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EMA Updates Q&A on MDR, IVDR

The European Medicines Agency (EMA) on Tuesday released an updated and revised questions and answers (Q&A) document on the implementation of the Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).

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

download here:

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

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