The European Commission has released an updated Notified Body Survey analysing the progress of certification applications under the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).
📌 Key takeaways from Q4 2024 data:
- over 25 000 MDR applications were submitted;
- Only 44% of MDR certificates have been issued;
- It takes less than 2 months from application lodging to a written agreement signed with the notified body;
- One of the main reasons for refusal of applications is because it is outside the scope of notified body’s designation;
- Incomplete submissions remain high;
- Time to reach a new MDR certificate remains around 12-18 months, for the majority of the notified bodies;
- This time is mostly taken by the manufacturer – time for revising the documents including application and technical documentation.
This reinforces the importance of early regulatory planning, well-prepared technical documentation, and expert support throughout the certification journey.
At MDRu, we work side-by-side with medical device manufacturers to:
✔️ Prepare robust submissions
✔️ Conduct gap analysis and technical reviews
✔️ Support communication with Notified Bodies
✔️ Anticipate and respond to clarification requests
📎 Download the full survey, here.
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