Proposed changes to IVD medical device classifications and definitions

Background

We are seeking stakeholders’ feedback on proposed changes to the IVD medical device classifications, principles and definitions, specifically views on aligning with the European Regulation 2017/746 for in vitro diagnostic medical devices (IVDR) where appropriate. The proposed changes include:

• 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.

Speaker

• Babak Latif, Senior Technical Evaluator and Policy Officer, Devices In Vitro Diagnostics Section, Medical Device Authorisation Branch, TGA

Slides

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