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.
About the Author
MSc Biomedical Sciences · Director Authorised Representative Services & Manager IVD – Regulatory Affairs
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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