Revised MDCG 2021-4 Guidance Documents Released
Revised MDCG 2021-4 Guidance Documents Released
Regulatory Affairs In Vitro Diagnostics
Tuesday, 01 October 2024
Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
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On September 25, 2024, the Medical Device Coordination Group (MDCG) released Revision 1 of the guidance on the application of transitional provisions for the certification of Class D in vitro diagnostic medical devices under Regulation (EU) 2017/746 (MDCG 2021-4). This update provides additional clarifications regarding the operational start date of the European Reference Laboratories (EURLs) on October 1, 2024.
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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.
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