Conformity assessment, Essential Principles and consent to supply

It is a requirement that sponsors have a valid manufacturer evidence, accepted by the TGA, when making an application for inclusion in the ARTG or a DCR/variation application. The TGA will continue to accept valid EC certificates issued in accordance with the MDD or AIMDD until the extended transition period or the certificate expiry date, whichever occurs first. 

Sponsors must always ensure that, while the inclusion in the ARTG has effect, that they have available sufficient information to substantiate compliance with the essential principles, and that the conformity assessment procedures have been applied to the kind of medical device, and ensure compliance with all conditions applying automatically, and if applicable, any additional conditions imposed. If a sponsor determines that their medical devices manufactured under a valid conformity assessment certificate no longer comply with the Essential Principles, they must submit an application for consent to import, export, or supply medical devices that do not comply with the Essential Principles before they import, export, or supply the devices.

Medical devices can only be manufactured with a valid conformity assessment document in place. Sponsors who are supplying medical devices from a manufacturer that are transitioning from EU MDD to EU MDR may find that they hold stock that was manufactured under a valid MDD certificate, but the certificate has since expired.

 Medical devices that are included in the ARTG and were manufactured under a valid conformity assessment certificate can be supplied after the certificate has expired. Sponsors must notify the TGA within 60 days of becoming aware of the lapsing, revocation, suspension or cancellation of conformity assessment certification using the Lapses in Conformity Assessment Notification Form. The TGA may review the information provided to inform on whether the entries can remain included in the ARTG. Any decision made is on a case-by case basis. There are criminal and civil penalty sanctions if a sponsor fails to notify the TGA within 60 days of becoming aware that a conformity assessment document (other than a conformity assessment certificate issued by the TGA) has been restricted, suspended, revoked or is no longer in effect.

There are criminal and civil penalty sanctions if a sponsor imports, exports, or supplies non-compliant medical devices without consent. The TGA will continue conducting random post-market reviews in order to ensure that the devices in the ARTG continue to meet legislative obligations.

Automatic conditions

The legislation outlines the conditions that are automatically applied to a kind of device that is included in the ARTG. Refer to Part 4-5, Division 2 (Conditions) of the Act and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations 2002 for relevant information. You must ensure that you continue to comply with these conditions when transitioning to the EU MDR, including compliance with the Essential Principles. 

Inclusions in the ARTG may be subject to post market review to ensure compliance with these conditions. 

Essential Principles - consent to supply

There are criminal offences under section 41MA and civil penalties under section 41MAA of the Act, for persons who import, supply or export medical devices that do not meet the Essential Principles for safety and performance.

However, it is acknowledged that the transition to the EU MDR may present extenuating circumstances preventing compliance with one or more parts of an Essential Principle for a limited period.

In such circumstances, sponsors may request consent to import, supply or export medical devices which do not meet an Essential Principle.

Where consent to supply is granted for a medical device that is non-compliant with the Essential Principles, ongoing regulatory responsibilities of the sponsor remain, including but not limited to, undertaking recall actions, and reporting of adverse events.

The following illustration provides an overview of how the manufacture of devices and its journey through the supply chain is regarded: