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FO-061 PMCF Report Template

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MERIEM RIANI
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405 views5 pages

FO-061 PMCF Report Template

Uploaded by

MERIEM RIANI
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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FORM Code : FO.

060
POST MARKET CLINICAL FOLLOW UP Version : 01
- REPORT- Issue date :

Post-market clinical follow- up (PMCF) plan corresponding to the present evaluation report

PMCF plan number and version:

Post-market clinical follow- up (PMCF) Evaluation Report

PMCF report number:

PMCF report date:

PMCF report version:

Revision History:

Revision Revision Revised by


Description of change:
: date:

Related to SOP.014 /Change control xxxx Creation Page 1 de 5


FORM Code : FO.060
POST MARKET CLINICAL FOLLOW UP Version : 01
-REPORT- Issue date :

Table of Contents
A. Manufacturer contact details..................................................................................................3
B. Medical Device description and specification......................................................................3
C. Activities related to PMCF: General and specific methods and procedures.....................4
D. Reference to the relevant parts of the technical documentation........................................5
E. Evaluation of clinical data relating to equivalent or similar devices..................................6
F. Reference to any applicable common specification(s), harmonized standards(s) or
applicable guidance document(s)..........................................................................................6
G. Estimated date of the PMCF evaluation report.....................................................................6

Related to SOP.014 /New document Page 2 de 5


FORM Code : FO.060
POST MARKET CLINICAL FOLLOW UP Version : 01
-REPORT- Issue date :

A. Manufacturer contact details

Manufacturer:
Legal manufacturer name:
Address:
SRN:
Person responsible for regulatory compliance:
E-mail:
Phone:
Fax:
Authorised representative (if applicable):
Authorised representative name:
Address:
Contact person:
E-mail:
Phone:
Fax:

B. Medical Device description and specification

Description and specification: (MDR Annex ll §1.1)


Refer to section B from PMCF plan, if there are no changes.
If there are changes from PMCF plan, please fill in the different requested fields highlighting those
changes.
Product or trade name:
Model and type:
General description of the device:
Intended purpose:
Intended users:
Basic UDI-DI:
Intended patient population:
Medical condition(s):
Indications:
Warnings:
List and description of any variants and/or configurations covered by this plan:
List of any accessories covered by this plan:
CND code(s):
Class:
Classification rule:
Expected lifetime:
Novel product: ☐Yes ☐No
Novel related clinical procedure: ☐Yes ☐No
Explanation of any novel features:

Related to SOP.014 /New document Page 3 de 5


FORM Code : FO.060
POST MARKET CLINICAL FOLLOW UP Version : 01
- REPORT- Issue date :

C. Activities undertaken related to PMCF: results

(you can delete this table; For your information only)


In this section the manufacturer shall report all the activities described in section C of the PMCF plan which
have been performed, all the collected clinical data obtained from those completed activities, as well as any
justification of deviations from the plan.
The discussion shall include the analysis of the findings, whether positive or negative and also the potential
impact on the different documents (clinical evaluation report, risk management file, SSCP, etc…) initially
reviewed during the conformity assessment.
It is expected for each activity performed, a description in different subsections, related to the type of
activities (device registry, PMCF studies, real world evidence, surveys about the use of device, etc…), and
for each subsection, a description about the quality of data collected

D. D. Evaluation of clinical data relating to equivalent or similar devices

In this section the manufacturer shall report all the clinical data collected relating to an equivalent device or
selected similar device(s), provide an analysis and conclusions, and whether changes of the state of the art,
or newly identified hazards would have an impact on the devices benefit-risk determination, the clinical
evaluation and/or the PMCF plan.

Product name of equivalent/ Results discussed References used to get the


similar device results (publications, part of
technical documentation from
this equivalent/similar device)

E. Impact of the results on the technical documentation

Reference to the relevant parts of the technical documentation:


In this section, the manufacturer shall discuss the aggregate results coming from each PMCF activity
planned and performed, described in section C, but also results coming from equivalent and/or similar
device, described in section D, which are considered to impact the technical documentation and at least the
following documents shall be considered:
1. Clinical evaluation report - CER (date and version)
☐ No relevant information from the clinical evaluation report have been considered.
If applicable, it is expected from manufacturer to describe why some information that might have an impact
on the CER have not been considered.
Relevant information analysed and monitored:
-
-
Analysis of the outcome is to be reported in the updated clinical evaluation report.
2. Risk management file (date and version)
☐ No relevant information from the risk management file have been considered
If applicable, it is expected from manufacturer to describe why some information that might have an impact
on the risk management file have not been considered.
Relevant information analysed and monitored:
-
-
Analysis outcome to be reported in the risk management file updates:
-

Related to SOP.014 /Change control xxxx Creation Page 4 de 5


FORM Code : FO.060
POST MARKET CLINICAL FOLLOW UP Version : 01
- REPORT- Issue date :

F. F. Reference to any applicable common specification(s), harmonized standards(s) or


applicable guidance document(s)Reference to the relevant parts of the technical
documentation:

In this section the manufacturer should point out whether the collected clinical data related the device in
question still confirm adherence to applied common specifications and/or applied harmonized standards,
and/or guidance’s listed in the PMCF plan.

Common specification(s) applied:


(Title, date and version)

Harmonised standards applied


(Title, date and version)

Guidance (s) followed


(Title, date and version)

G. G. Conclusions:

In this section, it is expected that the manufacturer shall provide an overall conclusion of the findings and
relate them to the aims of the PMCF plan. The conclusions shall be taken into account in the following
clinical evaluation and in the risk management. Finally, this conclusion shall highlight if any need for
preventive and/or corrective measures has been identified. The conclusion may also give input to the next
PMCF plan.

Related to SOP.014 /Change control xxxx Creation Page 5 de 5

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