TGA have been published new document very helpful and interesting about EU MDR Transition –Recalls and market notifications
Case studies and scenarios
Version2.1,February2024
Introduction
This guidance covers case studies and scenarios about recalls and market notifications for manufacturers and sponsors transitioning their ARTG entries to the EU MDR certification.
This guidance is to be read in conjunction with the guidance EU MDR Transition – Overview and management under the Australian regulatory framework – guidance for manufacturers and sponsors available on the TGA website.