Theme Clinical Evaluation – clinical evidence
Target audience Manufacturer, Notified bodies
Product concerned MD CE-marked  under Directives
Regulatory reference MDR (EU) 2017/745

Article 61

Annex XIV – Part A

Documents mentioned MEDDEV 2.7/1  rev. 4 (2016) : Clinical evaluation: Guide for manufacturers and notified bodies

MEDDEV 2.12/2 rev 2 (2012) : Post market clinical follow-up studies

IMDRF/GRPP WG/N47 (2018) : Essential principles of safety and performance of medical device and IVD medical devices

IMDRF MDCE WG/N56 (2019) : Clinical Evaluation


ENThis guide provides specific guidance on aspects of clinical evaluation for devices that already have a history of certification under the Directive (legacy devices) and are preparing for a conformity assessment procedure in accordance with the Regulations.

Note : the term « legacy devices » identifies Medical Devices that are covered by a valid certificate issued in accordance with a Directive and that continues to be placed on the market after the date of application of the Regulation

It develops the concept of sufficient clinical evidence necessary to demonstrate compliance with the EGSP. It includes 3 relevant annexes:

– An appendix that highlights the steps described in MEDDEV 2.7/1 rev. 4 found in the MD Regulation.

– The minimum content of the clinical evaluation plan specific to legacy devices

– A Suggested hierarchy of clinical evidence