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

Overview

The Therapeutic Goods Administration (TGA) is 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.

The consultation paper will be available for public comment for two months (12 March 2025 – 8 May 2025). Submissions in response to the consultation paper can be made through the online survey link below during this time period.

You can right click on the consultation paper below and open a new tab to access the paper while going through the online survey.

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