Options

On this page: Criteria for assessment options | Options considered | Option 1 - Status Quo | Option 2 - Comprehensive package of regulatory reforms | Option 3 - Regulate custom-made medical devices in line with other medical devices

Criteria for assessment options

Some of the criteria used in assessing the various options included:

• the degree by which the option would likely address the three dimensions of the identified problem
• the overall regulatory burden (for example, a delayed implementation of an exemption would introduce unintended regulatory burden on the exempted group)
• equitable and proportionate regulation of 'main stream' and personalised medical devices to safeguard the health and wellbeing of the Australian public, while also providing access to emerging technologies and increased equivalence of regulatory burden on the device manufacturers and sponsors
• the potential for partial implementation to introduce unintended loopholes and gaps (which could possibly then be exploited)
• the additional benefits to be attained through early implementation of globally harmonised regulations
• the ability to address the recommendations in the Medicines and Medical Devices Review (specifically Recommendation 20, harmonisation with the EU)
• the TGA's capacity to effectively absorb any changes and still provide agreed service levels
• the complexity for stakeholders and the TGA in implementing these changes in a piecemeal fashion and timeframe

Options considered

A number of approaches and options for addressing the problem were considered, based on consultation over several years.

Three key options explored in this RIS

The three options explored in detail in this RIS are:

Option 1 - Maintain the status quo (no change)

Option 2 - Introducing a comprehensive package of regulatory reforms

Option 3 - Regulate custom-made medical devices in line with other medical devices

Alternative approaches also considered

In addition to the three options listed above, a number of alternative approaches were also considered but then discounted. They included: an exploration and preliminary analysis of alternative tools as education campaigns; introduction of voluntary codes of conduct; and alternative regulatory framework mechanisms (that is, beyond the current Act, such as Consumer Law). However, it became apparent that these alternatives not be able to address the limitations with the current regulatory framework. None of them adequately deals with the problem - the current uniform exemption of all devices falling within the terms of 'custom-made medical device' from both regulatory requirements and oversight applicable to devices with the same 'risk profile'. Education campaigns will not require reporting to the TGA of the devices supplied by the manufacturer or sponsor, it will not allow inspection of premises at which the devices are made and would do nothing to ensure that each patient is assured of receipt of information about that device.

In the face of an existing robust regulation framework for medical devices which can easily be adapted to appropriately regulate personalised medical devices without unnecessarily increasing regulatory burden there is no compelling reason to allow for a voluntary code of conduct to apply to a subsection only of medical devices. Precisely who would promote such a conduct and settle on its terms is unclear.

Option 1 - Status Quo

Under the status quo, as previously described, personalised medical devices are captured by the definition of custom-made medical device. This means that subsets of the custom-made category, i.e., those which are more like standard commercial devices than bespoke custom-made devices, are not regulated in the same way as commercial devices supplied in differing sizes. All custom-made devices, regardless of potential to cause harm to a patient, are exempt from the requirement to undergo third-party scrutiny of their associated evidence of safety and performance; and their manufacturers cannot be inspected by the TGA under the powers of the existing Act and associated regulations. The TGA would continue to have limited visibility of custom-made manufacturing and supply in Australia based on the current notification requirement under the existing regulations, with a limited ability to undertake compliance enforcement actions against unsafe devices.

In addition, there is no mechanism, under this option, to recognise the emerging point-of-care manufacturing systems that are being marketed to healthcare providers, and that are intended to allow healthcare providers to produce medical devices for treating their patients.

New methods for using personalised anatomical models for investigating the anatomy and planning surgeries would not be required to undergo third-party scrutiny, in contrast to the requirement applied to now out-of-date analogue methods for achieving the same aim, such as X-ray film.

