The guidance outlines how the IVDR transitional provisions relate to expert panels and EURLs. Effective October 1, 2024, EURLs will be fully operational and will undertake specific responsibilities as detailed in Articles 10-16 of Commission Implementing Regulation (EU) 2022/944. Devices certified under the IVDR prior to the activation of the EURLs will maintain valid certification until their specified expiry dates. However, sample or batch testing will be required for all certified devices falling under the EURLs’ scope. In these instances, Notified Bodies are obligated to coordinate with the EURLs to meet the requirements set forth in Articles 10, 11, and 13 of the Commission Implementing Regulation.
What does it mean to you?
MDCG 2021-4 Revision 1 is relevant to all manufacturers of Class D IVDs, as it may clarify questions regarding the operational procedures of the EURLs.
关于作者
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.
Navigate Regulatory Complexity with Confidence
Navigate complex regulatory landscapes with expert guidance across pharmaceuticals, medical devices, and IVD.
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