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 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.