manufacturing problems
- Product quality improvement

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- Confirmation (or otherwise) of risk analysis

- Knowledge of performance
- Knowledge of changing performance trends
- Knowledge of performance in different user populations
- Feedback on IFU
- Feedback on customer satisfaction
- Identification of vigilance reports
- Knowledge of ways in which the device is misused
- Feedback on continuing market viability’s
Conclusion
It is therefore proposed that EON Meditech Pvt. Ltd. will perform review of any customer complaints or adverse events data received
against these devices or data published on similar devices obtained during reviews conducted, as part of their routine post market
surveillance. This is in accordance with EON Meditech Pvt. Ltd. Quality Management Procedure for Post Market Surveillance. Since the
long-term safety and clinical performance are already known to provide sufficient data to address the risks, we conclude that PMCF
activity is not necessary to be carried out.
Relevant pre-clinical studies
Refer Annex 6 > 6.1 Pre-Clinical Testing of the TCF of External Nasal Splint)
● Data retrieved from literature: There are different sources of clinical literature that can be searched for clinical
evaluation.
- PubMed: (https://pubmed.ncbi.nlm.nih.gov/)
Pub-Med (US National Institutes of Health) is a recognized and respected web site for medical related articles on the
usage of medical devices.

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Justification for using PubMed:

PubMed comprises over 20 million citations for biomedical literature from MEDLINE, life science journals, and
online books. PubMed citations and abstracts include the fields of medicine, nursing, dentistry, veterinary medicine,
the health care system, and preclinical sciences. PubMed also provides access to additional relevant Web sites and
links to the other NCBI molecular biology resources. PubMed is a free resource that is developed and maintained by
the National Centre for Biotechnology Information (NCBI), at the U.S. National Library of Medicine (NLM),
located at the National Institutes of Health (NIH).
- Google Scholar: (https://scholar.google.com/)
Google Scholar provides a simple way to broadly search for scholarly literature. From one place, you can search
across many disciplines and sources: articles, theses, books, abstracts and court opinions, from academic publishers,
professional societies, online repositories, universities and other web sites. Google Scholar helps you find relevant
work across the world of scholarly research.
Justification for using Google Scholar:
- Search all scholarly literature from one convenient place,
- Explore related works, citations, authors, and publications,
- Locate the complete document through your library or on the web,
- Keep up with recent developments in any area of research,
- Check who's citing your publications, create a public author profile.
- Cochrane Library: (https://www.cochranelibrary.com/)
The Cochrane Library is a collection of databases in medicine and other healthcare specialties provided by Cochrane
and other organizations.
Justification for using Cochrane Library:

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At its core is the collection of Cochrane Reviews, a database of systematic reviews and meta-analyses, which
summarize and interpret the results of medical research.
- For the random searches the various general and special websites & search engine shall be used e.g., Google,
internet search, website of similar devices, Official website of FDA and for planned searches the following websites
will be used which act as databases / registers e.g.,
- Scientific databases – Bibliographic e.g., Medline, Embase
- Specialized Databases – MEDION
- Clinical Trial Register e.g., Central
- MAUDE (US FDA’s Manufacturer and User Facility Device Experience
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm)
- Official website of US FDA (US Food and Drug Administration
http://www.fda.gov/MedicalDevices/default.htm)
- MHRA (Medicines & Healthcare products Regulatory Agency
https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency)
- Pharmaceuticals and Medical Devices Agency - PMDA
- https://www.pmda.go.jp/english/
- Canada (Health Canada)
- http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/index-eng.php?cat=3
- Australia (Database of Adverse Event Notifications - medical devices: TGA DAEN)
https://apps.tga.gov.au/prod/DEVICES/daen-entry.aspx
- System for Australian Recall Actions: TGA SARA https://apps.tga.gov.au/PROD/SARA/arn-entry.aspx

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- Brazil (ANVISA) http://portal.anvisa.gov.br/alertas

