Increased regulation of 3D-printed medical devices 10 min read
Australia's new regulations governing personalised medical devices, including 3D-printed devices, will have significant effects.
They narrow the definition of custom-made medical devices, which will continue to be given regulatory exemptions but be subject to more regulatory requirements. Two new categories – 'patient-matched' devices and 'adaptable' devices – fall outside this definition and do not benefit from the exemptions. This is likely to mean that a number of 3D-printed medical devices, especially batch-made ones, will now need to be included in the Australian Register of Therapeutic Goods (the ARTG) and be subject to oversight of manufacturing. 3D-printed anatomical models and 3D-'bioprinted' devices that incorporate human cells are also subject to regulation as medical devices.
Healthcare providers that currently use 3D printing to make devices that now fall within these categories need to choose between obtaining certification as manufacturers of medical devices; outsourcing the manufacturing; or reducing their role in the manufacturing, by using an externally supplied 'medical device processing system'.
The regulations came into force in early 2021, having been delayed due to the COVID-19 pandemic. Some of the requirements are subject to a transition period, and the delay does not affect when it will end: makers and users of medical devices that are subject to the transition period still need to be compliant with the new rules by 31 October 2024.
- The new regulations remove existing exemptions from some categories of 3D-printed personalised medical devices, especially batch-made devices, anatomical models and 'bioprinted' devices. This will require manufacturers to register and obtain certification in the same way as for non-personalised medical devices.
- Although other 3D-printed personalised medical devices will retain exemptions, the regulatory requirements for these devices will increase.
- Healthcare providers that currently use 3D printing to make devices that have lost the exemptions need to obtain certification as manufacturers, unless they outsource the manufacturing or use an externally supplied 'medical device processing system'.
Legal, compliance, procurement, outsourcing, regulatory, research and development.
Customised medical devices have a long history: surgeons and dentists have been making casts and prosthetics to fit patients since the time of the Pharaohs. The development of 3D printing and other additive manufacturing technologies is rapidly changing this aspect of healthcare. Because objects can be created with great precision by building successive layers of raw material from a digital design (eg a computer-aided design or a magnetic resonance image), it allows medical devices to be created that match a patient's specific anatomy, or with complex internal structures. Additive manufacturing technology allows medical devices to be modified or customised for each patient quickly, cheaply and efficiently, without the need to physically modify the equipment or tools used to make the devices. 3D-printing systems are versatile and relatively cost effective, allowing on-premises 'printing' by individual healthcare providers. Medical devices that can be customised via 3D printing include surgical guides, prosthetics and cranial implants.
Current regulatory scheme
In Australia, the Therapeutic Goods Administration (TGA), a division of the Department of Health, regulates medicines, medical devices, gene technology and blood products. Before the reforms enacted in 2019, 3D-printed medical devices were regulated as a subset of 'custom-made medical devices'.
'Custom-made medical devices' included all medical devices that are made specifically in accordance with a request by a health professional that specifies its design characteristics or construction, and is intended to be used only in relation to a particular individual or by the health professional to meet special needs arising in the course of practice.
Medical devices are generally subject to a range of regulatory safeguards, including the requirement for a pre-market assessment of its safety and performance, and that the device conforms to the Essential Principles (a set of fundamental design and manufacturing requirements for medical devices). Medical devices also generally must be included in the ARTG. Except for those falling into the lowest risk category, this involves applying for a market authorisation from the TGA. After the device is approved, post-market monitoring and reporting obligations continue to apply.
Unlike most other medical devices, custom-made ones are:
- exempt from inclusion in the ARTG; and
- not subject to third party oversight of manufacturing, or evidence of compliance with the Essential Principles.
However, they are required to be notified to the TGA, and have post-market surveillance and reporting requirements in place.
Path to the current reforms
Concerns have been raised in recent years that this regulatory scheme has not kept pace with developments in technology. The exemptions given to custom-made medical devices are based on the way they have historically been used: generally for low risk products, and they have been small in number. In recent years, however, higher-risk devices, such as implants, have begun to be custom-made, including by 3D printing, and their use has become far more common. As the 3D-printing industry has expanded, the TGA has become concerned that new entrants have limited awareness of applicable regulatory requirements, such as that for a quality management system (QMS).
These concerns fed into the Expert Panel Review of Medicines and Medical Devices Regulation commissioned by the Federal Government. In 2015, this review's report recommended (among other things) the harmonisation of the regulation of medical devices in Australia with that of the European Union, as the best path to internal harmonisation that would reduce unnecessary compliance costs for businesses due to inconsistent regulatory approaches in different jurisdictions.
As part of the implementation of the recommendations, considerable formal engagement and consultation with the medical device industry and key stakeholders were conducted, including targeted workshops in August 2017, and two consultation periods in late 2017 and early 2019. Allens has previously reported on the reforms put forward in the two consultation papers, including considering how to strike the right balance between innovation and protection of 3D-printed medical devices at an expert panel event following the release of the 2017 consultation paper, and in an Insight that considered key new definitions and changes for 3D-printed anatomical models proposed in the 2019 consultation paper. An 'action plan' was adopted in April 2019.
