TGA's EU MDR Transition Market Notification Web Publication Service

1. Background and Purpose

The EU Medical Devices Regulation (EU MDR) imposes stricter requirements on medical devices, with a transition deadline of 26 May 2024 for certification from the previous EU Medical Devices Directives (EU MDD). To address potential supply disruptions in Australia due to certification delays, the TGA introduced a web publication service for market notifications. This service supports sponsors in communicating low-risk changes related to the transition or supply cessation to healthcare providers and consumers, adopting a risk-based approach to minimize regulatory burden. Source: https://www.tga.gov.au/products/regulations-all-products/tga-reforms/eu-mdr-transition/eu-mdr-transition-web-publication-service

2. Eligibility Criteria

Eligibility for using the web publication service requires meeting all six criteria for transitioning devices:

• Changes are solely due to EU MDR regulatory requirements, not safety or defect issues.
• Devices complied with Australian requirements when supplied.
• No deficiencies in safety, quality, performance, or presentation of currently supplied devices.
• Changes not resulting from safety incidents causing harm.
• Changes not from adverse event reports or investigations.
• Devices manufactured while the conformity assessment certificate was valid. The service also covers notifications for non-transitioning devices where supply will cease in Australia. Source: https://www.tga.gov.au/products/regulations-all-products/tga-reforms/eu-mdr-transition/eu-mdr-transition-web-publication-service

3. Application Process

Sponsors submit notifications through the TGA's online consultations portal for low-risk changes. Submissions are accepted until 11:59pm on Sundays, with updates published weekly on Tuesdays if new submissions are received. Alternatively, sponsors may directly notify healthcare providers or end users and maintain verifiable documentation for TGA requests. Source: https://www.tga.gov.au/products/regulations-all-products/tga-reforms/eu-mdr-transition/eu-mdr-transition-web-publication-service

4. Required Documentation

Notifications published via the service include details of changes. A supporting Excel file lists market notifications as of 5 January 2026, available for download (135.73 KB). Sponsors must ensure submissions are complete and accurate. Source: https://www.tga.gov.au/products/regulations-all-products/tga-reforms/eu-mdr-transition/eu-mdr-transition-web-publication-service

5. Implications and Limitations

The service is limited to low-risk changes and does not address safety concerns; for any deficiencies, incidents, or harm, sponsors must use separate recall or post-market actions to contact providers and consumers directly. It promotes transparency during the transition, helping maintain supply chains without compromising safety. Source: https://www.tga.gov.au/products/regulations-all-products/tga-reforms/eu-mdr-transition/eu-mdr-transition-web-publication-service

6. Related Guidance and Updates

The page was last updated on 5 January 2026. Related resources include broader EU MDR transition guidance on the TGA site. The submissions portal is accessible at https://consultations.tga.gov.au/tga/ef19f496/. Sponsors should note that safety issues require separate handling. Source: https://www.tga.gov.au/products/regulations-all-products/tga-reforms/eu-mdr-transition/eu-mdr-transition-web-publication-service

7. Practical Considerations

This temporary measure aligns with EU MDR transitional provisions and emphasizes that notifications do not substitute for full compliance. Sponsors are responsible for ensuring changes do not impact device safety or performance. For complex cases, consulting TGA guidance is recommended. Source: https://www.tga.gov.au/products/regulations-all-products/tga-reforms/eu-mdr-transition/eu-mdr-transition-web-publication-service