- Future sources of information for the clinical safety & performance data collection:
- studies published via the EUDAMED clinical investigations module
- common specifications applicable to the device in question and containing information on clinical performance
and clinical safety
- Sources particularly with respect to SOTA evaluations:
- meta-analyses and reviews of health technology assessment (HTA) institutes and networks
- expert documents produced by professional medical associations
- harmonized standards and other standards applicable to the device in question and containing information on
clinical performance and clinical safety
36. Literature Search Strategy
(As per Appendix A5 “Literature search and literature review protocol, key elements” of MEDDEV 2.7/1 Rev.4)
The main purpose of literature search is to find out the devices equivalent/or similar to the concerned product and whose safety,
performance, indications, contraindications, precautions, warning etc. is proved in real world patients.
36.1 PICO Method
(As per section Appendix A5 “Literature search and literature review protocol, key elements” of MEDDEV 2.7/1 Rev.4)
PICO method will be used as a search strategy tool for literature search. The PICO tool focuses on the Population, Intervention,
Comparison and Outcomes of a (usually quantitative) article.
PICO is a mnemonic used to describe the four elements of a good clinical foreground question:
P = Population/Patient/Problem
I = Intervention
C = Comparison

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O = Outcome
Steps implemented to complete the PICO search are –
- Formulating the PICO question and identifying the keyword for PICO search
- Planning the search strategy and executing the search
- Refining the result and reviewing the literature
- Assessing the evidence
We have formulated the Questions and keywords for conducting the PICO search by following the above-mentioned steps.

Figure 7. – Steps Involved in PICO

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Search term used for appraisal

Total Search Terms 25
Search Term
PICO Questions Search Term
No.
"ALUMINIUM"
What is the Material "THERMOPLASTIC"
Comparison and
of construction of 1 "EXTERNAL SPLINT"
Control
device? "NASAL" "material"
"stabilisation"
Patient what is the intended (nasal bone fracture) AND
2
Problem use of the External (External nasal splint)
Or Nasal Splint? TRAUMA PROTECTION
Population "EXTERNAL NASAL SPLINT"
3
"TRAUMATIZING
ACTIVITIES"
(nasal trauma) AND (Patient)
4 AND (external splints) AND
(stabilize nasal fractures)
(External Nasal Splint) AND
5
(rhinoplasty) AND (nasal dorsum)
6 External nasal splint patient

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Total Search Terms 25

Search Term
PICO Questions Search Term
No.
population
Patient (External Nasal Splint) AND
7
Problem what is the target (Pediatric)
Or patient population? ((external nasal splint) AND (self-
8
Population adhesive)) AND (padded)
"external nasal splint" "short-
Patient 9 term" "duration" "postoperative
Is the external nasal
Problem period" "soft-tissue injury"
splint short-term
Or "external nasal splint" "longer
device?
Population 10 Period" "external splinting"
"postoperative"
external nasal splint
Is there any "thermoplastic splint" " nasal
11
precautions to be fracture" "external splinting"
Intervention taken to avoid direct "method"
contact of external "thermoplastic splint" hot water
nasal splint? 12 "nasal splinting" "prevent thermal
injury"
Outcome Does the device have 13 "External splint" for "prevent

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Total Search Terms 25

Search Term
PICO Questions Search Term
No.
swelling"
clinical benefit "External splints" "Perioperative
14
Treatment" "beneficial effects"
"external nasal splint" "Local
what are the adverse 15
Infection"
Outcome effects of external
"external nasal splint" "scar
nasal splints? 16
tissue" "serious complication"
"Sterilization Methods for
Is there any method
Medical Devices" "manufacturing
Intervention of sterilization of 17
industries" "Ethylene Oxide
medical devices?
(EtO)" "Gas sterilization"
"Traditional" method
What is the Historical
Control and "techniques" of "external nasal
perspective of 18
Comparison splint" "rhinoplasty" "cast" "nasal
device?
deformity"
Control and Is there any "Alternative treatment" for
19
Comparison alternative treatment rhinoplasty "external splint"
available for the 20 "Novel Method of Splinting"
medical condition

