Medical devices reforms: Personalised medical devices

Project overview

A new regulatory framework has been introduced, to manage the risks associated with personalised medical devices.

Before 25 February 2021, most personalised medical devices (PMD) met the definition of 'custom-made'. These were exempt from being included in the Australian Register of Therapeutic Goods (ARTG).

During the past two decades, technology changes have advanced:

• medical imaging,
• manufacturing, and
• medical devices.

Newer methods of manufacture such as 3D printing allowed higher-risk medical devices to be personalised and supplied under the custom-made medical device exemption.

New PMD regulations were developed after consulting with other global regulators. This new framework aims to make sure an appropriate level of regulation is applied to PMDs.

The new framework came into effect on 25 February 2021. It includes:

• New definitions for personalised medical devices, including patient-matched and adaptable medical devices
• Changes to the exemption for custom-made medical devices
• Requirements for the inclusion of Medical Device Production System (MDPS) in the ARTG.

Patient-matched medical devices (PMMDs)

Most devices previously supplied under the custom-made medical device exemption now meet the definition of a PMMD. The transition notification period for PMMDs ended 1 November 2024.

All PMMDs will continue to be exempt from ARTG inclusion until 1 July 2029. They can be manufactured and/or supplied until this date, regardless of whether a notification was made prior to 1 November 2024.

After 1 July 2029, all PMMDs (including notified PMMDs) must be included in the ARTG before they are:

• imported into,
• supplied within, or
• exported from Australia 

unless they are exempt, excluded or otherwise approved by us.

There will continue to be a 'low volume' exemption for PMMDs. As a result, the first five PMMDs of a kind supplied in a financial year by one entity will not require an ARTG inclusion.

Exempt devices are exempt from inclusion in the ARTG. They are not exempt from regulation. Manufacturers and sponsors of exempt medical devices still need to meet the Essential Principles and advertising requirements.

Medical Device Production Systems (MDPS)

MDPS are a new concept in medical device regulation. This is where an end-to-end system for the manufacture of medical devices can be included in the ARTG. This allows devices to be manufactured within healthcare facilities without needing to include them in the ARTG.

MDPS is defined in the Therapeutic Goods (Medical Devices) Regulations 2002. This definition will not take effect until a subsequent legislative instrument declaring an MDPS to be a medical device is in place.

This will be progressed following current work with the International Medical Device Regulators Forum (IMDRF).  This work is continuing.

Useful guidance

• How to submit a custom-made medical device notification
• Understanding personalised medical devices rules (including 3D-printed devices)
• Refinements to the Personalised Medical Devices Framework
• Advertising personalised medical devices in Australia

Consultations

For more information see Consultations and reviews.

More information

• Personalised medical devices
• Custom-made medical devices
• Point-of-care manufacturing of medical devices
• Dental Sector Working Group