MDR

 Device Classification
 Conformity Assessment
 Safety & Performance Requirements
 Technical Documentation

Suzanne Halliday, D.Phil.

Jaishankar Kutty, Ph.D.
Ronald Rakos, Ph.D
BSI Roadshow, October 2017

1
Agenda

• Classification rules – Annex VIII

• Conformity Assessment – Annex IX to Annex XI

• General Safety and Performance – Annex I

• Technical File Documentation – Annex II

• PMS and PMS Technical Documentation – Annex III

2
MDR Classification
Annex VIII

3
MDR - Definitions
Term MDR MDD Delta
an invasive device which penetrates inside the body clarification that surgically
through the surface of the body, including through An invasive device which penetrates inside the body invasive also includes
Surgically Invasive
mucous membranes of body orifices with the aid or in through the surface of the body, with the aid or in penetration through
Device
the context of a surgical operation; (Annex VIII) the context of a surgical operation. mucous membranes of
body orifices
means an area of skin or a mucous membrane introduced definition for
Injured skin or
presenting a pathological change or change following n/a injured skin or mucous
mucous membrane
disease or a wound. membrane
Covered under Article 2 Any medical device operation of which depends on a
‘active device’ means any device, the operation of which source of electrical energy or any source of power
depends on a source of energy other than that other than that directly generated by the human Device which acts by
generated by the human body for that purpose, or by body or gravity and which acts by converting this changing the density of
gravity, and which acts by changing the density of or energy. Medical devices intended to transmit energy, energy are also considered
Active device
converting that energy. Devices intended to transmit substances or other elements between an active active devices. This is
energy, substances or other elements between an active medical device and the patient, without any considered a clarification
device and the patient, without any significant change, significant change, are not considered to be active only
shall not be deemed to be active devices. Software shall medical devices. Stand alone software is considered
also be deemed to be an active device; to be an active medical device.
Instrument intended for surgical use in cutting, drilling,
Instrument intended for surgical use by cutting,
sawing, scratching, scraping, clamping, retracting,
drilling, sawing, scratching, scraping, clamping, devices which can be re-
clipping or similar procedures, without a connection to
Reusable surgical retracting, clipping or similar procedures, without used vs intended by the
an active device and which is intended by the
instrument connection to any active medical device and which manufacturer to be reused;
manufacturer to be reused after appropriate procedures
can be reused after appropriate procedures have mostly a clarification
such as cleaning, disinfection and sterilisation have been
been carried out.
carried out.

4
MDR – Definitions & Implementing Rules
Term MDR MDD Delta
concept of continuous use
(a) the entire duration of use of the same device
extended to include
without regard to temporary interruption of use during a
means ‘an uninterrupted actual use of the device for devices that may be
procedure or temporary removal for purposes such as
the intended purpose’. temporarily removed to be
cleaning or disinfection of the device. Whether the
However where usage of a device is discontinued in cleaned or disinfected and
interruption of use or the removal is temporary shall be
Continuous use order for the device to be replaced immediately by then re-used; However this
established in relation to the duration of the use prior to
the same or an identical device this shall be is still considered a
and after the period when the use is interrupted or the
considered an extension of the continuous use of the clarification since such use
device removed; and (b) the accumulated use of a
device would be treated as
device that is intended by the manufacturer to be
'continuous use' under the
replaced immediately with another of the same type.
Directive as well
A device is considered to allow direct diagnosis when it
provides the diagnosis of the disease or condition in
Direct diagnosis n/a new definition
question by itself or when it provides decisive
information for the diagnosis.
Covered under Article 2.5
‘implantable device’ means any device, including those Any device which is intended:
that are partially or wholly absorbed, which is intended: — to be totally introduced into the human body or,
— to be totally introduced into the human body, or — to — to replace an epithelial surface or the surface of
Devices that are partially or
replace an epithelial surface or the surface of the eye, the eye, by surgical intervention which is intended to
wholly absorbed are
by clinical intervention and which is intended to remain remain in place after the procedure.
Implantable device considered implantable;
in place after the procedure. Any device intended to be partially introduced into
'Clinical' intervention vs
Any device intended to be partially introduced into the the human body through surgical intervention and
'surgical' intervention
human body by clinical intervention and intended to intended to remain in place after the procedure for
remain in place after the procedure for at least 30 days at least 30 days is also considered an implantable
shall also be deemed to be an implantable device; device.
5
Classification Rules – MDR, Annex VIII

