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Update on reforms - Personalised medical devices

June 23, 2020

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

Regulatory changes – an overview

The regulatory changes include the introduction of new classification rules which come into effect on 25 August 2020. The regulatory changes include:

  • 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 their website.

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.

Custom-made devices

The current exemption for these devices will continue to apply if the new definition of custom-made which comes into effect on 25 August 2020 is met. 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.

Patient-matched devices

The new definition, patient-matched medical devices will come into effect on 25 August 2020. For those custom-made devices that will be patient-matched medical devices under the new definition, a transitional exemption provision will apply from 25 August 2020 to 1 November 2024 if a notice is submitted to the TGA by 25 February 2021. Guidance on this notification procedure will be provided soon.

Adaptable medical devices

The regulation of adaptable medical devices will not change.

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 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

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.

Given the recent announcement by the EU Parliament to delay the implementation of the EU Medical Device Reforms and the impact of COVID-19 to the ability of manufacturers to prepare adequately for the regulatory changes, the TGA is currently analysing the impact this may have on current timeframes for personalised medical device compliance in Australia.

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affecting Health Care practitioners in the Darling Downs and West Moreton Regions: