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MedTech Europe welcomes the recent publication of the European Commission’s Q&A on practical aspects of the implementation of Regulation (EU) 2023/607 and calls for continued work to address remaining challenges

Posted on 06.04.2023

After the political approval of both the European Parliament and the Council of the European Union, the European Commission’s proposal for an amendment of the Medical Devices Regulation and IVD Regulation has officially become law on 20 March 2023, with its publication in the Official Journal of the European Union.

Following this major milestone, the European Commission has published a Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices.

Looking ahead, it is now necessary to focus on solving the remaining MDR and IVDR implementation and governance challenges, as well as on creating clear regulatory pathways for strengthening the role of the European Union as an attractive region for research, innovation, and development.

For further information, please contact Merlin Rietschel, Senior Manager Medical Devices.