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Total Search Terms 25

Search Term
PICO Questions Search Term
No.

instead of External
Is there
nasal any
splint?
Control and equivalent are Spiggle & Theis Medizintechnik
21
Comparison available in the GmbH External splint
market?
22 "aluminum Denver splint"
Are there any similar
Control and SOFT-FORM™ EXTERNAL
devices are available
Comparison 23 THERMOPLASTIC SPLINT
in the market?
INVOTEC
Patient Applications instruction
24
Problem thermoplastic nasal splint
How to use device?
Or
25 External nasal splint denver splint
Population
Table 23. – Search term used for Appraisal
36.2 The Selection Criteria to be Applied on Published Literature
(As per Appendix A5.3 “Methods” of MEDDEV 2.7/1 Rev.4)
● Technically, Biologically & Clinically Equivalent to the concerned product.

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Justification: As the clinical evaluation of concerned product is based on published scientific literature of equivalent
device, the selected published literature should be equivalent to concerned production terms of Technical, Biological &
Clinical equivalence.
● The equivalent device must have to prove safety and efficacy in real world patients.
Justification: As the clinical evaluation of concerned product is based on published scientific literature of equivalent
device, it is necessary that equivalent have to prove safety and efficacy in real world patients.
● The similar device must have to prove current state of art, possible risk associated with the device, similar
indications, contraindications, precautions, adverse reaction in real world patient.
Justification: As the clinical evaluation of concerned product is based on published scientific literature of similar device,
it is necessary that similar device have to prove current state of art, possible risk associated with the device, similar
indications, contraindications, precautions, adverse reaction in real world patients.
36.3 The Data Collection Plan
(As per Appendix A5.3 “Methods” of MEDDEV 2.7/1 Rev.4)
After finalizing the search terms, the literatures are searched across the aforementioned search engines. All the literatures
generated are downloaded serially into an "ALL" folder and one particular serial number is assigned to that literature, in
consistent with the number assigned to the search term. (For e.g., For the literatures obtained using Search term 1, the
corresponding names given to the literatures obtained under shall be given as: 1.1, 1.2, 1.3, 1.4 etc.) After completion of
literature search, all literatures will be divided in 3 categories:
• Included Literatures
• Excluded Literatures
• Non-Published Literatures

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If the literatures match to the criteria for determining the relevance of clinical data to that of concerned product, as mentioned
in below section, those literatures shall be transferred from “ALL” folder to the folder of “Included literatures”.
If the literatures match to the criteria for exclusion mentioned, those literatures shall be transferred from “ALL” folder to the
folder of “Excluded literatures”.
If the literature is not a review/research article and it is not published in any journals, e.g., IFU of any equivalent
device/benchmark device, technical report related to the concerned products, surgical techniques/product catalogues of
equivalent devices, Safety Information Articles, Tutorial Data, articles that are published but are not scientifically validated
etc., such sources shall be included in the appraisal table and only Qualitative analysis should be performed for them.
After completion of all the literatures, extracted data shall be reviewed again by an additional reviewer of EON Meditech Pvt.
Ltd. who shall be a part of the clinical team.
Literature Search Criteria:
The types of studies that are relevant to these objectives are specified in the below mentioned inclusion and exclusion criteria
for the literature search:
Inclusion Criteria:
- Literature provides data on performance, risk and/or safety relevant to subject device or equivalent device or state-of-the-
art device
- Literature provides data relevant for the clinical evaluation of the equivalent device or state-of-the-art device
- Literature provides data on state-of-the-art devices used in way similar to indications for use of the subject device.
- Literature contains insufficient information to undertake a scientific analysis about device performance (due to poor trial
design or inadequate analysis) but provides safety information.
- Literature contains information related to the current knowledge/state of art technology/medical alternative technologies
and clinical background (History)

