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Updated Guidance on MDR Surveillance: MDCG 2022-4, Revision 2

Regulatory Affairs Medical Devices
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Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
On May 27th, 2024, the Medical Device Coordination Group (MDCG) released a second revision on the guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates according to the MDD or the AIMDD (MDCG 2022-4 Revision 2).
Updated Guidance on MDR Surveillance: MDCG 2022-4, Revision 2
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Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates according to the MDD or the AIMDD

This second revision includes adjustments all over the document to align it to Regulation (EU) 2023/607 of the European Parliament and of the Council of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices.

 

CTA RA update MD

 

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