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Official Sign-Off For EU Medical Device Regulation Amending Text Due Today

 
• By Amanda Maxwell

The first legal stages in the process for implementing new rules that will extend the Medical Device Regulation transitional period and remove the one-year sell-off period conditions are nearly complete. But further work will be needed.

Retro image of lawyer signing important legal document on black desk. Over black background.
Sign Off Due 15 March

European Commissioner for Health and Food Safety, Stella Kyriakides, confirmed at the European Employment, Social Policy, Health and Consumer Affairs Council (EPSCO) meeting on 14 March that the Council of the EU and European Commission are due to officially sign the extension of the rules on medical devices on 15 March. News was awaited as Medtech Insight went to press.

The text is now likely to be published in the Official Journal of the European Union (OJEU) on 16 or 17 March, after which it will take effect.

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