Med-Tech Innovation February 2, 2023

Eamonn McGowran, medical devices regulatory specialist and associate director at global drug development consultancy, Boyds, explains the European Commission’s proposal to extend the Medical Device Regulation (MDR) transition period and outlines the key regulatory changes for developers of both devices and medicines to be aware of.

At the Employment, Social Policy, Health, and Consumer Affairs (EPSCO) meeting on 09 December 2022, the European Commissioner for Health and Safety, Stella Kyriakides, put forward proposals in her opening speech to extend the transition rules of the Medical Devices Regulation (EU) 2017/745.

The Medical Devices Regulation (MDR) was adopted by the European Parliament and the Council in 2017. The Regulation states that medical devices can be placed on the EU market under...

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