Medical Devices Transitioning from EU MDD to EU MDR - Sponsor Notification and Obligations
The TGA has implemented a transition pathway for non-IVD medical devices currently included in the ARTG that need to transition from the EU Medical Device Directive (MDD) to the new EU Medical Device Regulation (MDR). Sponsors or agents must complete notification forms and use the provided tool to determine required actions for continued supply in Australia.
Manufacturers and sponsors placing medical devices on the Australia 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 ↗