Medical devices: Council adopts new measures to help prevent shortages
The Council has 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 regulation adopted today amends 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
Overview of the key changes
In 2017, new rules were introduced to modernise and update the EU framework for IVDs, guaranteeing their safety and effectiveness. The amendment adopted today 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.
Next steps
The regulation adopted today will enter into force following publication in the EU’s Official Journal.
Background
The In Vitro Diagnostic Medical Device Regulation (IVDR) entered into force in 2017 and has been applicable since 26 May 2022. It was adopted together with the Medical Devices Regulation (MDR), which has been applicable since 26 May 2021. The aim of these two regulations was to modernise the rules on medical devices, including IVDs, and improve patient safety.
Due to the far-reaching nature of the changes set out in the IVDR, a large number of IVDs currently on the market have yet to comply with the new rules; the situation is particularly serious for high-risk IVDs such as certain blood tests.
On 23 January 2024 the European Commission published a proposal to update the provisions of the IVDR and MDR with the aim of mitigating shortages of critical medical devices. The EU Council endorsed the compromise agreement reached with the European Parliament on 21 February 2024.