MDR MDD
Rules 1 – 4: Non-invasive devices Rules 1 – 4 : Non-invasive devices

Rules 5 – 8 : Invasive devices Rules 5 – 8 : Invasive devices

Rules 9 – 13 : Active Devices Rules 9 – 12 : Active devices

Rules 14 – 22 : Special rules Rules 13 – 18 : Special rules

6
Rules 1 - 4: Non-invasive devices (in comparison with MDD)
Rule 1 Rule 2 Rule 3 Rule 4
• No change • Addition of “cells • Addition of human • Addition of injured
and tissues” to the tissues and cells to mucous
existing language blood, body liquids membrane to
and other liquids injured skin
• Blood bags moved
to MDR Rule 2 • Intended for • Replacement of
from Rule 18 of implantation or ‘wounds’ with
MDD administration vs injuries to skin
Intended for
infusion in MDD • Also covers
invasive devices
• Inclusion of organ that come into
storage solutions, contact with
IVF media into the injured mucous
rule which are membrane
class III

7
Rules 5 – 8: Invasive devices (in comparison with MDD/AIMD)
Rule 5 Rule 6 Rule 7 Rule 8
• No change – • All devices • All devices • AIMD devices and
clarifications only intended intended accessories are class
specifically for specifically for III
direct contact with direct contact with • Breast implants and
heart or central heart or central surgical meshes are
circulatory system circulatory system class III
now class III now class III
similar to devices similar to devices • Total and partial
in contact with in contact with joint replacements
central nervous central nervous are class III
system system
• Spinal disc
replacement
implants or
implantable devices
that come into
contact with spinal
column are class III
with some
exceptions (screws,
wedges, plates and
instruments)

8
Rules 9 – 13: Active Devices (in comparison with MDD/AIMD)
Rule 9 Rule 10 Rule 11 Rule 12
• Addition of active • Addition of • New rule on • Rule 11 in MDD
devices intended to ‘monitoring’ to software
emit ionizing radiation diagnosis; • No change
for therapeutic • Classifications
purposes, including
devices which control • Active devices range from class
or monitor such intended for III – class I
devices, or which diagnosis in
directly influence their clinical situations
performance, are where the patient
classified as class IIb. is in immediate
danger as class
• Addition of active IIb Rule 13
devices that are
intended for • Rule 12 in MDD
controlling, monitoring
or directly influencing • No change
the performance of
active implantable
devices are classified
as class III.

9
Rules 14 – 18: Special rules

Rule 14 Rule 15 Rule 16 Rule 17 Rule 18

(Devices with (Contraceptive (Disinfectants, (Devices for (Devices utilizing
medicinal devices, Devices sterilizers) recording x-ray human or animal
substances) for prevention of diagnostic images) derivatives)
transmission of
STDs)

• Rule 13 in MDD • Rule 14 in MDD • Rule 15 in MDD • Rule 16 in MDD • Rule 17 in MDD

• Addition of cells (to

• Clarification that • No change • Addition of • No change –
tissues)
medicinal product sterilisers to language clarified
can be derived disinfectants • Addition of human
from human blood origin cells and tissues
or plasma • Disinfectants or or derivatives
sterilisers become
• “Liable to act” IIb only if they • The exception about
taken out are used for contact with intact
invasive devices skin only, applies only
and as the end to animal tissue and
point of does not apply to
processing human tissues or cells

10
Rules 19 – 22: Special rules

Rule 19 Rule 20 Rule 21 Rule 22

(Devices incorporating (Body-orifice invasive (Devices consisting of (Active therapeutic
or consisting of devices intended to substances and device with an
nanomaterials) administer medicines by introduced into the integrated or
inhalation) body via body orifice or incorporated diagnostic
skin and that are function)
absorbed by or locally
dispersed)

• New rule • New rule • New rule • New rule

• Classifications from III • Classification IIa or IIb • Classification from IIa to • Class III
to IIa based on potential III based on where they
for internal exposure • IIb if they impact the are used and whether • Only applies if such
safety and performance they or their products of devices significantly
of the medicine or metabolism are determine the patient
intended to treat life- absorbed management
threatening conditions
• Closed loop systems or
automated external
defibrillators

