The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of healthcare products, has published an updated guidance document dedicated to personalized medical devices (including 3D-printed devices). The document constitutes a revised version of guidance dedicated to the same matter issued earlier by the TGA and incorporates the recent changes to applicable regulations.
The guidance provides an overview of the new regulatory framework and highlights the most important aspects to be considered. It is important to mention that due to its legal nature, the document is not intended to introduce new rules itself, and its provisions are non-binding. In case of any discrepancies with the provisions of applicable legislation, the latter should prevail.
First, the TGA clarifies that personalized medical devices, in general, could be divided into two main categories:
- Those usually used in the course of ordinary clinical practice but requiring certain alignment with specific needs; and
- Those that are manufactured to meet the needs of a specific patient while not being manufactured on a regular basis.
From the regulatory standpoint, the approach to be applied to these categories should be different. Medical devices manufactured on a regular basis could be aligned with the appropriate requirements applicable for all devices of the same type, while devices created to meet the needs of a specific patient require a different approach. Current legislation addresses both categories of personalized devices and provides the requirements to be applied in each case.
The present guidance is intended to provide medical device manufacturers and other parties involved with additional clarifications regarding the current framework and assist in interpreting the provisions of respective legislation.
Adaptable Medical Devices
According to the current legislation, an adaptable medical device means a mass-produced medical device that is intended by the manufacturer to be assembled or adopted after it has been supplied, in accordance with the manufacturer’s instructions, to:
- Address either or both of the anatomical and physiological features of a particular individual; or
- Address a pathological condition of a particular individual; or
- Otherwise perform as intended by the manufacturer.
At the same time, the TGA emphasizes that the rules and requirements adaptable medical devices should meet remain intact – it is only a definition added to improve legal clarity. These devices should still be included in the ARTG in accordance with the applicable risk-based classification.
As prescribed by Essential Principles, adaptable medical devices should be accompanied by instructions describing how they should be aligned with specific needs.
Custom-Made Medical Devices
The category that incurred the most changes is custom-made medical devices – those initially manufactured to meet the needs of a particular patient on the basis of the appropriate request submitted by a healthcare professional. Such a request should contain information about the particular case sufficient for the manufacturer to produce a device that will fit the intended recipient. This approach is usually applied in cases when there is no medical device already placed on the market and manufactured on a regular basis that will meet the needs of a particular patient. The authority additionally emphasizes that this category of devices does not include patient-matched medical devices, adaptable medical devices, or other mass-produced medical devices. Custom-made medical devices are also exempted from inclusion in the ARTG, which, in general, is mandatory for all medical devices. However, they are still subject to oversight by the TGA, and the manufacturers of such products should still comply with any and all applicable requirements set forth under the medical devices’ framework.
In summary, the present TGA guidance describes the most important changes to the regulatory approach for personalized medical devices. The document provides additional clarifications regarding each type of personalized medical device and highlights the key aspects to be considered by medical device manufacturers with regard to compliance with the applicable requirements depending on the regulatory status of the device in question.
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