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January 22, 2026
Approximately 5 minutes
TGA Actions to Address EU MDR-Related Medical Device Supply Shortages
TGA Actions to Address EU MDR-Related Medical Device Supply Shortages
Background
- EU MDR (2017/745) and IVDR (2017/746) impose stricter certification requirements.
- Many manufacturers ceased supply to smaller markets like Australia due to compliance costs.
- This created risk of shortages for essential and legacy devices.
Key TGA Measures
- Time-limited exemptions (s41HB):
- Allow continued supply of devices with valid EU certification without full Australian conformity assessment.
- Granted case-by-case for high-need or shortage-risk devices.
- Limited duration until full compliance or alternative supply available.
- Prioritised conformity assessment:
- Fast-track TGA applications for devices at risk of discontinuation.
- Reduced documentation for legacy devices with established safety.
- Acceptance of EU notified body data where appropriate.
- Supply monitoring:
- Public list of devices at risk of shortage.
- Regular engagement with sponsors and stakeholders.
- Guidance on alternative sourcing and transition plans.
- Transitional alignment:
- Align select EU extension arrangements when safety not compromised.
- Support sponsors towards full compliance.
Application for Exemptions
- Submit via TGA portal with:
- EU certification evidence
- Discontinuation rationale
- Risk mitigation plan
- Clinical need/shortage impact assessment
- TGA assesses public health risk and may impose conditions (e.g. enhanced vigilance).
Important Notes
- Exemptions are temporary; full compliance required eventually.
- TGA may revoke if new safety issues emerge.
- Sponsors must promptly report supply changes or shortages.
- Healthcare providers/patients encouraged to report issues.
Full details on eligibility, forms, priority pathways, current exemption lists, and updates are in the TGA guidance on managing EU-related medical device supply disruptions. Source: How we are managing medical device supply disruptions resulting from changes in Europe - TGA
These steps help ensure continued access to critical devices during the global regulatory transition.
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