EU MDR implementation – what is changing for the medical device industry?


This article focuses on the impact of the Medical Device Regulation (MDR) transition extension period and provides guidance for medical device manufacturers on the new Regulation (EU) 2023/607. MDR (EU) 2017/745 came into force in May 2017 and became applicable in May 2020. After multiple amendments to the MDR, the date of application (DoA) was extended to 26 May 2021 and transitional provisions set out in the MDR were extended to between 26 May 2026-31 December 2028. The transitional period is extended exclusively for legacy devices that meet the conditions for the application of the new transition period, and the length of the extension depends on the risk class of the specific medical device.

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