TGA UDI Requirements for Medical Devices Commence in Australia
From 1 July 2026, certain medical devices supplied in Australia must meet TGA Unique Device Identification requirements, starting with Class IIb and Class III devices.
European Commission Expands List of Class IIb Implantable Devices Exempt from Individual Technical Documentation Assessment
The European Commission expands the list of Class IIb implantable devices exempt from individual technical documentation assessment under MDR Article 52(4).