European Commission publishes results of 18th Notified Body survey under MDR and IVDR

The European Commission has published the results of the 18th Notified Body (NB) survey, conducted in November 2025 with data up to 31 October 2025, as part of the ongoing study on the availability of medical devices on the EU market.

The survey includes responses from all 52 notified bodies designated under MDR and/or IVDR, corresponding to a 100% response rate.

MDR: Applications, agreements and certificates

According to the survey (small dataset):

• 31,863 MDR applications lodged

• 21,426 written agreements signed

• 918 applications refused

In terms of certificates issued:

• 11,838 QMS certificates (7,069 first-time)

• 5,863 product certificates (3,493 first-time)

From the medium dataset:

• 33,175 total MDR applications (by Annex)

• 17,549 MDR certificates issued (by Annex)

Timelines for MDR certification

The survey reports the following timelines:

• For QMS certificates:

  • 59% of notified bodies: 13–18 months

  • 33%: 6–12 months

• For QMS + product certificates:

  • 53%: 13–18 months

  • 28%: 19–24 months

Application completeness and refusals

Regarding submission quality:

• 14 out of 51 MDR notified bodies report that more than 50% of submissions are complete before review

Main reasons for refusal include:

• Outside the scope of the notified body designation

• Application not complete

Time to written agreement

The survey indicates that:

• In 64% of cases, the time between application and written agreement is less than 2 months

IVDR: Applications and certificates

For in vitro diagnostic medical devices:

• 3,531 applications lodged

• 1,728 written agreements signed

• 111 applications refused

Certificates issued:

• 1,044 QMS certificates (655 first-time)

• 1,158 product certificates (913 first-time)

From the medium dataset:

• 3,634 IVDR applications

• 2,194 IVDR certificates issued

IVDR timelines

• QMS certificates:

  • 55% issued within 6–12 months

  • 36% within 13–18 months

• QMS + product certificates:

  • 75%: 13–18 months

  • 8%: 19–24 months

Conclusion

The 18th NB survey provides updated data on:

• Number of applications and certificates under MDR and IVDR

• Certification timelines

• Completeness of submissions

• Reasons for application refusal

All results are based on data reported by notified bodies up to 31 October 2025.

Read the full document below.