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