MDCG Presentations from April “Extraordinary” Meeting & Team Notified Body Internal Survey
15 May 2024
UK MHRA Updates: Draft Policy for International Recognition Framework & New IVD Consultation
21 May 2024Today the EU Commission published an update on the status of MDR/IVDR progress. It is the 8th survey since the project started and contains results as of 29 February 2024.
The presentation is available: HERE
Overview
Please review the presentation for all the details and caveats. Below we highlight a few items of interest:
MDR:
- There have been 20,424 applications lodged, and 6,978 certificates issued
- Average timeframe between lodging an application and signing an agreement is 1-2 months
- There have been 454 application refusals, with the highest reason being the device is outside the scope of the Notified Body’s designation, and the next highest being that the application is not complete
- Year over year shows a 73% increase in applications lodged and 55% increase in written agreements signed
- Timing per Notified Body to reach new certification (QMS + Product):
- 40%: 13-18 months
- 21%: 19-24 months
- 19 %: 6-12 months
- 16%: 24+ months
- 5%: less than 6 months
IVDR:
- There have been only 1,634 applications lodged, and 798 certificates issued
- 370 of the applications were for Class D devices
- Year over year shows a 68% increase in applications lodged and 62% increase in written agreements signed
- Timing per Notified Body to reach new certification (QMS + Product):
- 75%: 13-18 months
- 17%: 19-24 months
- 8%: less than 6 months
Note that the Application incompleteness rate remains high for both MDR and IVDR.
The above is a combination of devices transitioning from 1) MDD/AIMDD/IVDD CE Certificates to MDR/IVDR CE Certificates, 2) MDD/AIMDD/IVDD self-certified devices which have been up-classed under the MDR/IVDR and now require Notified Body CE Marking, and 3) devices new to the EU market.
