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New Regulation Amendments to Personalised and Custom Medical Devices

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The Australian Government has made amendments to the regulation of personalised medical devices, including custom-made medical devices and 3D printed devices. This follows the Therapeutic Goods Administration (TGA) consultation processes conducted in 2017 and 2019. Copies of the submissions and a summary of the feedback to the consultations are available on the TGA website.

About the regulatory changes

Minister Hunt has agreed to delay the commencement of the Therapeutic Goods Legislation Amendment (2019 Measure No 1) Regulations 2019, Schedules 1, 2 and 3 that implement changes for a number of devices to be reclassified, modernised, to clarify and improve the way custom made devices and software as a medical device are regulated. This will delay commencement from 25 August 2020 to: 

  • 25 November 2021 for reclassification of certain devices (allowing commencement to be timed for six months after the changed date for implementation of new EU Medical Device Regulations),
  • 25 February 2021 for medical device software, and
  • 25 February 2021 for personalised medical devices (including 3D printed devices). 

Amended regulations

  • Updated definitions for personalised medical devices that allow for the distinction between different design and production methodologies, depending on the level of health professional oversight;
  • Improved TGA oversight of facilities that manufacture personalised medical devices;
  • Introduction of the concept of a Medical Device Production System (MDPS) and a related framework that allows healthcare professionals to produce personalised devices for treating their patients without the need for manufacturing certification;
  • Updates to the Essential Principles to clarify what information must be supplied (to patients) with a personalised medical device; and
  • Updates to the classification rule for medical devices that record diagnostic images to capture a broader range of technologies now being used for this purpose such as 3D-printed models.

An overview of the regulatory changes is also available on TGA website.

You may wish to sign up to TGA Updates in order to be notified of new web content as it becomes available.

More detail about the definitions and transition arrangements

There are now four different definitions; custom-made medical device, patient-matched devices, adaptable medical devices, and medical device production system (MDPS). Each of these categories will have specific requirements under the regulations as outlined below.

1.Custom-made devices

The current exemption for these devices will continue to apply if the new definition of “custom-made” comes into effect. The new requirements for custom-made devices (except where the request for manufacture from a health professional was made prior to this date), includes:

  • annual reporting of custom-made devices;
  • allowing the TGA to inspect production facilities;
  • documentation about the device to be retained for certain periods; and
  • manufacturers to provide information about each custom-made medical device to the intended recipient.

2.Patient-matched devices

Under the new definition, “patient-matched medical devices” (for those custom-made devices that will be patient-matched medical devices under the new definition), a transitional exemption provision will apply. Guidance on this notification procedure will be provided soon.

3.Adaptable medical devices

The regulation of adaptable medical devices will not change.

4.Medical device production system (MDPS)

The MDPS is a new category of medical device which will allow healthcare providers to produce personalised devices for treating their patients, without the need for manufacturing certification. MDPS can include devices such as 3D printers, associated software, and resin that is intended by its manufacturer to be used by a dentist to produce dental crowns. In these cases:

  • the MDPS itself will be treated as a medical device;
  • health professionals or persons within a healthcare facility who use the MDPS (e.g., a dentist) will not be classified as a manufacturer under the Therapeutic Goods Act 1989; and
  • sponsors will be able to include MDPS on the Australian Register of Therapeutic Goods (ARTG) after 25 August 2020.  

Compliance with the new regulations

Class I custom-made and patient-matched devices, refer to only therapeutic goods meeting the updated definition of custom-made devices and will continue to remain exempt under the amendments introduced to the Therapeutic Goods (Medical Devices) Regulations 2002. Transitional arrangements have been put in place to ensure that manufacturers and suppliers of what will become ‘patient-matched’ devices can continue to supply these devices while they apply for inclusion in the Australian Register of Therapeutic Goods (ARTG).

Accessing the transitional arrangements will extend the deadline for ARTG-inclusion to 1 November 2024. The TGA are currently finalising guidance around the changes and what manufacturers and suppliers need to do from here. This is will be published soon, if you have any questions on this matter please contact ATSA or the TGA directly.

In the meantime, the Medical device inclusion process section of the Australian Regulatory Guidelines for Medical Devices (ARGMD) is a great source of information and resources relevant to including a Class I device on the ARTG.

Some of these devices will require a conformity assessment depending on the classification that the device falls in. Manufacturers may already have suitable evidence of conformity assessment certification from comparable overseas regulators that will meet regulatory requirements. This includes the EU Medical Device Directive (MDD) or EU MDR conformity assessment certificates.

Amendments to the Essential Principles in the Australian Medical Device Regulations and their implementation are also proposed to be delayed for up to two years after the commencement of European Union Medical Device Regulation changes (i.e. May 2023) and IVD Medical Device Regulations – this is still to be confirmed by the European Parliament, but is likely to be May 2022, so two years after that date.

This would provide time for industry to adjust to the EU regulations and to allow consideration of similar changes in the Australian context and ensure that the transition in Australia is implemented effectively.

Further information about the reforms will continue to be published on the TGA’s website, with the TGA also working closely with stakeholders to identify opportunities for continued consultation on guidance material over the coming months.

Several submissions to the TGA 2019 consultation highlighted the issue of how assistive technology for people with disabilities would be considered under the regulatory changes. The TGA consultation on products used for and by people with disabilities examined possible changes to the excluded goods determination on assistive technologies.  Consultation closed in late October 2019, and submissions have been reviewed. Unfortunately, this work has been impacted by the COVID-19 situation. It is currently with TGA Legal Services and will be circulated to ATSA and other stakeholders for comment prior to submission to the Government for consideration of policy approval.

If you have any questions in relation to the information provided above please contact devicereforms@health.gov.au or David.Sinclair@atsa.org.au

Alexandria EvansNew Regulation Amendments to Personalised and Custom Medical Devices

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