Survey Results from Team Notified Body on the MDR and IVDR

The Team Notified Body has just published the results of a survey on the status of implementation of the Medical Device Regulation (MDR, Regulation (EU) 2017/745) and the In-vitro Diagnostic Regulation (IVDR, Regulation (EU) 2017/746) up to the end of 2025.

Who is TEAM Notified Body?

TEAM Notified Body (TEAM-NB) has been existing since 2001 and currently has 44 members from 20 countries. The group's aim is to promote harmonisation among Notified Bodies.

What does the survey show?

In total, the Notified Bodies that are members of TEAM-NB had issued 17,260 certificates by the end of 2025. There is still a gap between applications under the MDR (25,978) and the certificates issued (13,953). The situation is similar for the In Vitro Diagnostic Medical Devices Regulation (IVDR, Regulation (EU) 2017/746). There are 3,021 applications compared to 2,500 certificates. 85% of the certificates issued relate to the MDR, 15% to the IVDR. The survey results then go into detail regarding the distribution of various conformity assessment procedures for both the MDR and the IVDR. Applications have increased significantly since 2020 (MDR: 1,661, IVDR: 230) (MDR: 25,978, IVDR: 3,102).

And how long does it take for a certificate to be issued? The average time taken to issue a certificate under the MDR is 13-18 months for the vast majority (48%). This timeframe is also the most common for IVDR certificates (61%).
Also of interest is the number of certificates issued in accordance with ISO 13485 (21,142) and the Medical Device Single Audit Programme (MDSAP) (3,059).

Conversely, however, 1,090 certificates were also withdrawn in 2025. The reasons were:

• Cessation of activities due to the expiry of the Medical Devices Directives
• Contractual obligations not met
• Financial problems
• Deficiencies not rectified
• Negative assessment
• Refusal of an audit or unavailability
• Change of Notified Body
• Unannounced audit was unsuccessful

The distribution of companies by size is also of interest. For medical devices, the figures are:

• 9% large companies
• 25% medium-sized companies
• 45% small companies
• 21% "micro-companies

For in vitro diagnostic manufacturers, the figures are as follows:

• 10% large companies
• 31% medium-sized companies
• 50% small companies
• 8% 'micro-firms'

The ratio of small and 'micro-firms' outside the EU (49.5%) and within the EU (50.5%) is almost the same.

You can view the full survey results on the Team-NB website.