MDCG 2020-7

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 (PMS) 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 plan, necessary to implement PMCF.

A PMCF plan shall specify the methods and procedures set up by the manufacturer, to proactively collect and evaluate clinical data from the use in or on humans of a CE marked medical device, placed on the market or put into service within its intended purpose, as referred to in the relevant conformity assessment procedure.

The aim of the PMCF plan is:

1. confirming the safety (1) and performance, including the clinical benefit if applicable, of the device throughout its expected lifetime;
    identifying previously unknown side-effects and monitor the identified side-effects and contraindications;
2. identifying and analysing emergent risks on the basis of factual evidence;
3. ensuring the continued acceptability of the benefit-risk ratio, referred to in Section 1 and 9 of Annex I in the MDR;
4. identifying possible systematic misuse or off-label use of the device, with a view to verifying that the intended purpose is correct.

The PMCF plan shall be part of the post-market surveillance plan.

The findings of the PMCF shall be analysed by the manufacturer who shall document the results in a PMCF evaluation report. The PMCF evaluation report shall be part of the clinical evaluation report and the technical documentation. The adequateness of the PMCF plan and its application is subject to assessment by the notified body. The notified body’s assessment of the clinical evaluation shall also cover the manufacturer’s procedures and documentation of the PMCF, as well as the justification in relation to non-performance of PMCF.

The purpose of the present template is to guide manufacturers in complying with the requirements of the MDR with respect to the compilation of the PMCF plan. 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 organised format.