Regulatory Open Forum

Dear All

Another piece of great news, especially for those having trouble finding a notified body, not booked out. 

While everyone has been focusing on the MDR extension regulation proposal & its passing, the following delegated regulation is coming into effect tomorrow to relieve the strain on the notified bodies.

Commission Delegated Regulation (EU) 2023/502 of 1 December 2022 – taking effect on March 11^th 2023 - reduces the frequency of complete re-assessments of notified bodies from three years (1^st complete re-assessment) and four years (following the 1^st) to every 5 years in both cases; however, the competent authorities have the liberty to decide if complete re-assessment may be done sooner. See conditions in below link.

https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32023R0502&from=EN

In summary, MDR Article 44(10) has been rewritten to ease the workload of the notified bodies. 

Wish all a great weekend.

Best Regards,

Stephanie

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Stephanie Grassmann
Founder & Managing Director of MedTechXperts Ltd
Biberstein
Switzerland
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Thanks Stephanie for helping us not to miss this news!

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Tiina Tyni
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Original Message:
Sent: 10-Mar-2023 14:46
From: Stephanie Grassmann
Subject: EC Delegated Regulation (EU) 2023/502 reduces the frequency of complete re-assessments of notified bodies

Dear All

Another piece of great news, especially for those having trouble finding a notified body, not booked out. 

While everyone has been focusing on the MDR extension regulation proposal & its passing, the following delegated regulation is coming into effect tomorrow to relieve the strain on the notified bodies. <o:p></o:p>

Commission Delegated Regulation (EU) 2023/502 of 1 December 2022 – taking effect on March 11^th 2023 - reduces the frequency of complete re-assessments of notified bodies from three years (1^st complete re-assessment) and four years (following the 1^st) to every 5 years in both cases; however, the competent authorities have the liberty to decide if complete re-assessment may be done sooner. See conditions in below link.<o:p></o:p>

https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32023R0502&from=EN<o:p></o:p>

In summary, MDR Article 44(10) has been rewritten to ease the workload of the notified bodies. <o:p></o:p>

Wish all a great weekend.

Best Regards,

Stephanie

------------------------------
Stephanie Grassmann
Founder & Managing Director of MedTechXperts Ltd
Biberstein
Switzerland
------------------------------