The MDCG have released form templates relating to preliminary (re-)assessment of notified bodies. These templates are the following:
- MDCG 2024-6: Preliminary re-assessment review (PRAR) form template (MDR)
- MDCG 2024-7: Preliminary assessment review (PAR) form template (MDR)
- MDCG 2024-8: Preliminary assessment review (PAR) form template (IVDR)
- MDCG 2024-9: Preliminary re-assessment review (PRAR) form template (IVDR)
The forms are relevant to assessing if the notified bodies meet the requirements to continue operating. There are different forms, concerning the different legislations, MDR and IVDR, and also forms depending on whether it is the first assessment or a re-assessment.
The templates can be accessed using the following links:
