The European IVDR device registration changes impact IVDs manufactured in Europe. These changes bring medical device quality certification, registration into line with practices already adopted in other parts of the world (especially north America and Australia). In Australia, the TGA set a legislated deadline of 26th May 2022 as date from which new product registrations would need to comply with the IVDR requirements. From that date local suppliers of devices manufactured in Europe were required to provide new certificates of conformity to show their manufacturer complied with IVDR. However, the COVID pandemic has severely disrupted the implementation of IVDR in Europe and transition to IVDR has been delayed. In recognition of this the TGA has had the legislation modified to expend the deadline to 26th May 2023.
All local suppliers should be working closely with their European manufacturers to ensure they can meet the deadline.
Products currently in the market with valid ARTG inclusions have until the expiration of that certificate to comply.
The Legislation and explanatory notes are attached
Therapeutic Goods Amendment Determination 2022