IVDR Transition Timelines Extended
On 9 July 2024, the Regulation (EU) 2024/1860 was published in the Official Journal of the European Union (OJEU) with immediate effect.
The IVDR replaced the IVDD and entered into force on 26 May 2017 with 26 May 2022 as date of application. On March 2023, the IVDR was amended as regards to transitional provisions for certain in vitro diagnostic (IVD) medical devices on Article 110(4) with the removal of the sell-off period to prevent unnecessary disposal of safe in vitro diagnostic medical devices that are still in the supply chain by means of (EU) 2023/607. On 9 July 2024 (EU) 2024/1860 has been published in the Official Journal of the European Commission and amends and further extends the transitional periods laid down in the IVD Regulation.
Only legacy devices, meaning devices covered by a certificate issued by 26th May 2022 or declaration of conformity drawn up before 26 May 2022 under the IVD Directive, and considered valid by virtue of Article 110 3a and 3b, may benefit from the extended transition period if:
If the above requirements are fulfilled, depending on the risk class of the device, the transition period is extended to:
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