The rise of 3D printing technology in medicine and healthcare is challenging existing regulatory frameworks as higher risk 3D printed medical devices are developed. Tracy Lu, senior associate for Allens in Sydney, explains that Australia is at the forefront of dealing with this regulatory reassessment.

The definition of a custom-made device – under the Therapeutic Goods Regulations – is currently sufficiently broad to capture a range of medical devices, from those that are adapted from a standard template to suit a patient’s anatomy to devices which are truly one-off.

Custom-made devices are currently subject to limited conformity assessment procedures and are exempt from premarket assessment, although they are not exempt from post-market monitoring.

The existing regulatory regime for custom-made devices was developed when the risk associated with such devices was low. With the advent of medical 3D printing technology, however, more and more higher risk devices (which would otherwise attract higher risk classifications and stringent premarket oversight) are being released to the market.

In response to this change in environment, the TGA has put forward five proposals in a recent consultation paper.

First, a new umbrella term “personalised medical devices” is proposed, which will include the subcategories “custom made”, “customised” and “patient-specific”. Custom made devices would be limited to those intended for the sole use of a particular patient and for which there is no commercially available alternative. This definition also excludes mass produced devices adapted to suit specific requirements of any professional user and patient-specific devices.

Customised devices would refer to devices supplied by a manufacturer with a specific intended purpose that must be adapted or assembled, in accordance with the manufacturer’s validated instructions, to suit an individual patient. Patient-specific devices would refer to devices based on a standard template model that is matched to a patient’s anatomy, or by using the full anatomic features from patient imaging.

At a recent 3D printing in Medicine and Healthcare industry event hosted by Allens, a representative of the TGA noted that the changes to the definitions are the most significant changes in this consultation paper. A new vocabulary would allow all the relevant stakeholders to have meaningful conversations regarding 3D printing in the context of medical device regulations.

Second, given the proposed changes to custom-made devices, the more limited conformity assessment procedures would now apply to a narrower subset of devices and the TGA would also have the power to enter and inspect manufacturing sites. Next, for customised devices, the TGA proposes that a manufacturer’s liability would be limited only to adaptations which are carried out in accordance with the manufacturer’s validated instructions. Further, the TGA recognises that some healthcare providers may have in-house 3D printing capability which allows them to produce devices which would fall under the current definition of custom made devices and the new proposed definition of patient-specific devices. This means that the exemptions for custom made devices would no longer apply. Therefore, where the patient-specific device is of a lower risk classification, TGA proposes to exempt such providers from regulation as a manufacturer.

Fourth, devices that are intended by the manufacturer to be used to record diagnostic images (for example 3D scanners) would have the same classification as X-rays. And finally, medical devices incorporating materials of human origin would be regulated as medical devices rather than biologicals (for which different regulatory requirements apply), so that there is consistency of approach across medical devices.

It is positive to see the Australian regulator take a proactive role in addressing the regulatory challenges posed by medical 3D printing. TGA in fact chairs the issue of personalised medical devices for the International Medical Device Regulators Forum, which aims to harmonise regulatory approaches across a number of jurisdictions. The TGA’s recent proposals, however, do not cover technical considerations for designing, manufacturing and testing such devices – it is also important to develop adequate quality controls over those aspects to ensure the safety and wellbeing of patients.