Medical devices that include a human-origin material component, but that have a primary physical or mechanical function as a medical device, would still be required to be regulated under the Australian biologicals framework instead of the medical devices framework. The medical devices framework already allows medical devices to have medicine components or animal-origin components, which are assessed by the relevant areas of the TGA, while the business process for certification follows the medical device pathway. This would not be expanded to allow the same consideration for medical devices that include human-origin material as is the case in other jurisdictions. Australia would remain out-of-step with other comparable international regulatory frameworks.

Ultimately, under the status quo, patients will continue to face an unmitigated potential for harm from an increasing number of medical devices that have insufficient regulatory oversight.

Impacts under Option 1

Under this option, industry and certain healthcare providers using personalised medical devices, including those using 3D-printed medical devices, would continue to operate as they currently do. Given the trajectory of technological development, the number of devices falling within the existing regulatory framework for custom-made medical device would expand rapidly over the next decade and beyond.

The current regulation would continue to apply, and appropriate regulations would not be available to provide regulatory oversight to custom-made devices and other personalised medical devices produced through new technology. Additionally, responsibilities of persons who choose to use medical devices in an off-label manner would remain unclear.

Under Option 1, there is no immediate change in direct compliance costs for industry. Over time, as some medical devices shift into the custom-made medical device space, administrative costs for those sponsors and manufacturers in respect of those products would drop, as third-party conformity assessment and inclusion on the ARTG would no longer be required (detailed in costs below). As the sponsors and manufacturers of custom-made medical devices would still be required to largely conform to the essential principles, their internal design, production, and oversight procedures should not diminish (although they would change as they shift to personalised versions of the medical devices being produced).

Unlike for devices included on the ARTG, there would be no independent assessment of this continued compliance with the essential principles. This may result in safety concerns emerging for some patients, as the existing risk-management strategy for custom-made medical devices (clinical judgement and oversight by the prescribing health professional) is likely to become less effective as custom-made medical devices of higher risk and increasingly greater technical complexity enter the market.

Costs and potential flow on effects

Administrative savings to industry

The rapid expansion in the use of personalised medical devices is expected to change the balance in mass produced and custom-made medical devices over time.

It is not possible to accurately estimate the number of custom-made medical devices which might emerge over coming years, or to know which of these would replace medical devices which are currently or would in the future be included in the ARTG.

Where a custom-made medical device would otherwise have been developed, a mainstream medical device would need to be included in the ARTG; under this option, the costs associated with regulatory compliance (seeking third-party certification of conformity assessment procedures, applying for inclusion in the ARTG, and maintaining that entry over time) would be saved.

On average, each ARTG entry not required (shifting product lines from mainstream to custom-made) would save industry administrative effort costing around:

• $52,000 for conformity assessment application and assessment
  • This would apply to around eight percent of ARTG entries, where they seek TGA conformity assessment certification (the remainder reuse overseas certification to support their Australian application, which is not a cost incurred for Australian regulatory requirements)
• $4,500 for each ARTG entry application and assessment, and a further $1,000 to $1,600 if the application is subject to audit (mandatory for high-class medical devices relying on overseas certification)
• $2,400 per annum in ongoing compliance costs for ARTG entries, and a further $6,200 to maintain TGA conformity assessment certification.

These costs are based on the time required to comply with application requirements (completing application forms, gather the evidence to support applications, etc.) and complying with ongoing requirements (such as adverse event reporting, annual reporting, maintaining required records, etc. for ARTG entries, and annual surveillance of manufacturers holding TGA conformity assessment).

While there is no way to estimate how many devices might shift from mainstream medical devices to custom-made medical devices over the coming years should the status quo be maintained. However, the administrative cost of maintaining each ARTG entry and the related conformity assessment certification is significant.

These figures cover the average time by manufacturers and sponsors to establish and maintain their ARTG entry, and do not include the regulatory fees and charges they would also incur (which are not included in Regulatory Burden Estimate).

As outlined above, in addition to the incentives to develop personalised medical devices in terms of patient outcomes and market share, there are significant cost incentives for such devices to be regulated as custom-made, to decrease regulatory oversight and associated costs.

