The European Association of Notified Bodies for Medical Devices, Team-NB, has released the results of its annual survey covering the 2025 activity of its 41 designated members.
After several years of strong expansion, the sector is losing momentum. Both the number of certificates issued and applications received under the MDR and IVDR regulations slowed in 2025, across medical devices and in vitro diagnostics alike.
On the workforce front, the picture is concerning. For the first time in over a decade, staffing levels within notified bodies have declined. the number of internal conformity assessment employees fell by 8%, while the use of subcontractors dropped by 21%. The suspension of manufacturer applications and the postponement of ongoing procedures are directly responsible for this reversed pressure. Team-NB warns that some bodies may be forced to shut down if the trend continues.
File quality also remains a persistent issue. For MDR, 65% of submitted dossiers are still missing at least half of the required information. The IVDR situation is more critical, with 42% of files lacking three-quarters of the necessary documentation. In response, Team-NB has stepped up its manufacturer training programme, with over 1,400 cumulative participants to date across MDR and IVDR tracks.
Also worth noting: submissions for artificial intelligence-based devices dropped by half in 2025, even as the number of AI certificates issued grew by 40%.
Team-NB also highlights that its members account for 81% of MDR certificates and 95% of IVDR certificates issued across the European market.
“Notified bodies had more than enough resources to meet market needs. Now they have too many.”
The full survey results, in graphical format, are available on the Team-NB website: http://www.team-nb.org/documents-2025/