2025-01

On May 15, 2024, there were 4 new MDCG Notified Body preliminary (re-) assessment review form templates published.

On January 10, 2025, the MDCG issued Revision 1 of MDCG 2024-7 and MDCG 2024-8 (PAR templates MDR and IVDR, including Annexes)

The documents can be downloaded in our library:

• MDCG 2024-6 Preliminary re-assessment review (PRAR) form template (MDR)
• MDCG 2024-7 Preliminary assessment review (PAR) form template (MDR) + Annex
• MDCG 2024-8 Preliminary re-assessment review (PAR) form template (IVDR) + Annex
• MDCG 2024-9 Preliminary re-assessment review (PRAR) form template (IVDR)

Source: European Commission