Europe – 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 – October 2024

This guidance document is intended for conformity assessment bodies (CABs), notified
bodies (NBs), designating authorities (DAs), 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 be read in
conjunction with the guidance document MDCG 2022-13 “Designation, re-assessment and
notification of conformity assessment bodies and notified bodies”…