Two formal international consultations were also conducted, to ensure the proposed reforms aligned with the approach adopted by the International Medical Device Regulators Forum (the IMDRF).
The personalised medical device reforms were formally adopted on 12 December 2019, by amending the Therapeutic Goods (Medical Devices) Regulations 2002. This was accompanied by a Regulation Impact Statement published by the TGA, which assessed the various proposed options and the impact of the option ultimately chosen. In November 2020, the TGA also released a publication, Personalised Medical Devices (including 3D-printed devices), which provides guidance on interpreting the new reforms (the TGA Guidelines). These reforms are the first plank of the comprehensive package of regulatory reforms being implemented by the TGA.
A number of aspects of the changes impact on 3D-printed medical devices. The following figure provides an overview of the regulatory amendments to produce a more granular regime by introducing two new definitions and refining the existing definition of 'custom-made medical devices'.
A more granular regime
The new regulations amend the existing definition of custom-made medical device' to considerably reduce its scope, focusing on truly customised medical devices made specifically at a request of a healthcare professional and intended for a specific patient, or use by a specific healthcare professional. Eg a custom-made medical device may include an implant produced by a manufacturer with particular design characteristics specified by a health professional to address the anatomical features of a patient. These devices continue to receive the current exemptions, though with some increase in regulatory requirements (discussed below).
Two new definitions have been created for personalised medical devices that are more likely to be batch- or mass-produced, and therefore seen as higher risk.
- The first, 'patient-matched medical device', is carved out from the existing custom-made category. These are devices matched to an individual's anatomy, physiology or pathological condition within a specified design envelope, and where the manufacturer is responsible for design, and uses production processes that can be validated and/or verified, and reproduced. An example is an implant produced by a manufacturer with a specific design envelope, but customised to ensure the implant fits the particular anatomy of a patient and manufactured using a process that is capable of being validated.
The majority of currently supplied devices that previously fell within 'custom-made medical devices' now meet the definition of a patient-matched device and no longer qualify for the regulatory exemptions available to custom-made devices. They are subject to the same requirements as mass-produced medical devices, such as third party regulatory oversight and inclusion in the ARTG, subject to transition arrangements.
- The second, 'adaptable medical device', did not fall within the existing custom-made category at all. These are mass-produced devices, intended to be assembled or adapted after they are supplied, in accordance with the manufacturer's instructions, to an individual's anatomy, physiology or pathological condition, or otherwise perform as intended by the manufacturer. Eg an adaptable medical device can be a mass-produced surgical implant that is intended to be manipulated during a surgical procedure to conform to a patient’s anatomical features. These devices did not qualify for the exemptions for custom-made devices, and the new rules specific to this category are intended to confirm, not change, existing requirements.
This three-tier structure matches the structure of the IMDRF scheme, as was flagged in the second consultation paper published by the TGA in March 2019, as we reported. However, whereas the proposed definitions in the second consultation paper adopted the IMDRF definitions directly, the final definitions adopted align with, but are worded differently from, the IMDRF definitions.
In addition, some classification rules have been changed to deal with specific types of 3D-printed medical devices.
- The category of medical devices that record diagnostic images has been expanded beyond X-rays. New classification rules apply to anatomical models used for diagnosis or investigation (but not eg education or training). 3D-printed models of patient anatomies used for these purposes (eg for surgical planning) will now fall within this category of medical devices. Software for digital imaging will also be regulated: eg an app that uses photos to generate virtual anatomical 3D models intended to investigate the effectiveness of various treatment options. The rules that currently apply to X-ray film will apply to any technology that falls into this category. This means that manufacturers of 3D-printed anatomical models are required to hold appropriate conformity assessment evidence.
- Medical devices with a human-origin component – such as a 3D-printed implant that incorporates cells from a patient or 'bioprinting' – are now regulated as a 'medical device with a biological component' under the regulatory regime for medical devices, rather than as 'biologicials' regulated through the regime for biologicals. This brings Australia's approach broadly in line with that in major jurisdictions including the EU, the US and Canada.
These devices need to apply for inclusion in the ARTG as medical devices. Conformity assessment certification by the TGA is required, in line with other combination products. As part of this process, the biological components are required to meet all applicable regulatory requirements (including regulations relating to biological materials already applicable under the Therapeutic Goods Act 1989), and a fee is payable during the design-examination process.
Increased regulatory requirements
While custom-made medical devices falling into the new, narrower, definition continue to enjoy regulatory exemptions, regulatory requirements have been stepped up.
The new regulatory requirements are:
- More information needs to be provided to the TGA and patients. In particular, a manufacturer's statement must be provided to the patient, aligning with EU requirements. An annual report must be provided to the TGA.
- The TGA is permitted to inspect manufacturing sites. It envisages exercising this power on the basis of a risk assessment, based on implications for health and safety.
- Documentation about an implantable custom-made medical device will be retained for a minimum of 15 years, again aligning with the EU, instead of the current five years.
