New MDCG 2024-6, 7, 8 and 9 as preliminary (re-)assessment review form templates for MDR and IVDR

In May 2024, the Medical Device Coordination Group (MDCG) endorsed the documents MDCG 2024-6 Preliminary assessment review (PAR) form template (MDR), MDCG 2024-7 Preliminary assessment review (PAR) form template (IVDR), MDCG 2024-8 Preliminary re-assessment review (PRAR) form template (MDR) and MDCG 2024-9 Preliminary re-assessment review (PRAR) form template (IVDR). They have been developed by the MDCG Subgroup on Notified Body Oversight (NBO).

For more, see the Commission’s webpage on guidance.