MDCG 2024-12, rev. 1: MDCG Revises its Guidance on Corrective and Preventive Action Plan Assessment
9 October 2024
On 7 October, the Medical Device Coordination Group (MDCG) published the paper MDCG 2024-12 – Corrective and Preventive Action (CAPA) Plan Assessment, including annexes:
- Appendix I: TEMPLATE CAPA PLAN AND ASSESSMENT THEREON.
- Appendix II: TEMPLATE JAT REVIEW OF THE CAPA AND DA’s OPINION.
The guidance is aimed at conformity assessment bodies (CABs), notified bodies (NBs), designating authorities (DA) and joint assessment teams (JATs) involved in Regulation (EU) 2017/745 on Medical Devices (hereafter MDR) and Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices (hereafter IVDR).
It should also be read in conjunction with Guidance Document MDCG 2022-13, Rev. 1 Designation, Reassessment and Notification of Conformity Assessment Bodies and Notified Bodies.
MDCG 2024-12, rev. 1 provides guidance to:
- Notified bodies in drawing up the Corrective and Preventive Action Plan (CAPA) to address non-conformities arising from joint assessments (under Article 39(5) of the MDR or Article 35(5) of the IVDR),
- Designating authorities when conducting reviews and issuing opinions on CAPA plans of notified bodies (according to Article 39(7) of the MDR or Article 35(7) of the IVDR), and
- Joint assessment teams reviewing the CAPA plan and the DA’s opinion on it (according to Article 39(7) of the MDR or Article 35(7) of the IVDR).
The use of the templates in Annex I (hereafter “CAPA template”) and Annex II (hereafter “JAT review template”) of the guidance is not mandatory. However, applying the templates to structure and review CAPA plans in accordance with the guidance will enable an efficient, consistent and timely CAPA review process.
The formal list of nonconformities assessed on site and submitted by the DA serves as input to the CAPA process. The wording, legal references and categorization should be adopted unchanged when completing the CAPA template.
The CAPA process requires clear and transparent communication to ensure that the JAT efficiently reviews the CAPA plans approved by the DA, including the DA’s opinion on these plans, as this in turn facilitates the JAT’s final opinion.
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