The Medical Devices Coordination Group (MDCG) has released this August a guidance on the designation, re-assessment and notification under MDR & IVDR of conformity assessment bodies (CABs) and notified bodies (NBs), with the aim of guiding competent authorities and joint assessment teams on these tasks. It is also meant as an aligning tool among working practices of designating authorities throughout the EU.
Starting with the designation activities, this document provides guidance on all stages, from the pre-assessment and off-site activities, referencing application forms MDCG 2021-15 & MDCG 2021-16, to the selection of the designating authority and transmission of the application to the European Commission, among other tasks. This is followed by the preliminary assessment (report), which is submitted to the European Commission and on-site assessment activities performed by the designating authority and the joint assessment team (JAT). As well as post on-site assessment activities, including JAT summary assessment report and assessment of the CAPA plan. Once all existing non-compliances have been solved the designating authority will carry out the designation taking into consideration the MDCG’s recommendation (max. 42 days after receiving the JAT Final Opinion) and the new CAB will appear in the NANDO database in case Member States do not oppose to its notification within 28 days.
The second part of this guidance addresses the re-assessment of notified bodies outlining the necessary documentation to be provided, as well as all the activities (pre-assessment, on-site assessment and post on-site assessment) that lead to the re-assessment decision.
Final pages contain several clarification flowcharts on process and timeline of the designation assessment and re-assessment procedures.
Are you interested in knowing more about MDCG guidances? Please see our MDCG MDR & MDCG IVDR sections.
Please note that a similar document was issued as NBOG’s Best Practice Guide in 2017.
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