11
Conformity Assessment Procedures
Annex IX, X, XI

12
Classification & Conformity Assessment – MDD

Class III
Competent Authority Assessment
Class IIb

Notified Body Conformity Assessment

Risk

Class IIa
Class Im /Is

Self-Certification
Class I
Custom Made
13
13
Classification & Conformity Assessment – MDR
Class III Implants
Class IIb active – administer
medicine
Commission Assessment
Class III
Class IIb Implants
Competent Authority Assessment Class IIb

Risk
Notified Body Conformity Assessment
Class IIa Class III Custom Made
Class Im /Is Implants

Class Ir
Self-Certification Class I
Custom Made
14
14
15

Regulation EU 2017/745 – Conformity Assessment

Unannounced Audit

Clinical Evaluation

Procedure (CECP)

SSCP (Article 32)

PSUR (Article 86)
Documentation

EC/726/2004
Management

EU 722/2012
Microbiology

Consultation

2001/83/EC

2004/23/EC
(Article 54)

(*Annual)
Technical
System
Quality
Class III Implants     5 years   * 

Class III     5 years  * 

Class IIb Active intended to administer and/or remove    sample  5 years  * not
medicines from the body per group submitted to NB

Class IIb Implants     5 years * 

Sutures, staples, dental fillings, dental braces, tooth    sample  5 years  

crowns, screws, wedges, plates, wires, pins clips connectors per group

Class IIb    sample  5 years * not

per group submitted to NB

Class IIa    sample  5 years  not

per category submitted to NB

15
16

Regulation EU 2017/745 – Conformity Assessment

(CECP) (Article
Documentation

Unannounced

PSUR (Article
EC/726/2004

SSCP (Article
Management

EU 722/2012
Microbiology

Consultation

2001/83/EC

2004/23/EC
Evaluation

Procedure

(*Annual)
Technical
System
Quality

Clinical
Audit

54)

86)

32)
Class I

Class Is, Im, Ir  

Class III Custom Made Implants    5 years * not

submitted to NB

Custom Made

Procedure Packs (Article 22)   5 years

Suppliers, Subcontractors  *depends on  *depends on  5 years

certification held certification held

EU Authorised Representatives, *impact sterile *impact sterile  5 years

Importers, Distributors (Article 16) barrier, translate, barrier, translate,
repackage repackage

16
General Safety & Performance
Requirements
Annex I

17
 General Safety & Performance Requirements (Annex I)

MDD 93/42/EEC: 13 Essential requirements

MDR 2017/745:
23 General Safety &
Performance
Requirements
AIMDD 90/385/EEC: 16 Essential requirements

• Similar to “Essential Requirements” in Directives.

̵ Similar content and topics
̵ Some numbering and organizational changes
̵ Expanded requirements (Labeling, Risk)
̵ New areas of emphasis (from standards and guidances, etc.)
̵ Some additional requirements because of merging of MDD with AIMDD
̵ Some topics move out of the SPR list into Articles/Annexes (Clinical, medicinal
consultation)
̵ Some new topics introduced (devices without medical purpose, lay person use, etc.) 18
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 Annex I: Safety and Performance Requirements

Chapter 3:
Chapter 1: Chapter 2: Information
General Design and Supplied with
Requirements Manufacture the Device
(SPRs 1-9) (SPRs 10-22) (SPR 23)

19
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 Annex I: Safety and Performance Requirements

Chapter 3:
Chapter 1: Chapter 2: Information
General Design and Supplied with
Requirements Manufacture the Device
(SPRs 1-9) (SPRs 10-22) (SPR 23)

• 1:Similar to ER 1 with additional emphasis on

risk/benefit and “state-of-the-art”
• 2-5: Much greater emphasis on risk management
• 9: New requirement for devices without a medical
purpose 20
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 Annex I: Safety and Performance Requirements
20: Much more detail on
22: New requirement: mechanical and thermal risks
10: Much more detail regarding Devices for lay person users
chemical, physical and biological Mitigate risks of fitting/refitting
properties, toxicology. and specific parts by design
substances of concern.
16-18: Active and AIMD, many
Chapter
similar 3: some new:
or identical,
Chapter 1: Chapter 2:
•Information
Increased emphasis on cyber
General Design and Supplied
security with
11: More requirements for
Requirements
infection and microbial
Manufacture MoreDevice
• the emphasis on ionising
contamination(SPRs 1-9) (SPRs 10-22) radiation/”electromagnetic
(SPR 23)
interference”
• Requirements from ISO 60601