Option 2 - Comprehensive package of regulatory reforms

Option 2 involves introducing a comprehensive package of reforms to the Australian medical device regulatory framework to address the three dimensions of the problem outlined above, whilst endeavouring to balance the benefits, risks, and regulatory burden. The proposed elements of the reform package are summarised in Figure 2 below.

The changes, supported by a change management plan including education on the changes to affected industry, comprise the following six elements:

1. Introduction of new definitions for personalised medical devices;
2. A change to the requirements for supplying custom-made medical devices in Australia, so that additional information must be provided to the TGA and to patients and, to allow the TGA to inspect manufacturing sites;
3. Introduction of a framework for regulating a medical device production system that would allow healthcare providers to produce personalised devices for treating their patients, without the need for manufacturing certification;
4. An update to the classification rule for medical devices that record diagnostic images so that it includes any device for this purpose and not just X-rays, for example, 3D-printed models of patient anatomy;
5. A change to the regulation of medical devices with a human-origin component such that they are regulated as medical devices with a biological component rather than as pure biologicals (for example, a 3D-printed implant incorporating cells from a patient); and
6. Clarification that any modifications or adaptations to personalise a medical device that has already been supplied must have been intended by the original manufacturer of the device.

These changes have been consulted publically with relevant stakeholders over a twenty four month period through various mechanisms^[25] and have received strong stakeholder support. In addition, they represent harmonisation with global best practice.

Details of proposed changes

In this section: A. New definitions for personalised medical devices | B. Additional requirements for custom-made medical devices | C. Production systems for healthcare professionals | D. New classification rules for diagnostic imaging and anatomical models | E. Regulation of medical devices with human-origin components as medical devices rather than as biologicals | F. Ensure that adaptions and modifications to medical devices are done so safely

A. New definitions for personalised medical devices

What would change?

This change would involve adopting new definitions for personalised medical devices (custom-made, patient matched, and adaptable), aligned with those of the IMDRF.

What would this mean?

Adopting new definitions, aligned with the IMDRF definitions, would result in personalised medical devices being grouped into three categories:

• custom-made medical devices
• patient-matched medical devices
• adaptable medical devices

Custom-made medical device:

The revised definition to be included in the MD Regulations (aligned to the IMDRF definition^[26] is more detailed than the existing custom-made definition:

Medical devices that fit the custom-made definition would still be eligible for exemption from being included on the ARTG (and associated third party assessment, fees and charges), and there would remain limited regulatory oversight applied to their manufacture as compared with non-exempt medical devices. However, the scale and scope of the devices that meet the new definition would be considerably reduced as compared to the current definition of 'custom made' - primarily as patient-matched medical devices will no longer fall within the scope of the custom-made exemption (more detail below).

The new custom-made definition would make it much clearer that the responsibility for the device lies more strongly with the healthcare professional than is the case with the current definition, and the package of reforms additionally includes the introduction of new requirements on manufacturers and sponsors of custom-made medical devices (detailed in Element B below).

Retaining the current exemption from inclusion on the ARTG is important for ensuring that individuals retain the option of accessing truly bespoke devices that would not otherwise be available. This approach balances access to these devices against the risks of reduced regulatory oversight by:

• reducing the scope of the custom-made medical device definition;
• re-balancing the responsibility closer to the healthcare professional (who is best placed to understand the specifics of the individual's case); and
• increasing the requirements (outlined in element B below) place on manufacturers and sponsors of custom-made medical devices making use of the exemption pathway.

Patient-matched medical device:

A new definition of 'patient-matched medical device' (aligned with the IMDRF definition^[27]) would be included in the MD Regulations:

The patient-matched category of devices, which currently falls under the custom-made definition in Australia, would no longer be eligible for this exemption^[28], and instead would require third-party regulatory oversight according to the device risk classification.

