14th EU Survey Shows Growing MDR and IVDR Certification Activity but Persistent Delays

The European Commission has released the 14th Notified Body (NB) Survey on the implementation of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), assessing market availability and certification progress. A total of 51 Notified Bodies participated, providing data through February 2025.

Under the MDR, there were 28,489 applications, with 12,177 certificates issued and 650 rejected, mainly for incomplete or out-of-scope submissions. Most contracts were signed within two months, but certification typically took 13–18 months, especially for combined QMS and product evaluations. Few certificates were granted for Annex XVI products or reprocessed single-use devices.

Under the IVDR, 2,395 applications were submitted, yielding 1,490 certificates, with most approvals also requiring 6–18 months. Collaboration with EU reference laboratories was established for complex Class D devices.

Overall, application numbers continue to grow, but processing remains lengthy, highlighting the need for improved submission quality and regulatory efficiency.

19-10-2025