At the beginning of October, the Medical Device Coordination Group (MDCG) presented the new document MDCG 2024-12. It provides comprehensive guidelines for the assessment of corrective and preventive action plans (CAPA) for conformity assessment bodies, notified bodies, designating authorities and joint assessment teams (JAT). The guidelines are intended to standardize the process for dealing with NCs (nonconformities) and make it more efficient. The document is supplemented by two annexes: a sample CAPA plan and a template for the CAPA assessment by JAT and DA.
