This Question and Answer (Q&A) document provides practical considerations concerning the implementation of the medical devices and the in vitro diagnostic medical devices regulations in the context of combinations of medicinal products with medical devices.
This document has been produced to provide guidance to applicants, marketing authorisation holders (MAH) and notified bodies (NB) as regards aspects falling within the scope of the European Medicines Agency’s activities and should be read in conjunction with the medical devices Regulation (EU) 2017/745 (MDR), the in vitro diagnostic medical devices Regulation (EU) 2017/746 (IVDR) and the Medical Device Coordination Group (MDCG) guidance documents. The MDR and IVDR replace the three Directives
(90/385/EEC, 93/42/EEC and 98/79/EC) for medical devices. The MDR came into application on 26 May 2021 but provides for a transitional period for certain devices. The IVDR came into application on 26 May 2022 but also provides for a transitional period for certain devices. These regulations include provisions concerning the responsibilities of the EMA, National Competent Authorities (NCA) for medicinal products and medical devices and notified bodies as regards combinations of medicinal products with medical devices as follows…
