The requirement to perform a pre-market Clinical Evaluation can be found in Part 1 of Annex X of the existing the Medical Device Directive (MDD). However, the requirements described in Annex X have long been considered inadequate, with the expectations of the European authorities published in the Guidance document MEDDEV 2.7/1 Clinical evaluation: Guide for manufacturers and notified bodies.
In the new European Union Medical Device Regulation (EU MDR), the requirement for a pre-market Clinical Evaluation can be found in the new Article 61 and in the new Annex XIV, Parts A and B.
Part A of the new Annex XIV is focussed on the pre-market phase and updates and extends Part 1 of the current MDD Annex X. While it is still less detailed than the current MEDDEV 2.7/1, it does require; (a) a Clinical Evaluation Plan (content is specified), (b) an evaluation of clinical data, and (c) a Clinical Evaluation Report (CER) manlig-halsa.se.
Part B of the new Annex XIV is focussed on the post market phase and is a significantly expanded requirement compared to the current MDD (Annex X 1.1C). While Post Market Clinical Follow-up (PMCF) has also been present in MEDDEV 2.7/1 since 2012, Part B of the new Annex XIV goes further than the current MEDDEV 2.7/1. Specifically, by; (a) detailing the requirements for the PMCF Plan and (b) introducing the requirement for a PMCF Evaluation Report.