Manufacturers of medical devices that meet the new definition for patient-matched medical devices would be required to apply standard conformity assessment procedures (not the special procedure for custom-made devices) according to the classification of their medical devices. This means that for devices that are classified above Class I, conformity assessment evidence from a recognised third-party (such as the TGA or a notified body) would be required. The manufacturer would be required to apply for this evidence and, once received, maintain its currency through complying with post-market requirements such as annual inspections by the issuing agency. These requirements are the same as those for mass-produced medical devices.

Australian manufacturers of, or sponsors importing, patient-matched medical devices would also be required to include their medical devices in the ARTG and to comply with the requirements for maintaining the inclusion, including compliance with the essential principles.

Adaptable medical devices

The regulation of adaptable medical devices would not change. A new definition of adaptable medical device (aligned with the IMDRF definition^[29] )would be included in the MD Regulations:

An adaptable medical device is, by definition, a subset of a mass-produced medical device (albeit one that the manufacturer has designed and produced to be modified after supply) and is not eligible for exemption from inclusion on the ARTG.

Manufacturers of medical devices that meet the new definition for adaptable medical devices already apply the standard conformity assessment procedures (not the special procedure for custom-made medical devices) according to the classification of their medical devices because these types of devices are not eligible for the current custom-made device exemption. This means that for devices that are classified above Class I, they already hold appropriate conformity assessment evidence.

The new requirements would specify that manufacturers of adaptable medical devices should supply validated instructions for their devices to be adapted, assembled or adjusted to suit a particular individual. This should already be the case and so the new requirements would be an express confirmation of the existing arrangements.

Australian manufacturers of, or sponsors importing, adaptable medical devices would also be required to include their medical devices in the ARTG and to comply with the requirements for maintaining the inclusion. Again, this should already be the case. Accordingly, the requirements should not represent a change for this group of stakeholders. There are already many examples of adaptable medical devices included in the ARTG.

Appendix 2 - Regulatory Burden Costings provides further assessment of this change element from page 16 (Change 1).

B. Additional requirements for custom-made medical devices

What would change?

This element would involve changing the requirements for supplying custom-made medical devices in Australia, so that additional information must be provided to the TGA and to patients and, to allow the TGA to inspect manufacturing sites.

The proposed changes would require that:

• the manufacturer's statement about a custom-made medical device is provided to the patient receiving the device;
• the TGA be allowed to enter and inspect custom-made medical device manufacturing sites, in accordance with the authority it has to inspect all other medical device manufacturers;
• a manufacturer in Australia, or a sponsor of an overseas-manufactured custom-made medical device, provides an annual report to the TGA of the custom-made devices it has supplied; and
• documentation about an implantable custom-made medical device is retained for a minimum period of fifteen (15) years.

Note: It is envisioned that such inspections would not be routinely held but would be risk-based according to the implications for health and safety.

These additional requirements for custom-made medical devices aim to address current issues with oversight of these devices:

• Notification of supply: Current custom-made medical device regulations only require a manufacturer in Australia, or a sponsor of a manufacturer overseas, to notify the TGA of the specific kind of custom-made device they are supplying. This is a one-time notification for the category of the device, not an individual notification every time one is supplied.
• Information for patients: A written statement about the device, including whether or not it complies with the essential principles, must also be prepared and kept. The information is not provided to the patient, unlike in the EU, where the manufacturer or authorised representative must also provide this information to the patient.
• Entry and inspection powers: There is currently no requirement for any third-party assessment of custom-made devices or of their manufacture in Australia. The TGA may request information about the devices; however, the legislation does not provide the TGA with the power to enter and inspect manufacturing sites for custom-made devices.
• Record keeping: The manufacturer is only required to keep documentation about a custom-made device for five (5) years after supplying the device. The TGA considers this to be an inadequate period of time for an implantable device due to its long expected lifetime. Problems with implantable devices may not surface until after they have been implanted for more than five (5) years. It is important to have access to manufacturing records when something goes wrong with a medical device in order to investigate potential causes of the problem, which will inform decisions about how to manage the patient. Other jurisdictions, such as the EU, require the documentation to be kept for a period of fifteen (15) years.

