The EU Commission published an updated survey on Notified Body certifications and applications: HERE

The survey was conducted at the beginning of April 2023 and had 100% participation from the MDR/IVDR Notified Bodies (39 total).

Background

The purpose of the surveys is to monitor the current, and future, availability of medical devices on the EU market.  

For example, the October 2022 Notified Body Survey showed ~23,000 MDD/AIMDD certificates expiring by May 2024. Yet only ~8,000 MDR applications had been filed and only ~2,000 MDR certificates were issued. This was one of the motivating factors for the extension of the MDR transition period.

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”.

Average Timeframe: From Application to Written Agreement

One of the questions posed in the survey is: “What is the average timeframe between the application being lodged and the written agreement signed?”

The average timeframe is 2-3 months. However, 28% of the Notified Bodies reported timeframes between 3-6+ months. So, this is another factor to keep in mind.

Competition for a Notified Body

There are ~23,000 active MDD/AIMDD CE Certificates on the market right now, and only ~11,500 MDR applications lodged. That means within the next 10 months, another ~11,500 MDR applications may be lodged — this is ~1,150 applications per month.

Further, the above does not include any devices new to the market. Nor any Class I MDD legacy devices, which are now up-classed under the MDR. Those formerly self-certified legacy devices must also have a lodged application by 26 May 2024 to remain a valid legacy device. This includes products like reusable surgical instruments and many software and substance-based devices.

Notified Bodies are busy and are only going to get busier. If you have a legacy device, we strongly recommend contacting Notified Bodies as soon as possible. In the next (short) 10 months, you are competing with anywhere from 10K-15K other applications and only 38 Notified Bodies accredited to the MDR.