The EU Commission published updated statistics related to MDR/IVDR certification, available: HERE

Forty-seven of the 51 Notified Bodies contributed responses, including 37 designated to the MDR/IVDR.

 

MDR Transition Overview

MDD/AIMDD Certificate Expiration Dates by Year

• 2022 – 1.4K
• 2023 – 4.3K
• 2024 – 17K
• Total – 23K

Current MDR Certification Status

• Applications filed – 8,120
• Certificates issued – 1,190

Time to Reach Certification (QMS+Product)

• 0% – 6-12 months
• 82% – 13-18 months
• 18% – 19-24 months

 

IVDR Transition Overview

IVDD Certificate Expiration Dates by Year

• 2022 – 38
• 2023 – 165
• 2024 – 482
• 2025 – 866
• Total – 1.5K

Of course, the majority of IVDs on the market are self-certified under the IVDD and eligible for the Article 110 transition provision.

For more information on transition deadlines, please read: What are Legacy Devices?

Current IVDR Certification Status

• Applications filed – 2.6K
• Certificates issued – 436

Time to Reach Certification (QMS+Product)

• 14% – 6-12 months
• 71% – 13-18 months
• 14% – 19-24 months

 

The takeaway

It is the same story of long review times and a potential supply gap period.

Considering the below data for MDR transition:

• • Roughly 23,000 MDD/AIMDD certificates expiring by May 2024
  • Roughly 4,100 MDR certificates issued
  • An average 13–18-month certification period

It seems almost certain there will be a supply gap.

If a manufacturer starts the MDR certification process by January 2023, realistically, they will achieve certification between February 2024 – July 2024. These companies can reasonably place some MDD CE Marked devices onto the market prior to 26 May 2024, to close the supply gap until their MDR certificate is issued.

However, if a company starts the MDR certification process in mid-2023, it will likely face a sales/supply gap in the European market.

What will the European Commission do about this, as May 2024 comes closer?

So far, the message from the Medical Device Coordination Group (MDCG) has been: MDR CE Mark, or face being off the market. Whether that will be the same stance a year from now is to be seen.

In the meantime, if you have not already started your MDR transition activities, we recommend doing so as soon as possible. Even if you reach out to a Notified Body today, you still likely face a waiting period before you are placed onto their schedule.

A full list of Notified Bodies designated to the MDR and IVDR is available: HERE