MDCG 2020-8
Post-market clinical follow-up (PMCF) Evaluation Report Template
A guide for manufacturers and notified bodies
Disclaimer: This document is an interactive version of the original MDCG document. We will keep it up-to-date.
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.
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
We created a word template based on the MDCG 2020-8 document. Feel free to use it for your Technical Documentation. It is identical to the template in MDCG 2020-8 Rev. 0.
Revision History
April 2020 | Rev. 0