TGA Consultation on Changes to Australian Medical Device Essential Principles
The TGA is now calling for public consultation on proposed changes to the Australian medical device Essential Principles (EPs).
In 2019, the TGA undertook consultation on changes to the EPs for safety and performance, with feedback indicating support for alignment with the General Safety and Performance Requirements (GSPR) of the European Regulations.
The current consultation seeks to confirm views on where EPs should align with the GSPR of the European Regulation 2017/745 on medical devices (MDR) and Regulation 2017/746 for in vitro diagnostic medical devices (IVDR).
Consultation closes 16 October 2024.
Download the consultation paper and associated attachment.
The TGA will also be hosting two webinars to overview the consultation and provide an opportunity for stakeholders to ask questions on the consultation. For more information, see listings for the 11 September 2024 and 12 September 2024 webinars.
For any further questions, email the TGA Device Reforms team.