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Medical Device Regulation extended

Following informal contacts with the European Parliament, it is expected that the European Parliament will vote on the text of the Commission proposal without amendments as its position at first reading during the plenary session of 13-16 February 2023, through an urgency procedure and subject to legal-linguistic revision of the text.

Following informal contacts with the European Parliament, it is expected that the European Parliament will vote on the text of the Commission proposal without amendments as its position at first reading during the plenary session of 13-16 February 2023, through an urgency procedure and subject to legal-linguistic revision of the text.
February 7, 2023

On January 25, 2023, the Committee of Permanent Representatives agreed without amendments on the European Commission‘s proposal from January 6, 2023, aiming to extend the existing transitional period for medical devices covered by a notified body certificate or manufacturer’s declaration of conformity issued before 26 May, 2021, in a staggered and conditional manner until:

– December 31st, 2027 for higher risk devices
– December 31st, 2028 for medium and lower risk devices

It is expected that the European Parliament will vote on the text of the Commission proposal without amendments as its position at first reading during next week’s plenary session through an urgency procedure and subject to legal-linguistic revision of the text.

Stay tuned for updates!

For further information, you can contact us at: info@asphalion.com

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