The European Commission has released updated data from the survey conducted among Notified Bodies on certifications and applications under the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR). This update follows our posts on previous surveys, showing new data collected until June 30 from all Notified Bodies designated under MDR and IVDR.
NB survey results and conclusions
As of June 2023, the number of MDR applications amounted to roughly 13,000, whereas the number of MDR Certificates issued added up to 3,899. Moreover, under MDR, the average timeframe between the application to the Notified Body being lodged and the written agreement being signed is from 1 to 3 months on average.
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
In this sense, the number of application refusals has grown to 641 in June 2023.
The average timeframe to obtain a new MDR CE Certificate is between 6 to 12 months and more than 13 months (to a maximum of 24 months). For QMS assessments with the product, the average for the majority of Notified Bodies is more than 13 months.
Moreover, regarding Annex XVI products, the survey shows that 25 Notified Bodies already provide services for such products, while 13 NBs have indicated different reasons for their delay:
In total, 15,330 applications have been lodged with Notified Bodies, a necessary requisite for MDR legacy devices.
Concerning IVDD applications, 1,551 IVDD Certificates are still valid, while 500 IVDR Certificates have been issued. We can notice a constant rise in IVDR applications and IVDR certifications.
Likewise, Class D Certifications are mostly performed under Annex IX (II).
On the other hand, the main reason for the refusal of IVDR applications is, by far, the lack of completeness of the application.
The average timeframe to obtain a new IVDR CE Certificate is between 6 to 12 months for QMS assessment only and 13 to 18 months for QMS assessment with the product.