scope:

This document seeks to provide guidance for clinical data providing sufficient clinical evidence necessary to demonstrate conformity with the relevant GSPR, as per Article 61(1) MDR, for legacy devices CE marked with respect to Directives 93/42/EEC (MDD) or 90/385/EEC (AIMDD).

This document aims to provide guidance for manufacturers and notified bodies to prepare for the conformity assessment procedure according to the MDR.

This document does not provide comprehensive guidance with respect to the process or methodology relating to clinical evaluation. It is general and not restricted to any particular device technology or risk class. Following on from the principles described in Section 3 however, special attention is given to those described in Article 61(6).