TGA Medical Device Recalls and Market Notifications: Processes and EU MDR Transition

1. Overview of Recalls and Market Notifications

The Therapeutic Goods Administration (TGA) oversees recalls and other market actions for medical devices supplied in Australia. These actions address deficiencies or defects related to safety, quality, performance, or presentation of devices already on the market. The primary goal is to resolve issues through structured processes outlined in the Uniform Recall Procedure for Therapeutic Goods (URPTG). Source: https://www.tga.gov.au/products/medical-devices/monitoring-and-compliance/recalls-and-market-notifications

Market actions ensure continued compliance and protect public health.

2. Types of Market Actions

Sponsors can undertake four main types of actions:

• Recall: Removal of devices from supply or use
• Product defect correction: On-site correction of supplied devices
• Hazard alert: Information about risks for implanted or critical devices
• Product defect alert: Information about defects without recall or correction Source: https://www.tga.gov.au/products/medical-devices/monitoring-and-compliance/recalls-and-market-notifications

These follow standard procedures detailed in the URPTG.

3. Streamlined Notifications During EU MDR Transition

For changes related to the transition from EU Medical Device Directive (MDD) to Medical Device Regulation (MDR), eligible sponsors can use streamlined market notifications instead of full recall procedures. Eligibility requires meeting all six criteria:

• Changes solely due to EU MDD to MDR transition
• No safety, quality, performance, or presentation deficiencies
• Devices continue to comply with Australian requirements
• No reported safety-related incidents causing harm
• No adverse event signals
• Valid conformity assessment certificate Source: https://www.tga.gov.au/products/medical-devices/monitoring-and-compliance/recalls-and-market-notifications

Eligible sponsors notify customers directly, maintain records, and provide documentation to TGA upon request.

4. Processes for Non-Eligible Changes

If criteria are not met (e.g., safety-related issues or high-risk changes), sponsors must follow standard recall procedures, including submission of recall notifications to TGA. An Online Notification Form is available for submissions. Source: https://www.tga.gov.au/products/medical-devices/monitoring-and-compliance/recalls-and-market-notifications

Sponsors must also notify when ceasing supply of non-transitioning devices.

5. Sponsor Obligations

Sponsors are responsible for:

• Notifying TGA and customers promptly
• Maintaining documentation of all market actions
• Using TGA's EU MDR Transition web publication service for notifications to healthcare providers and end users
• Providing information upon TGA request Source: https://www.tga.gov.au/products/medical-devices/monitoring-and-compliance/recalls-and-market-notifications

Case studies and scenarios are available to guide compliance.

6. Consumer and Healthcare Professional Information

Consumers and professionals receive notifications from sponsors about changes or actions. The TGA publishes information on recalls and safety alerts. Patients should discuss any concerns with healthcare providers and report adverse events. Source: https://www.tga.gov.au/products/medical-devices/monitoring-and-compliance/recalls-and-market-notifications

7. Related Resources and Ongoing Support

Key resources include:

• Uniform Recall Procedure for Therapeutic Goods (URPTG)
• General recalls information page
• Online Notification Form
• EU MDR Transition web publication service
• Supporting case studies PDF Source: https://www.tga.gov.au/products/medical-devices/monitoring-and-compliance/recalls-and-market-notifications

The TGA continues to support the transition while ensuring device safety.