The European Commission has issued an updated document on their survey conducted among Notified Bodies on certifications and applications under the Medical Devices Regulation (MDR) and the In Vitro Devices Regulation (IVDR). The survey was conducted between April and May 2023, obtaining responses from all 39 Notified Bodies designated under MDR and IVDR.
NB survey results and conclusions
About 17 thousand MDD/AIMDD Certificates are expected to expire in 2023. As of March 2023, the number of MDR applications amounted to roughly 11.4 thousand, whereas the number of MDR Certificates issued added up to almost 3 thousand. Moreover, under MDR, the average timeframe between the application to the Notified Body being lodged and the written agreement being signed is 2 to 3 months.
On the other hand, the main reasons for the refusal of MDR applications are:
- The application is outside the scope of the notified body’s designation
- The application is not complete
- The product/device is wrongly classified
The average timeframe to obtain a new MDR CE Certificate is between 6 to 12 months only for QMS, reaching 13 to 18 months for QMS assessment with the product.
Concerning IVDD Certificates, 482 IVDD Certificates are expected to expire in 2024, while 866 are expected to expire in 2025. On the other hand, as of March 2023, 950 applications and 331 IVDR Certificates were issued.
The main reasons for the refusal of IVDR applications are:
- The application is not complete
- The product/device is wrongly classified
- The manufacturer withdrew the application
The average timeframe to obtain a new IVDR CE Certificate is between 13 to 18 months for QMS assessment with the product.
This and other documents are in the MDR & IVDR Notified Body section!
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