New MDCG 2024-12 on ‘Corrective and preventive action plan assessment’

New MDCG 2024-12 on ‘Corrective and preventive action plan assessment’

In October 2024, the Medical Device Coordination Group (MDCG) endorsed the new document MDCG 2024-12 on corrective and preventive action (CAPA) plan assessment, to provide guidance and templates for conformity assessment bodies, notified bodies (NBs), designating authorities (DAs) and joint assessment teams (JATs). Two forms have been added: MDCG 2024-12 Annex I Template CAPA plan and assessment and MDCG 2024-12 Annex II Template JAT review of the CAPA and the DA’s opinion.

For more, see the Commission’s web page on Guidance.