12: Medicinal substances

scope expanded to include 14: More requirements for
substances that are absorbed • 13: Biological tissues expanded interaction with the
by or locally dispersed in the to include human tissues (non- environment and compatibility
human body viable) Also includes catch-all for with other devices, including
non-viable biological substances ergonomics, calibration,
of neither human nor animal disposal
21
origin
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 Annex I: Safety and Performance Requirements
23.1: More “general” requirements (e.g.
• Many clarifications on labelling requirements. format, readability, “understood”, availability,
• 23.2: Additional requirements for UDI, devices eIFU, lay person etc.), “residual risks”
incorporating human or animal tissues, medicines,
absorbable devices, “is it a MD” & others
• 23.3: Specific requirements for labelling on sterile
packagingChapter 1: Chapter 3:
Chapter 2: Information
• Indication if carcinogenic/mutagenic/toxic (CMR)
substances General Design and Supplied with
Requirements Manufacture the Device
(SPRs 1-9) (SPRs 10-22) (SPR 23)
23.4: Many new IFU requirements and cross-referencing to
articles, including (among others):
• Installation verification, PM, calibration, identification of
consumable components and how to replace (23.4k)
• Many more specific warning requirements (EMC, medicinal
substances, human or animal tissues, CMR and endocrine Labeling requirements have changed
disruptors) (23.4s) and expanded significantly
• Absorbable/dispersible materials (23.4t)
• Information on materials for implants (23.4u)
• Information security measures (23.4ab)
22
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Technical Documentation
Annex II

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Annex II

Technical Documentation

“The technical documentation and, if applicable, the summary thereof to be drawn

up by the manufacturer shall be presented in a clear, organised, readily
searchable and unambiguous manner…..”

Key Change: The MDR is very prescriptive regarding the Technical Documentation content
and formatting.

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Annex II Technical Documentation

Technical Documentation requirements are subdivided into the following 6 sections:

1. Device description and specification, including variants and accessories

2. Information to be supplied by the manufacturer

3. Design and manufacturing information

4. General safety and performance requirements

5. Benefit-risk analysis and risk management

6. Product verification and validation

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Annex II 1. Device description and specification, including variants and accessories
• Product name, description, intended purpose, intended users
• Basic UDI-DI or other unambiguous reference (product code, catalogue number etc.)
• Intended population, indications, contraindications, warnings
• Principle of operation of the device and mode of action; scientifically demonstrated…
• Rationale for considering the product a medical device
• Device classification, applicable rules & rationale
• Explanation of any novel features
• Description of accessories provided with or without the device
• Description of all the relevant variants of the device… sizes, shapes, material thicknesses, etc.
• Device pictures, relevant drawings
• Description of all the relevant raw materials along with a risk assessment from biological safety perspective
• Technical specifications, dimensions & performance attributes
• Reference & overview of previous and similar generations of the subject device and device market history
• Discussion of medicinal therapies used in conjunction with procedure

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Annex II 2. Information to be supplied by the manufacturer (SPR 23)
A complete set of:

• the label or labels on the device and on its packaging and the instructions for use in the languages accepted in the
Member States where the device is to be sold

• Promotional materials (Article 20)

• Implant Card (Article 18, SPR 23.4 aa)

• Summary of safety and clinical performance (SSCP, Article 32)

Annex II 3. Design and manufacturing information

• Information to allow the design stages applied to the device to be understood

• Complete information and specifications, including the manufacturing processes and their validation, their adjuvants, the
continuous monitoring and the final product testing. Data shall be fully included in the technical documentation
Note: ISO 13485:2016 requires design validation to be conducted on representative product (e.g., sterile finished devices).

• Identification of all sites including suppliers and subcontractors; where design and manufacturing activities are performed

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Annex II 4. General safety and performance requirements

• Documentation shall contain information to demonstrate conformity to general safety and performance
requirements (GSPR or SPRs) that are applicable (Annex I) taking into account its intended purpose and
shall include methods used to demonstrate conformity (justification, validation and verification).

• Demonstration
SPR ofApplicability
conformation shall include:
Standard or CS Demonstration/ Location
testing
 GSPRs that apply… explanation of why any GSPR does not apply;
(justification, (Precise identity)
 Method(s) used to demonstrate conformity… validation and
verification)
 Harmonised standards, CS or other solutions applied and
X
 The precise identity of the controlled documents offering evidence of conformity… Harmonised
Y
Standard, CS or method(s) [including] a cross-reference to the location of such evidence within
Z
the full technical documentation…

Have to clearly show/demonstrate how each SPR is met/satisfied.

