By 26 September 2025, manufacturers of in vitro diagnostic devices (IVDs) classified as Class D under the EU In Vitro Diagnostic Medical Devices Regulation (IVDR) as well as devices covered by an IVDD CE Certificate must have a signed agreement with a notified body. This requirement follows two earlier provisions: manufacturers must have submitted their application and have an IVDR-compliant Quality Management System (QMS) in place by 26 May 2025.
This will allow manufacturers to place their Class D devices and devices covered by an IVDD CE Certificate on the market until 31 December 2027. Afterwards, an IVDR certification will be required.
Notified body application: who has to apply and when?
A notified body is a third-party organisation responsible for the conformity assessment of medical devices and IVDs placed on the EU market. With the exception of Class A devices, all IVDs must be certified by a notified body. For devices that were compliant with the previous Directive – now no longer in force – manufacturers may benefit for specific transitional periods granted under the IVDR (so called “legacy devices”).
IVDR transitional periods and application deadlines
The new transitional periods are:
- 31 December 2027 for Class D and devices covered by an IVDD CE Certificate
- 31 December 2028 for Class C
- 31 December 2029 for Class B and A sterile
The deadlines to apply with a notified body in order to benefit from the new transitional periods are:
- 26 September 2025 for devices covered by an IVDD certificate and for class D devices that were “self-declared” under the Directive (IVDD)
- 26 September 2026 for class C devices that were “self-declared” under the IVDD
- 26 September 2027 for class B and class A sterile devices that were “self-declared” under the IVDD.
How Obelis supports manufacturers with the transition
Either as European Authorised Representative or as EU partner, Obelis finds the right notified body for each manufacturer of medical devices and IVDs, apply on their behalf, and provide support throughout the application. This allows manufacturers to save time, focus on their business, and have a trusted partner in the EU.
Do you have any questions regarding the upcoming restrictions? Get in touch!
References:
European Commission (2024). Extension of the IVDR transitional periods. Retrieved on 21/08/2025.
Regulatory Intelligence & Innovation Department
22/08/2025