Adopted on 13 June 2024 and published in the Official Journal of the European Union on 9 July 2024, Regulation (EU) 2024/1860 amends both the Medical Device Regulation (MDR) 2017/745 and the In Vitro Diagnostic Regulation (IVDR) 2017/746. A central change concerns EUDAMED — the European Database on Medical Devices — which will now be rolled out module by module as each component passes an independent audit, rather than waiting for the entire database to be complete. This phased EUDAMED approach is intended to improve transparency and traceability on the EU market without further delay.

The regulation also extends the IVDR transitional period for higher-risk in vitro diagnostic devices (IVDs), particularly legacy devices previously certified under Directive 98/79/EC. Manufacturers wishing to benefit from this extension must meet specific conditions, including establishing a quality management system by 26 May 2025 and submitting a formal application for IVDR certification to a notified body. This ensures that devices remaining on the market during the transition continue to meet high safety standards.

Finally, Regulation 2024/1860 introduces a new obligation requiring manufacturers and economic operators to notify competent authorities ahead of any interruption or discontinuation of supply of critical devices. Together, the phased EUDAMED rollout, the extended IVDR transitional provisions, and the new supply transparency obligations mark a significant step in the EU’s effort to balance patient safety with regulatory continuity across the medical device sector.