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Annex II 5. Benefit-risk analysis and risk management

The documentation shall contain information on:

• The benefit-risk analysis (Annex I, Section 1 and 8)

• The solutions adopted and the results of the risk management referred to in Section 3 of Annex I (SPR 3)

SPR 3 is essentially a summary of the requirements of EN ISO 14971:2012

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29
Annex II 6. Product verification and validation
The documentation shall contain the results and critical analyses of all verifications and validation tests and/or studies undertaken to
demonstrate conformity with the requirements of the MDR and in particular the applicable SPRs

Pre-Clinical and Clinical data

• In Vitro & In Vivo test outcomes, simulated use testing, evaluation of the published literature and overall discussion of preclinical
safety in combination with conformance with specifications
• Detailed discussion of test design, test protocols and reports with data analysis and conclusions in particular for the following:
• biocompatibility (Annex I, SPR 10)
• physical, chemical and microbiological characterization (Annex I, SPR 10 and 11)
• electrical safety and electromagnetic compatibility (Annex I, SPR 18, AIMD: SPR 19)
• software verification and validation (Annex I, SPR 17)
• stability, including shelf life (Annex I, SPR 7)
• performance and safety (Annex I, SPR 1 and 6)
Where applicable conformity to Directive 2004/10/EC (GLP Directive) must be demonstrated (for devices containing medicinal
substances)
Where no new testing has been conducted the documentation shall incorporate a rationale for that decision
• Very prescriptive requirements with links to SPRs and CER; evaluation of the published literature with respect to pre-clinical testing
• Clinical evaluation plan and report (along with updates) per Article 61(12) [CER] and Part A of Annex XIV (detailed
description of CER)
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Annex II 6. Product verification and validation

Additional information for specific cases:

• Medicinal substances requirements per Directive 2001/83/EC (Annex I, SPR 12)

• Requirements for devices utilizing tissues or cells of human or animal origin or their derivatives (Annex I, SPR 13)

• Devices composed of substances or combinations thereof intended to be introduced into the human body that are absorbed
by or locally dispersed (Annex I, SPR 12)

• Carcinogenic, mutagenic or toxic to reproduction (CMR) and endocrine-disrupting substances (Annex I, SPR 10.4)

• Sterility and microbiological condition (Annex I, SPR 11)

• Measuring Function (Annex I, SPR 15)

• Devices connected to other devices, description and compliance with SPR (Annex I, SPR 14)

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31
Technical Documentation on
Post-Market Surveillance
Annex III
and overview of MDR PMS requirements

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Article 2, Definition 61
QMS Current MDD Requirements

‘Post-Market Surveillance’
PMS
all activities carried out by the
manufacturer in cooperation with other
Vigilance
economic operators to institute and keep
up to date a systematic procedure to
Reactive PMS
proactively collect and review experience
gained from their devices placed on the
Proactive PMS
market, made available on the market or
put into service for the purpose of
PMCF
identifying any need to immediately apply
any necessary corrective or preventive
actions;

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Post Market Surveillance (PMS)
Specific Requirements in the MDR

1. PMS system of the manufacturer (Article 83)

2. PMS plan (Article 84)

3. PMS report (Article 85)

4. Post Market clinical follow-up (PMCF) report (Article 61, 11 and Annex XIV, Part B)

 For Class III devices and implantables devices the PMCF evaluation report and if indicated the
Summary of Safety and Clinical Performance (SSCP, Article 32) shall be updated at least
annually

5. Periodic safety update report (PSUR, Article 86)

6. Summary of Safety and Clinical Performance (SSCP, Article 32)

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Chapter VII: PMS, vigilance and market surveillance
Article 83 – PMS system of the manufacturer

• For each device, manufacturers shall plan, establish, document, implement,

maintain and update a PMS system in a manner that is proportionate to the risk
class and appropriate for the type of device.
• The PMS plan shall be an integral part of the manufacturer’s QMS referred to in
Article 10(9).

• The PMS system shall be suited to actively and

systematically gathering, recording and analysing
relevant data on the quality, performance and safety
of a device throughout its entire lifetime, and to
drawing the necessary conclusions and to
determining, implementing and monitoring any
preventive and corrective actions.

35
PMS system of the manufacturer shall be used for (Article 83):
Device

Lifetime
QMS

PMS

36
 PMS – Article 83, 87
• If, in the course of the post-market surveillance, a
need for preventive or corrective action or both is
identified, the manufacturer shall implement the
appropriate measures and inform the competent
authorities concerned and, where applicable, the
notified body.

