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.
This document has been produced to provide guidance to Applicants, Marketing Authorisations Holders (MAH) and notified bodies (NB) as regards aspects falling within the scope of the Agency’s activities and should be read in conjunction with the new medical devices Regulation (EU) 2017/745, and the new in vitro diagnostic medical devices Regulation (EU) 2017/746. The medical devices regulation (MDR) and in vitro diagnostic medical devices regulation (IVDR) replace the three existing Directives (90/385/EEC,
93/42/EEC and 98/79/EC) for medical devices. The MDR has come into full application on 26 May 2021 but provides for a transitional period for certain devices until 26 May 2024. The IVDR will come into application on 26 May 2022 for in vitro diagnostic medical devices but also provides for a transitional period for certain devices until 26 May 2024. These regulations include provisions concerning the responsibilities of 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…
