Current Stats
The number of total MDR applications has increased by ~3,500 since the October 2022 survey. Notified Bodies reported a total of 11,418 applications processed as of March 2023.
The number of MDR certificates has also increased marginally – from 1,190 to 2,951.
For IVD devices, there are only 950 IVDR applications lodged, and 331 certificates issued. This is not surprising, considering there are only 1,551 IVDD certificates currently issued, and a longer IVDR transition timeframe for all the other up-classed IVDs. That said, those IVDR deadlines will arrive before we know it.
Important Considerations
To be eligible for the extended MDR transition period, companies must have:
-
- Lodged an application with a Notified Body no later than 26 May 2024
- Signed an Agreement with the Notified Body no later than 26 September 2024
If you have not completed the above actions, then your device fails to remain a legacy device under the extension and you must cease marketing.
If companies wait until the absolute last minute, this only gives them 4 months between lodging the application and signing the agreement.
The best course of action is to not wait until the last minute to lodge an application. Why?
MDR Applications Rejected
It is possible your application could be rejected.
Of the reasons given for refusal, one of the largest is that the device was outside of the Notified Body’s designation. Next highest is that the application was not complete. Another reason is “insufficient notified body resources”.
Other reasons include that the manufacturer was not ready for MDR certification, e.g., “product did not meet essential requirements despite comprehensive feedback by the NB” and “PMS [Post-Market Surveillance] plan not at MDR level”.