Questions & Answers on Implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations ((EU) 2017/745 and (EU) 2017/746)

On 21 October 2019, EMA updated the questions and answers. This update focuses on aspects relating to the implementation and applicability of the requirements of Regulation (EU) 2017/745 to medicinal products with an integral or co-packaged medical device.

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 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 diagnostics regulation (IVDR) replace the three existing Directives (93/42/EEC, 98/79/EC and 90/385/EEC) for medical devices. The Regulations entered into force on 25 May 2017; however, they will have a transition period to allow manufacturers, notified bodies and authorities to comply with the changes and will come into full application on 26 May 2020 for medical devices and 26 May 2022 for in vitro diagnostics.

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