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

The European Commission has issued a vital update regarding the obligation for manufacturers and suppliers of medical devices and in vitro diagnostic (IVD) medical devices to inform stakeholders in the event of supply interruptions or discontinuations. This update, introduced by Regulation (EU) 2024/1860, amends the existing frameworks of Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR), and aims to ensure greater transparency and continuity in the supply chain of critical medical devices across Europe.

One of the key aspects of this update is the gradual implementation of Eudamed, the European database for medical devices. As a central system for collecting and sharing information about medical devices, Eudamed enhances the traceability and safety of devices across Europe. The update also imposes new information obligations for manufacturers and suppliers in cases of disruptions or cessation of supply. This ensures that healthcare professionals and relevant authorities are promptly notified about any significant changes in device availability that could impact patient care or treatment.

Additionally, the update introduces transitional provisions for certain IVDs, allowing manufacturers to gradually comply with the new regulatory requirements while minimizing the risk of device shortages. These provisions are designed to ensure that the transition to the new rules does not disrupt the market or affect the availability of essential healthcare products.

This update emphasizes the need for manufacturers, healthcare professionals, and device suppliers to stay informed and comply with the new requirements. Awareness and prompt action are essential to maintain a smooth supply of medical devices and IVDs in the European market. For further details, the European Commission's full document is available, providing a comprehensive understanding of these changes and how they will affect stakeholders.