Regulation (EU) 2023/607 - Extended Transition Periods for Medical Devices
Introduces staggered extension of transition periods for MDR subject to specific conditions and removes the 'sell-off' deadline for devices already in supply chain. Applies to both MDR and IVDR.
📅 Effective / published: 2023-03-15
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 ↗