Exemptions for 3D printing by healthcare providers
The new regulations also introduce the concept of 'medical device production systems' (MDPS). This provides an exemption for healthcare providers who produce personalised devices for treating their patients, so that they would not be required to hold manufacturing certificates as manufacturers of medical devices.
An MDPS is defined as a collection of the raw materials and main production equipment specifically intended to be used together and by a healthcare provider, or healthcare facility, to produce a specific type of medical device for treating their patients. The system also includes the medical device it is intended to produce. All components of the MDPS must be validated as a production process to consistently produce the intended medical device with the use of the supplied instructions. MDPSs are medical devices and must be included in the ARTG, with classification and assessment requirements based on the devices they are intended to produce. The equipment and consumables used in the MDPS are not considered separate medical devices. The following infographic illustrates the necessary components to make a medical device in an MDPS.
Because the healthcare providers or healthcare facilities that use MDPSs are not regarded as manufacturers, they do not need conformity assessment certification to use the MDPSs. Eg hospital physicians can use an MDPS where it has been developed and assembled using expertise to 3D-print anatomical models for surgical planning without certification as a manufacturer, despite the new requirement for 3D-printed anatomical models to hold conformity assessment evidence. However, if in the future the hospital wanted to supply the system to other healthcare facilities, it would need to include the system as an MDPS in the ARTG.
The new regulations also modify the existing exemption for adaptation of a medical device by a user. Under the current regulation, a person who assembles or adapts a medical device already supplied to personalise it for a patient, is not a manufacturer if the assembly or adaptation does not change the purpose intended for the device. Eg a dentist who makes minor modifications to a dental appliance for optimal fit would come under this exemption. Under the new regulations, for the new category of adaptable medical devices, the user who makes the modification or adaptation to personalise the device is only exempted from regulation as a manufacturer if the modification or adaptation is in accordance with validated instructions provided by the manufacturer, and without affecting compliance of the device with the Essential Principles. This places a more stringent requirement for the same dentist who 3D-prints a dental crown, rather than using traditional dental resin, to fall under the exemption.
The reforms were originally set to be implemented from 25 August 2020. However, as the medical devices industry and healthcare professionals were required to redirect their efforts on the regulatory changes to focus on the COVID-19 crisis, the Government announced a delay to the scheduled implementation timetable. The reforms for personalised medical devices (including 3D-printed devices) were eventually implemented from 25 February 2021.
The reforms include a transition period for certain medical devices, which means some makers and users of 3D-printed medical devices have additional time before they need to be compliant with the new rules. Medical devices with a different classification from that applying under the new regulations and are already included in the ARTG before 25 November 2021, or whose application for such registration was made before 25 November 2021, may rely on the transition period. Additionally, programmed or programmable medical devices, software that is a medical device, and personalised medical devices that are included in the ARTG because of an application made before 25 February 2021 are also subject to the transition period. Patient-matched medical devices continue to be exempt from the requirement to be included in the ARTG (if they were supplied as custom-made medical devices before 25 February 2021) until 1 November 2024. New patient-matched devices that have not been supplied in Australia as custom-made medical devices before 25 February 2021 are not eligible for the transition arrangements.
The delay to the implementation of the reforms did not change the end of the transition period. As such, makers and users of eligible 3D-printed medical devices will still need to be compliant with the new rules by 31 October 2024.
The TGA admits in its regulatory impact statement that the cost impact of the proposed reforms is difficult to estimate. Modelling behaviour based on stakeholder feedback, it estimates an annual impact on businesses of $1.26 million, and an impact on individuals of $5000.
The use of 3D printing by dentists and hospitals will be able to continue. However, hospitals, in particular, are likely to need to expend additional money and effort to have devices that fall into the new patient-matched category listed in the ARTG, and to obtain certification for their manufacturing.
The certification may drive changes in the structure of the supply chain. Eg hospitals may be motivated to outsource the manufacturing of patient-matched devices, or use an externally supplied MDPS (and thus limit their involvement in manufacturing).
The increased burden on healthcare providers will have a flow-on effect on the health insurance sector.
At the other end of the supply chain, regulatory alignment with the IMDRF scheme and with major jurisdictions overseas is likely to benefit 3D-printing service providers and manufacturers of 3D-printing systems that have a cross-border business. Regulatory alignment is also likely to make it easier for Australian service providers and manufacturers, once they are compliant with Australian regulations, to enter the market overseas.
On the other hand, because personalised devices now need to fit within the patient-matched category in order to obtain certification, this will influence decisions by industry participants to design and manufacture such devices, and the decisions by healthcare providers to adopt such devices. It is therefore still to be seen whether the reforms will expand or limit investment in, and use of, personalised medical devices.
- If you are a healthcare provider or facility, review any use of 3D printing in treatment or diagnosis now for any activities affected by the new regulations.
- If you are a supplier of 3D-printed medical devices or services, review your delivery model now for the impact of the new regulations.
- Speak to a member of the Allens Healthcare team for advice in relation to your exposure to the new regulations.