In February 2024, the European Commission published the results of the sixth survey conducted until October 2023 on MDR and IVDR certifications and applications. As of October 2023, there were 41 notified bodies designated under the Regulations. As in previous surveys, this document includes answers from all notified bodies. Such surveys are essential to understand the transition status of devices to foresee and prevent market disruptions of medical devices.
Status of MDR and IVDR applications and certifications
Compared with data obtained in June 2023 and explained in our previous post, the number of MDR and IVDR applications increased significantly. Between February 2021 and October 2023, MDR notified bodies received almost 18 thousand applications and issued about 5.6 thousand product certificates and over 10 thousand QMS certificates. Over the same time, the number of applications that IVDR notified bodies received went from 249 to 1.5 thousand, while the amount of certificates issued passed from seven to 702. Data from October 2023 show that the number of notified bodies’ clients is slightly higher among the non-EU group, with 53% of MDR manufacturers and 57% of IVDR manufacturers based outside the EU.
In most cases, it takes less than two months to have a written MDR agreement with the notified body after the application submission. This information is essential for manufacturers transitioning from the MDD to the MDR and requiring an application submission by May 2024 and a written agreement with a notified body by September 2024.
Among the most common reasons for refusal of an application, notified bodies indicated “outside the scope of notified body’s designation”, “application not complete”, and “wrong qualification of product/classification of device”. However, incomplete documentation rate remains high also among accepted applications.
In particular, MDR notified bodies indicated the following reasons:
Most importantly, manufacturers of medical devices need to take into account the time necessary to reach a new certification. In about half of the cases, a QMS and product certification require 13 to 18 months under the MDR. Under the IVDR, the same time range applies to 67 percent of QMS and product certification.
In light of the proposal to extend the IVDR transitional period and the current extended legacy period for MDR manufacturers, being prepared for the transition and approaching a notified body in time is essential for legacy devices. Contact MDlaw Team for more information!
Leave a Reply