Medical Devices
(BRUSSELS) – The EU Council endorsed Wednesday key updates to the law on medical devices, intended to help prevent shortages and ease the transition to greater transparency and access to information.
The regulation approved by EU member-state representatives amends legislation on medical devices, including in-vitro diagnostic medical devices (IVDs), by extending the transition period for certain IVDs (particularly those that are high-risk), enabling a gradual roll-out of EUDAMED, the new electronic database and requiring manufacturers to flag up potential shortages of critical medical devices and 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 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 extends the deadline for transitioning to the new system under certain conditions, to avoid shortages of critical IVDs without compromising on safety.
In a bid 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.
To speed up the process of registering medical device data, manufacturers will now be required to provide information about their products via the completed EUDAMED modules. This mandatory registration is expected to take effect from late 2025.
The new revision 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 new compromise agreement will be formally adopted by the European Parliament and the Council following legal-linguistic revision.
