New MDCG Guidance Documents Released: Key Updates and Insights

On May 15th, 2024, the Medical Device Coordination Group (MDCG) released 4 new documents for notified bodies.

On May 15th, 2024, the Medical Device Coordination Group (MDCG) released 4 new documents for notified bodies:

• MDCG 2024-6 preliminary re-assessment review (PRAR) template under Regulation (EU) MDR 2017/745
• MDCG 2024-7 preliminary assessment review (PAR) template under Regulation (EU) MDR 2017/745
• MDCG 2024-8 preliminary re-assessment review (PAR) template under  Regulation (EU) IVDR 2017/746
• MDCG 2024-9 preliminary re-assessment review (PRAR) template under Regulation (EU) IVDR 2017/746
  
  

These form will be used to document the Designating Authorities (DA) review of the Notified Bodies documentation for (re-)assessment.

What does this mean to you?

MDCG 2024-6/7/8 and 9 are of relevance for the designation of Notified Bodies under MDR and IVDR.