Approved by European Union (EU) member-state representatives, the new regulations amend legislation on medical devices, including in-vitro diagnostics (IVDs). Amendments include the extension of the transition period for certain IVDs — especially those considered high-risk, a gradual roll-out of the electronic European database on medical devices (EUDAMED), and requiring manufacturers to flag potential shortages of critical medical devices and IVDs.
Extension of the transition period for certain IVDsThe extension of the transition period for certain IVDs relates to a 2017 decision called the In Vitro Diagnostic medical Device Regulation (IVDR) and was adopted together with the Medical Devices Regulation (MDR). Part of the IVDR changes included the introduction of new rules to modernize and update the EU framework for IVDs to guarantee safety and effectiveness. The far-reaching changes have “led to increased need to scientific, technical, and regulatory expertise,” according to the council, which has reportedly taken time to develop. As a result, many IVDs have not yet been able to comply with the new rules, meaning that they could be removed from the market without replacement once the transition period ended. This recent revision extends that deadline. European database on medical devicesAlso rolled out in the 2017 regulations, new rules to improve transparency and access to information were announced, leading to the creation of the European Database on Medical Devices (EUDAMED), which would eventually contain comprehensive data on all medical devices available on the European market. While manufacturers were initially not required to register their medical devices on the electronic database until all of its six (6) elements or modules were set up, their completion is unlikely to be completed until late 2027. In order to speed up the process for registering, the council will now require manufacturers to provide information about their products on the currently available modules. The new rule is expected to take effect in late 2025. Flagging potential shortagesThe new measures recently decided by the council also include 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,” according to the press release announcing the revisions. The agreement will be formally adopted by the European Parliament and the EU Council following linguistic revision. REFERENCE: MD&DI (Medical Device and Diagnostic Industry); 27 FEB 2024; Katie Hobbins