‘serious incident’ means any incident that directly or indirectly

led, might have led or might lead to any of the following:
a) the death of a patient, user or other person,
b) the temporary or permanent serious impairment of the
patient's, user's or other person's state of health,
c) a serious public health threat; • Where a serious incident is identified or a field
safety corrective action is implemented, it shall
‘field safety corrective action’ means corrective action be reported in accordance with Article 87.
taken by a manufacturer for technical or medical
reasons to prevent or reduce the risk of a serious
incident in relation to a device made available on the
market; 37
PMS – Article 84, 85, 86
Article 84 – PMS plan Article 85 – PMS Report Article 86 - PSUR

• The post-market surveillance system • Manufacturers of Class I devices Manufacturers of class IIa, IIb and III
referred to in Article 83 shall be devices shall prepare a PSUR for each
• Summary of results and conclusions
based on a post-market surveillance device and for each category/group of
from analysis of PMS data gathered
plan, the requirements for which are devices summarizing the PMS data per
as according to PMS plan
set out in Section 1.1 of Annex III. the PMS plan (Article 83).
• Include description and rationale for
• For devices other than custom-made Throughout the lifetime of the device,
any preventive and corrective action
devices, the post-market surveillance the PSUR shall include:
taken
plan shall be part of the technical • Conclusions of benefit-risk
documentation specified in Annex II. • Updated when necessary determination;

• Made available to NB and CA on • Main findings of PMCF

request • Sales volume, estimate of size and
characteristics of population and
frequency of usage
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Annex III – Technical Documentation on PMS

The technical documentation on post-market surveillance to be drawn up by the manufacturer in accordance with Articles
83 to 86 shall be presented in a clear, organised, readily searchable and unambiguous manner and shall include in
particular the elements described in this Annex.

1.1 a: The post-market surveillance plan shall address the collection and utilization of available information, in particular:

information concerning serious

records referring to non-serious
incidents, including information information from trend reporting
incidents and data on any
from PSURs, and field safety (Article 88)
undesirable side effects
corrective actions

relevant specialist or technical information, including feedbacks publicly available information

literature, databases and/or and complaints, provided by users, about similar medical devices
registers distributors and importers

39
Annex III
1.1 b: PMS plan
Shall cover at least:

• proactive and systematic process to collect the information referred to in previous slide (EN ISO 13485:2016, 8.2.1)

• Comparison between device and similar products on the market

• effective methods to assess the collected data (including complaints, market-related experience, trend reporting,
recognise significant data)

• suitable indicators and threshold values that shall be used in the continuous reassessment of the benefit-risk analysis
and risk management (Annex I, SPR 3)

• complaint investigation and analysis (EN ISO 13485:2016, 8.2.2)

• methods/protocols to manage events subject to the trend reporting regarding any statistically significate increase in the
frequency or severity of incidents (Article 88)

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40
Annex III

1.1 b: PMS plan

Shall cover at least:

• methods to communicate effectively with NB, CA, economic operators and users (EN ISO 13485:2016, 8.2.3)

• reference to procedures to fulfil the manufacturers obligations (PMS)

• procedures to identify and initiate appropriate corrective measures/corrective actions

• effective tools to trace and identify affected devices

• PMCF plan (Annex XIV, Part B) or justification as to why one is not applicable

1.2
The PSUR referred to in Article 86 and the post-market surveillance report referred to in Article 85.

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41
PMS in the MDR
MDR Requirements
QMS PSUR
Article 86
PMS
Article 83

Vigilance
Article 87-90

Reactive PMS

Proactive PMS

PMCF
Annex XIV SSCP
Article 32
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42
 Conclusion

• Classification rules – Annex VIII Added clarifications & new rules

• Conformity Assessment – Annex IX to Annex XI CECP - Class III implantable, certain Class IIb

• General Safety and Performance – Annex I Increased from 13 to 23

• Technical File Documentation – Annex II Prescriptive requirements

• PMS and PMS Technical Documentation – Annex III More specifics around PMS requirements

43
Where can I find full details of the changes?

bsigroup.com/MDR-revision
bsigroup.com/IVDR-revision

Webinars: bsigroup.com/webinars
Whitepapers: bsigroup.com/whitepapers

Please ask if you want any extra

information from BSI.

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