Regulation (EU) 2024/1860 Published Today

Regulation 2024/1860 formally extends the Article 110 transitional provisions in the IVDR, overriding the previous dates outlined under Regulation (EU) 2022/112. 

The extension allows qualifying legacy devices* to remain on the market for a longer period. Certain conditions apply, and deadlines vary depending on risk classification.

Regulation 2024/1860 also amends the MDR and IVDR to require:

• Introduction of Article 10a, which requires advance notice of potential disruption of critical products.
• Gradual roll-out of EUDAMED, i.e., as each module is published in the Official Journal of the EU, instead of all six modules requiring full functionality and release at the same time. The first four modules are expected to go into force starting January 2026.

More information on the new regulation is available here. 

*Devices that 1) held Notified Body issued IVDD CE Marking certificates on 26 May 2022, or 2) held valid IVDD CE Marking as self-certified on 26 May 2022, but were up-classed under the IVDR. Devices that were self-certified under both the IVDD and IVDR are not eligible. These devices should have transitioned to IVDR CE Marking by 26 May 2022.