This document presents questions and answers on requirements relating to notified bodies under Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). The issues covered by this document have been identified in the context of joint assessments, and the document may be updated from time to time as new issues are identified.
I. ORGANISATIONAL AND GENERAL REQUIREMENTS
I.1. Are CABs obliged to follow guidance endorsed by the Medical Devices Coordination Group (MDCG)?
Guidance documents are by definition not compulsory. However, all guidance documents endorsed by the MDCG reflect the interpretation of the EU law jointly agreed by the authorities which are in charge of interpreting and applying the EU law. Hence notified bodies should be encouraged to apply these guidance documents (also taking into consideration Section 1.6.2 of Annex VII to the MDR/IVDR1).
Furthermore, it is to be noticed that the European Court of Justice often refers to guidance documents when developing its rulings. Hence Notified Bodies have an interest, also in terms of liability risk, to follow that guidance…