EU MDR transition extension

The TGA recently implemented an EU MDR transition strategy for Australian medical device sponsors and stakeholders. More recently, the EU extended the transition, prompting the TGA to review its strategy, and to review the impact on reclassification reforms underway in Australia.

The TGA recently implemented an EU MDR transition strategy for Australian medical device sponsors and stakeholders. More recently, the EU extended the transition, prompting the TGA to review its strategy, and to review the impact on reclassification reforms underway in Australia……READ MORE