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- Literature contains information which help identifying relevant hazards/hazardous situations

- Literature contains information related to the clinical outcome parameters/outcomes
- Literature data demonstrating conformity with the relevant GSPR clauses (level of clinical evidence)
Exclusion Criteria:
- E1: Literature contains unsubstantiated opinions
- E2: Alternative/Unrelated Study Objective
- E3: Animal studies/Cadaver Studies
- E4: Hypothesis/Book chapters/Study Protocols/Thesis
- E5: Only Abstract, Result & Conclusion/Insufficient Information
- E6: Irrelevant title/study
- E7: Other languages
- E8: Duplicate Literature
- E9: In-vitro study/ in silico studies/ Biomechanical studies
37. Appraisal Plan
(As per Section 9 “Appraisal of Pertinent data (Stage 2)” & Appendix A6 “Appraisal of Clinical Data” of MEDDEV 2.7/1 Rev.4)
Comprehensive methods shall be utilized to identify and appraise all data sources that will be generated and held by EON Meditech
Pvt. Ltd. for the subject devices including evidence from Europe and other countries. The appraisal of each data source is described
below, with further details in subsequent sections for each data source.
For all data sources, suitability and contribution shall be determined by assessing whether the data are generated on the subject
device or other devices considered representative. More weightage will be given to data collected directly on the subject device. Data
will only be included if the reports contain sufficient information to be able to undertake a rationale and objective assessment.

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For non-clinical testing, the test methods/study designs will be assessed to ensure they are considered representative of the intended
use of the subject device and of the treatment population.
The data already available with EON Meditech Pvt. Ltd. for example, the post-market surveillance data, including complaints and
sales, Feedbacks, vigilance, CAPA; will provide valuable information towards the assessment of safety for the subject devices and
reflects real world usage. While the follow-up times and clinical use of the devices relative to the intended purpose cannot easily be
ascertained, the data obtained are representative of the treated population and are of sufficient quality to allow a rationale and
objective assessment.
Risk management data including identified clinical risks, benefits, and the information provided to the user on residual risks will be
evaluated in comparison to the other data sources to determine the acceptability of the known side effects and benefit-risk ratio.
37.1 Relevance of Data/Literature Selection Process
The relevance of data and the extent to which the scientific articles related to the device in question and the other objectives of
this search are shown and discussed. The appraisal criteria are given in Tables 24 to 28. The criteria will be applied to each
clinical study in sequence and weightage will be assigned for each dataset accordingly. The criteria listed below are based
around the sorts of issues that could be considered for devices of higher risk, such as characteristics of the sample, methods of
assessing the outcomes, the completeness and duration of follow-up, as well as the statistical and clinical significance of any
results.
37.2 Appraisal Criteria for Suitability
In order to appraise the data retrieved from the literature search, all included papers will be assessed according to predefined
weighting factors as detailed in the tables below;
Study Type Score
Prospective Clinical Study 20
Retrospective Clinical Analysis 15

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Case Study 10
Research Article 10
Comparative Study 10
Questionnaire or Survey 5
Review Paper 5
Observational study 5
Not Specified 5
Guideline 5
Table 24. Study Type
Medical Device Type Score
Actual Device 20
Equivalent Device 15
State-of-the-Art Device 10
Other Device 5
Table 25. Medical Device Type

Study Size Score

Greater than or equal to 50 20

Between 21 to 49 15

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Less than or equal to 20 10

Not Specified - 5
Table 26. Study Size
Acceptability of Data Collation Score
High Quality 20
Minor Deficiency 15
Insufficient Data 05
Table 27. Acceptability of Data Collation

Follow up period Scor

(Years "Y", Months "M", Days "D") e
(Write: "Number","space","y/m/d)
Greater than or equal to 30 d 20
Between 16 to 29 d 15
Less than or equal to 10 d 10

