European Parliament and Council sign new MDR/IVDR Amending Regulation

Regulation (EU) 2024/1860 includes changes to the device regulations in the areas of Eudamed roll-out, interruption of device supply, and transitional provisions for certain IVDs.

The regulation (and it’s almost immediate corrigendum) were mentioned in a press release from the Council of the European Union published on 30 May 2024, which identified that the regulation covered:

• further extending the transition period for certain IVDs
• enabling a gradual roll-out of EUDAMED
• requiring manufacturers to flag up potential shortages of critical medical devices and IVDs

The regulation entered into force following publication in the EU’s Official Journal on 9 July 2024.

The first three of the six EUDAMED modules are already available for voluntary use (Actor registration; UDI and device registration; Notified Bodies and certificates). As per the recent updates from European Commission, two other modules (vigilance and post-market surveillance; market surveillance) are expected to be completed in 2024 and these five modules are anticipated to be declared functional around mid 2025. The module covering clinical investigation / performance studies is not expected to be completed before Q3 2026. Details are in the updated roadmap published by the Commission.