QbD Group
    Regulatory Update

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

    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). 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.

    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.

    About the Author

    Kirsten Van Garsse
    Kirsten Van Garsse

    MSc Biomedical Sciences · Business Unit Manager RA IVD & Representative Services

    With over 20 years of experience in the diagnostics industry, Kirsten leads the IVD Regulatory Affairs business unit at QbD Group, guiding regulatory strategy and compliance across all IVDs with a focus on companion diagnostics.

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