Not Specified 5
Table 28. Follow up period
The resultant score will provide an indication of the strength and relevance of the data retrieved, which in turn will be used to identify
how relevant the data is in accordance with the table below

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Score (Out of 100) Relevance Definition

This literature provides a major contribution to this clinical
85 Pivotal
evaluation and is of excellent overall quality.
This literature provides an important contribution to this clinical
55 and < 85 Important
evaluation and is of very good overall quality.
This literature provides a useful contribution to this clinical
< 55 Useful
evaluation and is of acceptable overall quality
Table 29: Appraisal Criteria for data (For Qualitative Assessment of clinical safety & performance claims/requirements)

Appraisal Criteria for data (For Qualitative Assessment of clinical safety & performance claims/requirements)
Data Contribution
Description Grading System
Criteria
T1 Yes
Data Source Type Was the design of the study appropriate?
T2 No

O1 Yes
Does the outcome measures reported reflect the
Outcome Measures
intended performance of the device?
02 No

Is the duration of follow-up long enough to assess F1 Yes

Follow up whether duration of treatment effects and identify
complications? F2 No

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Data Contribution
Description Grading System
Criteria

Has a statistical analysis of the data been provided S1 Yes

Statistical Significance
and is it appropriate? S2 No

Was the magnitude of the treatment effect C1 Yes

Clinical Significance
observed clinically significant? C2 No

Table 30: Appraisal Criteria for data (For Qualitative Assessment of clinical safety & performance claims/requirements)
38. Level of Evidence (FOR QUALITATIVE ASSESSMENT OF CLINICAL SAFETY & PERFORMANCE
CLAIMS/REQUIREMENTS):
For clinical data from scientific literature, the data were appraised using the Oxford Centre for Evidence Based Medicine (OCEBM)
Levels of Evidence. The level of evidence for each citation was assessed and higher levels (randomized controlled clinical trials, for
example) are given more weight towards overall conclusions and assessment of safety and performance when compared against
lower-level cohort or case reports. Nevertheless, even case reports reflect real-world usage of the subject device. Follow-up times,
population characteristics, and device usage (compared against intended purpose) are all appraised and factor into the presentation
and weight of the data.
The level of evidence provides an overview of performance data and indicates the study design used to assess the effectiveness of an
intervention. The level assigned to a study reflects the degree to which bias has been eliminated by the study design. Table below
designates the levels of evidence used to assess the references selected based on the inclusion criteria.
Level Description

Level 1 Systematic meta-analysis of randomized controlled trials (RTC)

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Level 2 Randomized controlled trials (RTC)

Level 3 Non-Randomized pro/retrospective cohort follow up studies
Research Paper, Case series or case report, case-control or historically
Level 4
controlled studies, Comparative study
Level 5 Expert opinion/ mechanism-based reasoning/technical note / Review paper
Level L Guidelines, Non-clinical publications and laboratory studies
Table 31: Level of Evidence
39. The Criteria to Check the Quality & Scientific Validity of Each Data
(As per Section 9.3.1. “How to evaluate methodological quality and scientific validity” of MEDDEV 2.7/1 Rev. 4)
The data is considered of appropriate quality if it is proving the safety of the device and is retrieved from authentic, approved
sources. The data is considered as scientifically valid if it is published by manufacturer itself or by the manufacturer of equivalent
device or if it is published by authors, who have in depth knowledge of the subject, like specialized Physicians, Doctors and Health
care-takers. Further the clinical data should be either of the concerned product or of equivalent device.
40. The Criteria for Determining the Relevance of Clinical Data to that of Concerned Product
(As per Section 9.3.2. “How to determine the relevance of a data set for the clinical evaluation” of MEDDEV 2.7/1 Rev. 4)
The table below shows the aspects that could be used for determining if and in what respect data are relevant to the clinical
evaluation.
Description Examples
To what extent are the data generated - device under evaluation
representative of the device under - equivalent device
evaluation? - other devices and medical alternatives

