Presentation: Medical Devices – Essential Principles for Safety and Performance - Part 2 Proposed alignment with the European Regulations

Background

This consultation paper seeks feedback on proposed changes to the Australian Essential Principles for Safety and Performance of medical devices (Essential Principles), to align, where appropriate, with changes being implemented in the European General Safety and Performance Requirements (GSPR). We are aiming to ensure the Essential Principles remain relevant, harmonised where appropriate and to identify opportunities for potential strengthening to improve safety and performance of medical devices in Australia. More information can be found at our consultation page.

Slides