Consent to Supply Medical Devices Not Meeting Essential Principles – TGA Transitional Provisions

Background and Transition Context

To facilitate the transition from the EU Medical Devices Directive (MDD)/Active Implantable Medical Devices Directive (AIMDD) to the EU Medical Device Regulation (MDR), the TGA introduced provisions allowing continued supply of certain legacy devices in Australia. Devices that do not fully meet the updated Essential Principles (aligned with MDR changes) may receive consent to supply under section 41HB of the Therapeutic Goods Act 1989, provided specific conditions are satisfied. This mechanism helps prevent supply disruptions for critical devices while manufacturers progress toward full MDR compliance. Source: Consent for medical devices that do not meet Essential Principles - TGA

Eligibility Criteria for Consent

Consent may be granted if all the following are met:

• The device holds a valid certificate issued under MDD or AIMDD by an EU notified body.
• The certificate benefits from extended transitional validity under EU MDR Article 120 (as amended).
• No serious safety issues, restrictions, or prohibitions apply to the device.
• Continued supply is necessary to avoid genuine shortages or significant health impacts in Australia.
• The manufacturer/sponsor demonstrates that the device continues to meet core safety and performance requirements despite any non-compliance with updated Essential Principles.
• Robust post-market surveillance and risk management measures are in place.

Application Process

• Submit a formal application to the TGA, typically via the eBusiness Services portal.
• Required supporting documents include:
  • Copy of the valid MDD/AIMDD certificate.
  • Technical documentation summary showing ongoing compliance with essential safety/performance aspects.
  • Justification of shortage risk and public health impact if supply ceases.
  • Risk assessment addressing areas of non-compliance with updated Essential Principles.
  • Detailed post-market surveillance plan and commitment to TGA vigilance reporting.
• TGA evaluates applications case-by-case, balancing supply continuity against safety risks.

Conditions Attached to Consent

• Consent is temporary and linked to the device's EU transitional validity period.
• The device must continue to comply with TGA labelling, advertising, and reporting obligations.
• Sponsors must actively monitor for emerging risks and promptly report any adverse events or changes.
• TGA may impose additional conditions, such as enhanced monitoring, restricted supply channels, or periodic status updates.
• Consent does not equate to full regulatory approval and may be revoked if conditions are not met.

Practical Implications and Scope

This consent pathway primarily applies to legacy higher-risk devices (e.g., Class IIb implantable, Class III) with valid MDD/AIMDD certification that have not yet achieved full MDR certification. It reflects TGA's proportionate, risk-based approach during the global regulatory transition, prioritizing patient access to essential devices without compromising core safety standards.

Detailed eligibility checklists, application templates, examples of supporting evidence, and updates on transitional arrangements are available in the official TGA guidance on consent for medical devices that do not meet Essential Principles. Source: Consent for medical devices that do not meet Essential Principles - TGA

These provisions support supply stability while encouraging timely alignment with modern regulatory standards.