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).