IVDR: transition period close to end, first deadline in May 2025
Just as Regulation (EU) 2023/607 had granted a transition period to comply with the requirements of Regulation (EU) 2017/745 on medical devices, Regulation (EU) 2024/1860 has amended the transition periods of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). The first deadline to comply with IVDR time extension is now close: as of 26 May 2025 some devices will lose their right to be put on the market if not compliant with the IVDR.
Main changes introduced
The application date of the IVDR is still fixed at 26 May 2022, but transitory provisions have been extended for devices requiring the involvement of a Notified Body.
For devices certified according to Directive 98/79/EC (IVDD), the transition period has been extended until the following deadlines:
- 31 December 2027 for class D IVDs
- 31 December 2028 for class C IVDs
- 31 December 2029 for class B IVDs
- 31 December 2029 for class A sterile IVDs
Beware: time extension is not automatic
However, the time extension is not automatic: article 2 of Regulation (EU) 2024/1860 establishes that, in order to be able to benefit of the transition period; devices must fulfil the following conditions: be still compliant with Directive 98/79/EC (IVDD) until their marketing; do not undergo any significant change in their design and intended use; the manufacturer must have started the IVDR certification process, demonstrating that they have submitted a formal application to a Notified Body within:
- 26 May 2025 for class D devices
- 26 May 2026 for class C devices
- 26 May 2027 for class B devices and class A sterile devices
and that they have signed a contract with the NB within:
- 26 September 2025 for class D devices
- 26 September 2026 for class C devices
- 26 September 2027 for class B devices and class A sterile devices.
If one of these requirements is not met, the device will lose its right to the time extension and shall comply with the IVDR to be marketed.
Who is excluded from the time extension
Class A devices, that do not need the involvement of Notified Body, must comply with the IVDR as of 26 May 2022.
“New” devices, i.e. those that have never been marketed according to Directive 98/79/EC, must comply with the IVDR as of the date of its application.
The deadline of 26 May 2025 is a first essential break in the IVDR transition period. Manufacturer of class D devices must get going immediately to ensure compliance, without waiting for the last minute.
In spite of the time extensions granted by Regulation (EU) 2024/1860, the time for compliance is about to expire: the companies of this sector must therefore act now to prevent the risk of disruptions in the marketing of their devices.
Di Renzo Regulatory Affairs is able to support IVD manufacturers in this delicate transition phase.
Thanks to the expertise of our team, we can offer assistance in all the certification and post-marketing steps, in the preparation of the documentation, in the PMS activities and in interfacing with notified bodies.
