On July 09 2024, Regulation (EU) No 2024/1860 has been published.
This Regulation introduces the following key changes:
– a gradual roll-out of Eudamed,
-the obligation to inform in case of interruption or discontinuation of supply,
-transitional provisions for certain in vitro diagnostic medical devices
Only IVDD legacy devices may benefit from the extended transition period if:
The device continues to comply with IVDD requirements:
– There are no significant changes in design or intended purpose or the device.
– The device does not present an unacceptable risk to the health and safety of patient.
– The manufacturer has implemented an IVDR compliant QMS no later than 25 May 2025.
– The manufacturer has lodged a formal application with a NB by May 2025 for class D devices, by May 2026 for Class C devices and by May 2027 for class B and A-Sterile devices.
– The manufacturer has signed a written agreement with an NB by September 2025 for class D devices, by September 2026 for Class C devices and by September 2027 for class B and A-Sterile devices.
If the above requirements are fulfilled, the transition period is extended to:
– 31 December 2027 for Class D devices
– 31 December 2028 for Class C devices
– 31 December 2029 for Class B and A-Sterile devices
For detail information on transtion requirements and periods of IVDR, please consult our experts.