MDCG 2024-12 released
MDCG 2024-12 released
Regulatory Affairs Medical Devices In Vitro Diagnostics
Monday, 14 October 2024
Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
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On October 7th, 2024, the Medical Device Coordination Group (MDCG) released a new guidance and templates for the assessment of Corrective and Preventive Action (CAPA) plans, intended for conformity assessment bodies, notified bodies, designating authorities, and Joint Assessment Teams involved in the implementation of Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR).
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It includes detailed sections on corrections, root cause analysis, corrective and preventive actions, and actions for verification of effectiveness. The document also provides templates in Annex I and Annex II to facilitate a consistent and efficient CAPA review process.
What does it mean to you?
MDCG 2024-12 does not directly target manufacturers of IVDs and medical devices. Nonetheless, corrective actions to be taken by notified bodies may have an impact on existing certificates for such manufacturers.
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