Brussels, 21 February 2024
The Council has endorsed key updates to the law on medical devices that will help prevent shortages and ease the transition to greater transparency and access to information.
The regulation approved by EU member-state representatives today amends the legislation on medical devices, including in-vitro diagnostic medical devices (IVDs), by:
- further extending the transition period for certain IVDs (particularly those that are high-risk)
- enabling a gradual roll-out of EUDAMED, the new electronic database
- requiring manufacturers to flag up potential shortages of critical medical devices and IVDs
Helping to guarantee supply of critical IVDs
Around two thirds of all clinical decisions are based on information provided by IVDs, which include tests for HIV, cancer, pregnancy and COVID-19. In 2017, new rules were introduced to modernise and update the EU framework for these products, guaranteeing their safety and effectiveness.
The far-reaching nature of these changes led to an increased need for scientific, technical and regulatory expertise and capacity, which take time to develop. As a result, many critical IVDs have yet to comply with the new rules, leading to a risk that – once the transition deadline has passed – they may be removed from the market without being replaced.
The revision approved today extends the deadline for transitioning to the new system under certain conditions, to avoid shortages of critical IVDs without compromising on safety.
Gradual roll-out of EUDAMED
To improve transparency and access to information, the new rules adopted in 2017 provided for the creation of a European database on medical devices (EUDAMED), which would eventually contain comprehensive data about all medical devices available on the European market.
Initially, manufacturers were not required to register their medical devices on EUDAMED until all of its six elements (‘modules’) had been set up. However, while three modules are already available, and two more are expected to become available in 2024, the final module is unlikely to be completed until late 2027.
Therefore, in order to speed up the process of registering medical device data, manufacturers will be required under the new rules to provide information about their products via the completed EUDAMED modules. This mandatory registration is expected to take effect as of late 2025.
Flagging up potential shortages
The best way to prevent shortages of key medical devices is to catch them early. Today’s revision therefore 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
Today’s compromise agreement will be formally adopted by the European Parliament and the Council following legal-linguistic revision.
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 agreed on its mandate on 14 February 2024.
- Final text agreed with the European Parliament on amending the Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation
- The EU’s role in health policy (background information)
- EUDAMED database
Source – EU Council