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.

    关于作者

    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.

    Regulatory Affairs services

    Navigate Regulatory Complexity with Confidence

    Navigate complex regulatory landscapes with expert guidance across pharmaceuticals, medical devices, and IVD.

    Read more
    分享本文

    订阅生命科学领域的最新动态

    专家观点直达您的收件箱——选择您的兴趣。

    绝无垃圾邮件。随时取消订阅。

    继续阅读

    相关内容