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

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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.

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