Tool: Sponsor obligations for medical devices transitioning from the EU MDD to the EU MDR

Overview

This tool is for sponsors or agents of non-IVD medical devices included in the ARTG with a need to transition from the EU MDD to the new EU MDR to allow medical devices to continue to be supplied in Australia.

This tool will assist you to determine what actions you may or may not need to take as a result of changes to conformity assessment documents relevant to your medical devices as a result of the implementation of the European Union Medical Device Regulations (EU MDR).

Background

Most medical devices included on the ARTG are supported by EU MDD certification and will need to transition to the new EU MDR to allow medical devices to continue to be supplied in Australia.

A risk-based and streamlined approach is being adopted to transition ARTG entries from the EU MDD to EU MDR certification, to minimise regulatory burden, cost, and impact on supply, that does not compromise the safety, quality, or performance of medical devices supplied in Australia.

If actions or information is required, this tool is designed to inform you of the most appropriate actions to take and forms to use.

NOTE: Do not use this form if you are seeking information on In-Vitro Diagnostic (IVD) medical devices. A separate tool will be developed for IVD medical devices.