MDCG issues guidance and templates on CAPA plans
The European Commission’s Medical Device Coordination Group (MDCG) has issued guidance and templates that notified bodies (NBs) and designating authorities (DAs) can follow when implementing corrective and preventive action (CAPA) plans to address non-compliances that arise during a joint assessment of the NB.The guidance applies notified bodies under both the Medical Device Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR), and while voluntary, offers input on corrections, identifying root causes, and verifying the effectiveness of actions taken to remedy non-compliances. The document is meant to serve as a companion guidance to MDCG's MDCG 2022-13 Designation, re-assessment and notification of conformity assessment bodies and notified bodies.
The voluntary guidance is meant to be referenced by NBs when developing CAPA plans to address non-compliances identified during joint assessments, by designating authorities when reviewing and providing opinions on NBs’ CAPA plans, and by the joint assessment teams (JATs) when considering CAPA plans and designating authority opinions.
"Using [the templates] according to this guidance to structure CAPA plans and conduct their reviews will facilitate an efficient, consistent and timely CAPA review process for NBs, DAs and JATs," MDCG added.
MDCG said that the formal list of non-compliances provided by DAs from on-site assessments should determine what should be included in the CAPA plan.
“When completing the CAPA template, the wording, legal references, and classification of the NC(s) should be restated without modification,” the group added. “This includes the official DG SANTE translation of the NC, if applicable and provided.”
A key aspect of the guidance is good communication. It emphasizes that clear and traceable communication during the CAPA process will ensure the reviews are conducted efficiently and help JATs develop their CAPA opinion.
“The CAPA template is not designed to be used by DAs to document the NCs raised during assessments as DAs may have their own template for this purpose,” said MDCG. “However, if it suits their needs, DAs may use it for this purpose too.”
MDCG guidance and templates
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