Eclevar Australia provides an update on Australian regulatory requirements for personalized including 3D printed medical devices – February 2023
TGA has updated its regulatory framework to address latest developments in personalized, including 3D printed, medical devices
Since the enactment of Australian medical device regulations in 2002, computing technology, material science and imaging technologies have progressed rapidly, making 3D printing technology accessible and affordable. This has in turn enabled large-scale manufacturing of medical devices that are customized to individual patients, including high risk orthopaedic implants. The regulatory requirements for custom-made devices which assumed only low numbers would be produced were no longer suitable.
The February 25th, 2021, changes to Australian regulations included a new regulatory framework for personalized medical devices, including new definitions. Personalized medical devices are defined as devices that are specifically designed and manufactured, or adapted/modified, to meet the needs of an individual. The TGA distinguishes three categories of personalized medical devices:
- Patient-matched medical devices
- Adaptable medical devices
- Custom-made medical devices
Custom-made medical devices retain their definition from before, i.e.:
- They are intended by the manufacturer for a particular patient, or for the sole use of a particular healthcare professional (HCP) in the course of their medical practice; and
- They are manufactured based on a written request of an HCP, and with design characteristics specified by the HCP, to address he anatomical and physiological features of the intended patient, or a pathological condition of the intended patient; and
- There is no kind of medical device included in the Australian Register of Therapeutic Goods (ARTG) to address those needs to an appropriate level.
Example of custom-made device: individually made bone replacement for the sole use of a particular patient, where there is no device (orthopedic implant) included in the ARTG that could be used to reconstruct that bone.
Adaptable medical devices are mass-produced medical devices that are intended by the manufacturer to be assembled or adapted after they have been supplied, in accordance with the manufacturer’s instructions, to:
- address the anatomical and/or physiological features of a particular individual; or
- address a pathological condition of a particular individual; or
- otherwise perform as intended by the manufacturer.
Example of an adaptable medical device: mass-produced polymer surgical implant for cranial reconstruction, supplied sterile, and intended to be formed during the cranial reconstruction procedure to suit the individual patient’s anatomical feature.
Patient-matched medical devices are medical devices that are:
- manufactured by the manufacturer, within a specified design envelope, to match either or both of the anatomical and physiological features of a particular individual; or a pathological condition of a particular individual; and
- designed by the manufacturer (even if the design is developed in consultation with a health professional); and
- manufactured using production processes that are capable of being validated and/or verified, and reproduced.
A ‘design envelope’ is defined as the range between minimum and maximum dimensions, performance limits or other relevant factors that: (a) characterize a medical device for production purposes; and (b) may be based on a standard device template.
Example of a specified design envelope: well-characterized design of patient-matched therapeutic insoles for most types of foot pathologies and most foot sizes.
Under the new framework, almost all of the medical devices that previously met the definition of ‘custom-made’ will now meet the definition of ‘patient-matched’. Only a small number of devices will continue to meet the definition of custom-made.
Patient-matched medical devices must be approved by the TGA and included in the ARTG before being supplied in quantities greater than five (5) per financial year. On the other hand, custom-made devices are not required to be included in the ARTG (as before).
Both custom-made and patient-matched devices are designed and produced for a particular individual. The key difference is that a custom-made device is so rare and unique that there is no way that the manufacturer can adequately validate the design of the device, or adequately validate and/or verify the production process, at the time it is requested.
The new regulatory framework also introduced the concept of Medical Device Production Systems (MDPS). Health professionals and facilities currently using a system to produce patient-matched medical devices meet the definition of ‘Manufacturer’ under Australian regulations, and therefore must meet the relevant obligations for manufacturers. The MDPS concept provides healthcare facilities wanting to produce patient-matched device in-house for treating their patients with the option of including their MDPS in the ARTG.
High risk personalized medical devices that require inclusion in the ARTG are expected to have evidence of clinical evaluation in their technical file, according to TGA’s Guidance Clinical evidence guidelines: Medical devices of June 2022. Where clinical trial data are required to provide the clinical evidence, the clinical trials must be conducted in accordance with the requirements of Australian Clinical Trial Handbook