Q&A: Obligation to inform in case of interruption or discontinuation of supply

The European Commission's Regulation (EU) 2024/1860 introduces critical updates to EU medical device regulations, including the gradual implementation of Eudamed, a central database to enhance the traceability and safety of medical devices and IVDs. These updates aim to ensure supply chain continuity by mandating manufacturers and suppliers to promptly notify healthcare professionals and authorities about any supply disruptions or discontinuations. Transitional provisions for certain IVDs provide a smoother compliance path under the amended MDR and IVDR frameworks, reducing the risk of device shortages while maintaining healthcare product availability and improving market transparency.