As of the February 25, 2021, the December 2019 amendment of the Therapeutic Goods (Medical Devices) Regulations 2002 relating to the regulation of personalized medical devices was enacted. Of the most notable changes, the regulatory amendments introduced include:
Until now, devices deemed “custom devices” had been exempt from ARTG inclusion and since 2016 have been progressively integrated into the TGA regulatory framework. The old definitions of custom device, however, lead to varying interpretations in the field and several devices that had the potential to be personalised to a prescription or a specific clinical case were generally accepted as “custom-made devices.”
Under the new amendment, new definitions are introduced. The over-arching family is “Personalised medical devices” with four sub-categories defined:
Devices that meet the new definition of a “custom-made” medical device are now limited to rare, one-off, bespoke pieces that are designed and manufactured for patients whose treating health professional has determined that the patient’s anatomical or physiological features, or pathological condition, make them unsuitable candidates for patient-matched or adaptable medical devices that are included in the ARTG.
Devices that are designed using a pre-validated design envelope or produced via a repeatable and validated production process are generally no longer viewed as custom devices and will now need to be included in the ARTG.
This has significant implications for manufacturers as most devices previously supplied using the custom-made medical device exemption, no longer meet this definition and need to be included on the ARTG as patient-matched medical devices by November 1, 2024 (if eligible for the transition period).
Manufacturers that have been supplying a kind of custom-made device before February 25, 2021, should have already notified the TGA that they have been supplying that kind of custom-made device via the TGA online form. Any kind of custom-device supply which was not declared prior to the February 25, 2021 deadline will be deemed as being released post-implementation date of the new rule and immediately subject to the new regime and registration requirements.
In order to be eligible for the transition period (ending November 1, 2024), manufacturers must also submit a notification to access the transition arrangement for their re-classified patient-matched devices by August 25, 2021.
Devices that no longer meet the definition of “custom-devices,” and which are now deemed “patient-matched,” will need to be re-classified by their manufacturer under Schedule 2 of the Therapeutic Goods (Medical Devices) Regulations 2002 and subject to the relevant conformity assessment procedure prior to ARTG entry by the end of the transition period on November 1, 2024.
For certain devices, manufacturers may require consolidation of their supporting technical file (e.g. clinical evidence) and potentially be required to implement a quality management system, which meets all necessary provisions prior to conformity assessment.
Custom-made devices previously supplied as part of procedure kits may also be impacted. As “patient-matched” devices are no longer exempt from ARTG entries, the license structure of re-classified devices included in a kit should be reviewed for implications. In some cases, a separate ARTG may be required to cover the “patient-matched” device.
A TGA Guidance document was published in December 2020 to help manufacturers navigate through these changes and help communicate the manufacturer’s new obligations as the supplier of personalised medical devices. Manufacturers should ensure they have transition plans in place to continue meeting the requirements of the TGA framework.
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