The Council of the EU has formally adopted new rules updating the law on medical devices in order to help prevent shortages and ease the transition to greater transparency and access to information.
The newly adopted regulation updates the legislation on medical devices, including in-vitro diagnostic medical devices (IVDs), by:
- further extending the transition period for certain IVDs
- enabling a gradual roll-out of EUDAMED, the new electronic database
- requiring manufacturers to flag up potential shortages of critical medical devices and IVDs.
The amendment adopted today – which was first proposed in January 2024 - extends the deadline for transitioning to the new system under certain conditions, to avoid shortages of critical IVDs without compromising on safety.
The new regulation also enables a gradual roll-out of the European Database on Medical Devices (EUDAMED) by requiring manufacturers to provide information about their products to existing EUDAMED modules without needing to wait for the remaining modules to be completed. This mandatory registration is expected to take effect as of late 2025.
Today’s revision also introduces an obligation for manufacturers to give prior notice about any interruption of supply of certain critical medical devices or IVDs to relevant authorities, health institutions, healthcare professionals and economic operators to whom they supply the device.
The full text of the updated regulation can be accessed at https://data.consilium.europa.eu/doc/document/PE-54-2024-INIT/en/pdf