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Regulation impact statement: Proposed regulatory scheme for personalised medical devices, including 3D-printed devices
Version 1.0, December 2019 - OBPR reference: 24680
Option 2 - Changes to better regulate personalised medical devices
The proposed changes to the regulatory framework under this option aligns with the approach of other regulators and the recommendations of the IMDRF working group for personalised medical devices. The proposed regulatory controls, based on the internationally harmonised approach, involves the introduction of three categories (custom made, patient matched, and adaptable) of personalised medical device, with associated regulatory controls applied commensurate with the risks and nature of the three categories. The risk of harm to patients would be minimised, and healthcare providers would have greater assurance that the medical devices they use would perform as intended.
The introduction of the medical device production system (MDPS) would ensure ongoing safety of the production of medical devices, usually at the point of care, by healthcare professionals who would otherwise be required to obtain manufacturer certification. The introduction of this new approach would provide improved outcomes from systems that are currently not regulated in Australia, together with reducing the regulatory burden on those healthcare professionals who would otherwise be considered to be manufacturers under the Act. It would also align Australia with the internationally recognised best-practice (IMDRF) model for such systems.
The updates to the classification rules relating to anatomical models would result in the application of appropriate regulatory oversight of manufacturers who make models for the investigation of the anatomy and for the planning of surgeries. The new rules would ensure that the regulatory framework is updated so that oversight of new digital technologies is in line with the equivalent analogue technologies of the past (i.e., X-ray film).
The changes relating to the way medical devices with human-origin components are regulated would mean that the framework would be aligned with international norms, and would ensure that the human-origin components of combination medical device products are subject to appropriate regulatory scrutiny in the same way that other combination products are subject (such as medical devices with animal-origin material).
The new definition of 'adaptable medical device' and additional information on the boundaries associated with the adaption of medical devices will improve clarity for the sector, and highlight the impact on the safety and performance of the device when adapting medical devices outside of the manufacturer's instructions.
There are additional benefits relating to Option 2 as follows:
- a levelling of the playing field for manufacturers which will narrow the scope of devices captured by custom-made definition, and ensure comparable patient matched and mass produced medical devices are regulated in a comparable way;
- improving TGA's visibility of the custom-made medical devices industry in Australia, so the size and scope of the sector can be monitored and any trends or emerging issues for individual devices or personalised medical devices more broadly, and addressed;
- opening up international markets to domestic manufacturers (who would be required to meet internationally harmonised requirements);
- facilitating sponsor access to reimbursement pathways (such as the inclusion of patient-matched medical devices on the Prostheses List, as discussed above);
- improving public confidence in the regulatory framework that applies to personalised medical devices;
- ensuring that patients are better informed about the custom-made medical devices they have been provided with; and
- improved post market monitoring and compliance and enforcement mechanisms.
Option 2 is a comprehensive package of interrelated reforms that provides for an alignment of the requirements for personalised medical devices with the objectives for regulating medical devices in general, namely the:
- minimisation of public health and safety risks;
- maintenance of consumer confidence in the safety and performance of medical devices;
- alignment, as far as possible, with international best practice; and
- minimisation of unnecessary regulatory burden.