Regulation (EU) 2024/1860 - Extension of Transition Periods and Eudamed Roll-out
Amends MDR and IVDR to extend transition periods, implement gradual roll-out of Eudamed database, and introduce information obligations for supply interruptions or discontinuation. Includes staggered implementation timeline for in vitro diagnostic devices.
📅 Effective / published: 2024-06-13
Manufacturers and sponsors placing medical devices on the the EU market should review their current compliance documentation against this change. Assess whether your device class, labelling, registration status, or technical documentation is affected. Where gaps are identified, update your files and notify your local representative or importer. Refer to the official source below for the full regulatory text and any transitional arrangements.
View official source ↗