On August 1st, 2025, the European Commission released an updated Notified Bodies survey, providing detailed data on applications, refusal reasons, and average certification timelines under MDR and IVDR.
📊 MDR highlights:
• Gradual increase in issued certificates, but still far below application volumes
• Main reasons for refusals: “Applications not complete” (39%) and “Outside the scope of NB designation” (26%)
• Average time from contract signature:
- MDR QMS: 51% of NBs take 13–18 months; 36% take 6–12 months
- MDR QMS + Product: Longer — 60% take 13–18 months; 29% take 19–24 months
• On average, 58% of the process time is with the manufacturer, and 42% with the NB
📊 IVDR highlights:
• Gradual increase in certificates issued, but still far below the number of applications
• Reasons for refusals vary widely
• Average time from contract signature:
- IVDR QMS: 55% of NBs take 6–12 months; 27% take 13–18 months
- IVDR QMS + Product: Longer — 64% take 13–18 months; 9% take 19–24 months
• On average, 61% of the process time is with the manufacturer, and 39% with the NB
👉 At Instituto Pedro Nunes (IPN), we help medical device and IVD companies achieve certification with optimised documentation, effective strategies, and strong engagement with Notified Bodies.
🔗 Access the full survey results (PDF).