Consultation: Proposed changes to the IVD medical device classifications and definitions

While the consultation is open you can make a submission at our TGA consultation hub - external site. We then review the submissions. After that the submissions and our decision will be available on the same page at the TGA consultation hub - external site.

About this consultation

We are seeking stakeholders’ feedback on proposed changes to the IVD medical device classifications and definitions.

This consultation aims to confirm views on aligning classification rules, principles, and definitions with the European Regulation 2017/746 for in vitro diagnostic medical devices (IVDR) where appropriate. The proposed changes include:

• Australian classification rules and principles that classify IVD devices in proportion to the health risk posed by their intended purpose, technology, and use.
  • Adoption of certain terminology from the EU classification rules to enhance clarity and ensure the rules encompass new and emerging technologies.
  • Increased clarity on specific IVD terms currently not defined in the Australian Regulations.

This consultation does not address the Australian classification rule 1.4 for self-tests. The TGA plans to conduct a separate consultation to review the regulatory controls for IVD self-tests.

For any questions relating to this consultation, please email us at IVDs@tga.gov.au.

All recent TGA consultations can be found at the TGA consultation hub - external site.