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:
• For medical devices that form an integral product with a medicinal product (Regulation (EU) 2017/745, second subparagraph of Article 1(8) and 1(9)), new requirements to provide an EU declaration of conformity issued by the medical device manufacturer, or a certificate of conformity (so-called hereafter EU certificate) or an opinion from a notified body designated under Regulation (EU) 2017/7452 for the type of device in question are applicable in certain circumstances (Art. 117).
• For medical devices incorporating a medicinal substance with action ancillary to the device, Regulation (EU) 2017/745 Article 1 (8), the notified body must seek a scientific opinion from either an NCA or EMA
. The notified body must seek the opinion of EMA for medicinal products falling exclusively within the scope of centralised procedure , or that incorporate human blood or plasma derivatives.
• For medical devices that are composed of substances, or of combinations of substances, that are systemically absorbed by the body in order to achieve their intended purpose, the notified body must
seek a scientific opinion from either an NCA or EMA (Regulation (EU) 2017/745 Article 52(11))
• For companion diagnostics, the notified body must seek a scientific opinion from either an NCA or EMA (Regulation (EU) 2017/746, Article 48(3) and (4)6).