EU MDR Extended Transitions: Practical Advice From Commission

Nine-page document gives medtechs answers to 18 key questions

 
• By Ashley Yeo

Concerns and uncertainties arising among manufacturers following the recent extension of the MDR's transition periods have been addressed in a question-and-answer document issued by the European Commission.

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The European Commission has released an explanatory document for companies wishing to utilize the extended transition periods for Medical Device Regulation “legacy products.” The question-and-answer format document, issued on 24 March, has not been formally endorsed by the commission.

The transition extensions were set out in the recently passed amending regulation 2023/607, which came into force on 20...

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