Medical Device       
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MDCG 2020-8 
  
 Post-market clinical follow-up (PMCF) Evaluation Report Template 
A guide for manufacturers and notified bodies                
 
 April 2020 
 
  
 
This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 
2017/745. The MDCG is composed of representatives of all Member States and it is chaired by a representative of the European 
Commission.The document is not a European Commission document and it cannot be regarded as reflecting the official position of the 
European Commission. Any views expressed in this document are not legally binding and only the Court of Justice of the European 
Union can give binding interpretations of Union law. Medical Device       
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Post-market clinical follow-up (PMCF) Evaluation Report Template  
A guide for manufacturers and notified bodies 
 
  Medical Device       
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Contents 
Introduction  ........................................................................................................................................................................................................................................... 4 
Post-market clinical follow-up evaluation report Template  ............................................................................................................................................................ 4 
Section A. Manufacturer contact details ....................................................................................................................................................................................... 5 
Section B. Medical Device description and specification  .......................................................................................................................................................... 5 
Section C.   Activities undertaken related to PMCF: results  ..................................................................................................................................................... 7 
Section D.  Evaluation of clinical data relating to equivalent or similar devices  .................................................................................................................... 7 
Section E. Impact of the results on the technical documentation  ............................................................................................................................................ 7 
Section F.  Reference to any common specification(s), harmonized standard(s) or guidance document(s) applied  ...................................................... 9 
Section G. Conclusions  .................................................................................................................................................................................................................. 9 
 
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 Introduction 
 
The Medical Device Regulation (EU) 2017/745 (MDR) considers the post-market clinical follow-up (PMCF) as a continuous process that 
updates the clinical evaluation and that shall be addressed in the manufacturer’s post-market surveillance plan. The MDR reinforces the 
PMCF process by the manufacturer, devoting part B of Annex XIV to it and providing a set of requirements for developing a PMCF plan 
and its evaluation report, necessary to its implementation.  
 
The manufacturer shall analyse the findings coming from the activities foreseen in the PMCF plan and document the results in this PMCF 
evaluation report that shall be part of the clinical evaluation report and the technical documentation. 
  
The conclusions of the PMCF evaluation report shall be taken into account to update eventually the clinical evaluation, the risk 
management documentation, the post market surveillance plan and the SSCP, if applicable. 
 
The purpose of the present templates is to guide manufacturers in complying with the requirements of the MDR with respect to the 
compilation of  the PMCF evaluation report. This would assist manufacturers in a harmonised and complete presentation of post market 
clinical data and facilitate the activity of notified bodies and competent authorities in finding the information in an organized format. 
 
Post-market clinical follow-up evaluation report Template  
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  
Rev Revision date Description of change Revised by 
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 Section A. Manufacturer  contact details 
Legal manufacturer name: 
Address: 
SRN: 
Person responsible for regulatory compliance: 
E-mail: 
Phone: 
Fax: 
Authorised representative (if applicable): 
Address: 
Contact person:  
E-mail: 
Phone: 
Fax: 
 
Section B. Medical Device description and specification 
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: Medical Device       
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 Intended purpose1 
Intended users 
Basic UDI-DI: 
Intended patient population: 
Medical condition(s)2: 
Indications: 
Contraindications: 
Warnings:  
List and description of any variants and/or configurations covered by this plan: 
List of any accessories covered by this plan: 
Certificate number (if available): 
CND code(s)3:  
Class: 
Classification rule: 
Expected lifetime4  
Novel product                                ☐  yes    ☐  no 
Novel related clinical procedure:   ☐  yes    ☐  no 
Explanation of any novel features: 
 
 
                                                             
1 Intended purpose means the use for which a device is intended according to the data supplied by the manufacturer on the label in the instructions for use or in promotional or sales 
materials or statements and as specified by the manufacturer in the clinical evaluation (MDR, Article 2(12)).  
2 It refers to the clinical condition that is to be diagnosed, prevented, monitored, treated, alleviated, compensated for, replaced, modified or controlled by the medical device. 
 
4 The expected lifetime is to be defined during the design input phase by considering the current state of the art for a specific intended use and indication of a device.  Medical Device       
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 Section C.   Activities undertaken related to PMCF: results  
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.5 
 
Section 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 / similar 
device Results discussed References used to get the 
results (publications, part of 
technical documentation from 
this equivalent / similar device) 
 
 
 
 Section E. Impact of the results on the technical documentation  
 
                                                             
5 For the analysis and assessment of the clinical data collected, some parts of section 9.3.1 from Meddev 2.7/1 rev.4 could be used to assess the quality of data. 
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 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 analyzed 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 analyzed and monitored: 
 
- 
- 
- 
 
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 Analysis outcome to be reported in the risk management file updated: 
- 
- 
 
 
 
 
 
Section F.  Reference to any common specification(s), harmonized standard(s) or guidance document(s) applied  
 
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 guidances listed in the PMCF plan. 
 
Common Specification(s) applied 
(Title, date and version) 
 
Harmonised standard(s) applied 
(Title, date and version) 
 
Guidance(s) followed 
(Title, date and version ) 
 
 
Section 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. Medical Device       
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