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Description Examples
- data concerning the medical conditions that are
managed with the device

What aspects are covered? - pivotal performance data

- pivotal safety data
- claims
- identification of hazards
- estimation and management of risks
- establishment of current knowledge/ the state of
the art
- determination and justification of criteria for
the evaluation of the risk/benefit relationship
- determination and justification of criteria for
the evaluation of acceptability of undesirable
side-effects
- determination of equivalence

Are the data relevant to the intended - representative of the entire intended purpose
purpose of the device or to claims about with all patient populations and all claims
the device? foreseen for the device under evaluation
- concerns specific models/ sizes/ settings, or

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Description Examples
concerns specific aspects of the intended
purpose or of claims
- does not concern the intended purpose or
claims

Used on - All Patient Population.

User group - Health Care Professionals

- Otorhinolaryngologists

Table 32: Criteria for Determining the Relevance of Clinical Data to that of Concerned Product
41. Analysis of the Clinical Data
(As per Section 10 “Analysis of the Clinical Data (Stage 3)” & Appendix A7 “Analysis of the Clinical data” of MEDDEV 2.7/1
Rev.4)
Analysis of Clinical Data shall be conducted to determine that appraised data of concerned products is complying with all general
safety and performance requirements, design characteristics, clinical benefits to the patients of the device, requirements pertaining to
the clinical benefits to the patients of the devices, when the device is used according to its intended purpose.
42. COMPLIANCE TO THE GENERAL SAFETY AND PERFORMANCE REQUIREMENT
(As per Appendix A7 “Analysis of the Clinical data-compliance to specific essential requirements” of MEDDEV 2.7/1 Rev.4)
(As per Appendix II – Clinical Evaluation Plan for Legacy Devices of MDCG 2020-6)

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We have demonstrated the compliances to all applicable GSPR using harmonized, common specification and non-harmonized
standards as well as applicable EU guidelines. We have ensured that all applicable requirements are compiled using applicable
standards.
The relevant General Safety & Performance Requirements of Annex I to EU-MDR 2017/745 are applied & complied as far as safety
and performance-related device features are concerned.
All applicable clauses are complied with on the basis of the clinical safety and performance data identified in the Clinical evaluation
through the literature search, furthermore on the basis of Risk management, IFU, Usability Engineering, Pre-Clinical testing and Post
market Surveillance.
GSPR1, GSPR2, GSPR3, GSPR4, GSPR5, GSPR6, GSPR7, GSPR8, GSPR10.1, GSPR10.1a, GSPR10.1b, GSPR10.1d, GSPR10.1f,
GSPR10.1g, GSPR10.1h, GSPR10.2, GSPR10.5, GSPR11.1, GSPR11.1a, GSPR11.1b, GSPR11.1c, GSPR11.1d, GSPR11.3,
GSPR11.4, GSPR11.5, GSPR11.6, GSPR11.7, GSPR11.8, GSPR14.2a, GSPR14.2b, GSPR14.2c, GSPR14.2e, GSPR14.7,
GSPR20.1, GSPR23.1, GSPR23.1a, GSPR23.1b, GSPR23.1c, GSPR23.1d, GSPR23.1g, GSPR23.1h, GSPR23.2a, GSPR23.2b,
GSPR23.2c, GSPR23.2d, GSPR23.2g, GSPR23.2h, GSPR23.2i, GSPR23.2j, GSPR23.2k, GSPR23.2l, GSPR23.2m, GSPR23.2n,
GSPR23.2q, GSPR23.3a, GSPR23.3b, GSPR23.3c, GSPR23.3d, GSPR23.3e, GSPR23.3h, GSPR23.3i, GSPR23.3j, GSPR23.4a,
GSPR23.4b, GSPR23.4c, GSPR23.4e, GSPR23.4g, GSPR23.4h, GSPR23.4i, GSPR23.4j, GSPR23.4l, GSPR23.4m, GSPR23.4p,
GSPR23.4s, GSPR23.4v, GSPR23.4y, GSPR23.4z.
The above-mentioned General Safety & Performance Requirements have been complied with on the basis of the clinical safety and
performance data identified in the Clinical evaluation through the literature search, further more on the basis of Risk management,
IFU, Usability Engineering, Pre-Clinical testing and Post market Surveillance.
Correct rationales are provided wherever the requirements are not applicable for our device.
Refer Annex 4 > 4.2 GSPR of the TCF of External Nasal Splint

