MDCG 2024-12 released

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.

MDCG 2024-12: Corrective and preventive action (CAPA) plan assessment: guidance and templates for conformity assessment bodies, notified bodies, designating authorities and joint assessment teams

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.