MDCG Guidance on CAPA Plan Assessment for Notified Bodies

The MDCG (Medical Device Coordination Group) has released a guidance document titled “Corrective and Preventive Action (CAPA) Plan Assessment: Guidance and Templates for Conformity Assessment Bodies, Notified Bodies, Designating Authorities, and Joint Assessment Teams”.

Who is the MDCG CAPA guidance for?

This guidance is specifically aimed at Conformity Assessment Bodies (CABs) and Notified Bodies involved in the implementation of Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR).

It outlines a structured process for documenting and addressing non-compliances identified during joint assessments, as stipulated under Article 39(5) of the MDR and Article 35(5) of the IVDR. Notably, the guidance includes a section dedicated to developing a CAPA plan.

While this guidance is not directly applicable to manufacturers, it serves as a critical resource for organizations involved in the conformity assessment process, reinforcing the importance of compliance and quality assurance in the medical device sector.

You can read the full guidance document here:

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