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43. Custom Made Device

The concerned device is not a custom-made device
44. Use Under Compassionate Use/ Humanitarian Exemption Programs
The concerned device is not use under compassionate use/ humanitarian exemption program.
45. Data Mapping, Conclusions & Benefit – Risk Valuation
Once the data is appraised, EON Meditech Pvt. Ltd. shall map it against the relevant outcomes parameters and benchmarks
identified through the cycle of SOTA evaluation and this clinical evaluation planning. EON Meditech Pvt. Ltd., shall ensure
that the data is appropriately stratified and the necessary conclusions are drawn on safety, performance and benefit-risk for
the device in scope considering its variants, combination details, medical indications and patient populations, and the safety
and performance/clinical benefits claims specified by EON Meditech Pvt. Ltd. If the benchmark set in this clinical evaluation
plan is not met for the device in scope by the SOTA evaluation for one or more outcome parameters mentioned in the section
28 of this clinical evaluation plan, such discrepancy needs to be addressed in the Clinical Evaluation Report of the device by
–
- narrowing the scope or indications to those for which the benchmarks for clinical safety, performance and benefit
parameters have been clearly met
- providing justifications for the applicability of other data sources to strengthen conclusions (e.g., potential applicability
of data for one patient population to another population, additional equivalence routes, or cumulative clinical and non-
clinical evidence
- providing a quantification of benefit-risk (e.g., to demonstrate that a risk reduction is so great as to outweigh a small
reduction in benefit, or considerations relating to unmet needs and the risk to the patient of not having a given treatment
option available)
- Summary & Conclusion shall be recorded in Clinical Evaluation Report of the device in scope.

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46. Any New Change Introduced by the Manufacturer

The concerned product is based on long-standing, well-established technology. No changes in product design or
manufacturing process have been reported till date. The manufacturer does not intend to include any innovative features in
the available product design and hence the claim of equivalence to an existing device is appropriate.
47. Any Specific Clinical Concerns that have Newly Emerged and Need to be Addressed)
(As per Appendix A5.3 “Methods” & Section 8.2 “Data retrieved from literature” of MEDDEV 2.7/1 Rev.4)
There are no newly emerged clinical concerns that need to be addressed. The concerned product is based on long-standing, well-
established technology. No changes in product design or manufacturing processes have been done till date. We do not intend to
include any innovative features in the available product design and hence the claim of equivalence to an existing device is
appropriate. EON Meditech Pvt. Ltd. has made changes in the Instruction for use to provide detailed description of product usage
and to cover all the requirements as per ISO 20417:2021.
48. Frequency of Update
(As per Section 6.2.3 “Updating the Clinical Evaluation” of MEDDEV 2.7/1 Rev.4)
The Clinical Evaluation shall be reviewed & updated (if required) annually or the device carries any risk related with design,
material, components, invasiveness, clinical procedures, any new information is received from PMS, feedback/complaints, any recall
or adverse event that has potential to change the current evaluation; whichever is earlier.

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49. Amendment History

Sr. No. Issue No. Rev. No. Revision Date Description of Change Approval Authority

1. 03 00 25/07/2024 Initial Issue Managing Director

1. Standards related to
labelling (ISO
7010:2019/Amd
6:2022 & EN
01 15986:2011) are
2. 03 01-10-2024 Managing Director
removed from the
reference section.
2. Basic UDI-DI is
added

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