The MDCG has released a guidance document concerning Corrective and preventive action (CAPA) plan assessment. This guidance document is designed for conformity assessment bodies (CABs), notified bodies (NBs), designating authorities (DAs), and Joint Assessment Teams (JATs) involved in the implementation of Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).
The purpose of this document is to provide guidance for:
- Notified bodies (NBs) when developing a corrective and preventive action (CAPA) plan to address non-compliances (NCs) identified during joint assessments, in accordance with Article 39(5) of the MDR or Article 35(5) of the IVDR;
- Designating authorities (DAs) when reviewing and providing opinions on CAPA plans from notified bodies, as per Article 39(7) of the MDR or Article 35(7) of the IVDR; and
- Joint Assessment Teams (JATs) when evaluating the CAPA plan and the DA’s opinion, in line with Article 39(7) of the MDR or Article 35(7) of the IVDR.
While using the templates provided in Annex I (CAPA template) and Annex II (JAT review template) is not mandatory, following them can help streamline the structuring of CAPA plans and reviews, promoting a more efficient, consistent, and timely process for NBs, DAs, and JATs.
The guidance can be accessed using the following link
Annex I: TEMPLATE CAPA PLAN AND ASSESSMENT THEREON can be accessed using the following link
Annex II: Template JAT review of the CAPA and the DA’s opinion can be accessed using the following link