These changes would give more transparency to patients receiving custom-made medical devices. Making the manufacturer's statement about the device available to a patient would assist with ensuring that the patient understands the custom-made nature of the device and may also improve the informed consent process. The other changes would provide the TGA with more information about the manufacture and supply of custom-made medical devices in Australia, thereby improving its ability to monitor the quality, safety and performance of these devices.

Appendix 2 - Regulatory Burden Costings provides further assessment of this change element from page 16 (Change 2).

C. Production systems for healthcare professionals

This element would involve introducing a framework for regulating medical device production systems that would allow healthcare providers to produce personalised medical devices for treating their patients without the need for them to hold manufacturing certification.

A medical device production system (MDPS) is 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 his, her or its patients. An MDPS includes the medical device it is intended to produce.

The MDPS may require the use of ancillary equipment or other specified input, however, all components must be validated as a production process to consistently produce the intended medical device with the use of the supplied instructions.

What would change?

MDPSs, like other systems, would be considered to be medical devices and would need to be included in the ARTG. They would be classified and assessed according to the device they are intended to produce. The production equipment and consumable raw materials used in an MDPS would not be considered to be medical devices on their own, unless they fit the definition of a medical device in their own right.

What would this mean?

Healthcare providers or healthcare facilities that use MDPSs to produce medical devices for treating their patients would not be manufacturers under the regulatory framework in relation to those systems. This means that healthcare providers would not need conformity assessment certification for manufacturing medical devices when they make use of an MDPS.

Appendix 2 - Regulatory Burden Costings provides further assessment of this change element from page 30 (Change 3).

D. New classification rules for diagnostic imaging and anatomical models

The key diagnostic technology that was in place when the medical devices regulatory framework was first introduced was the X-ray. At the time the framework was introduced the following specific classification rule^[30] for X-ray film was included to address the potential harm that could result from inaccurate diagnostic X-ray images:

Recent advances in technology in both digital (virtual) imagery (both 2D and 3D) as well as in advanced manufacturing (such as in 3D printing) have led to new methods of providing information to healthcare professionals for use in diagnosis and for the investigation of anatomy for the purpose of planning surgeries.

The accuracy of images and anatomical models then becomes very important in ensuring correct diagnoses and for the safe planning of surgeries. For instance, an anatomical model that misrepresented the location of a nerve to a surgeon could result in significant harm to a patient were that nerve inadvertently severed during surgery, which could be due to an inaccuracy in the anatomical model.

This change would involve:

• updating the current classification rule for medical devices that record non-visible light diagnostic images so that it includes any device for this purpose and not just X-rays.
• introducing new classification rules for anatomical models used for diagnosis or investigation (for example, for surgical planning)

What would change?

TGA is proposing that the same degree of regulatory oversight as that currently applied to X-ray film be applied to the newer technologies that are used to represent the equivalent information today - namely, software that records patient diagnostic images (in the non-visible spectrum), and virtual and physical anatomical models used for diagnostic or investigative purposes. The software used to generate the virtual models would also be the same class.

There have been significant increases in medical devices (both patient-matched and mass produced) relying on diagnostic imaging. Anatomical models for surgical planning have also increased, in support of increasingly ambitious surgical procedures. Consequently, newer methods of diagnostic imaging and the increase in use of anatomical models, are of critical importance.

What would this mean?

Manufacturers of anatomical models would be required to hold appropriate conformity assessment evidence for a Class IIa device. This requirement would apply only to manufacturers whose models are intended to be used for diagnosis or investigation of the anatomy. It would not apply to manufacturers of models that are intended purely for training or education purposes, as these are not considered to be medical devices. The requirement would not apply to hospitals or healthcare practitioners if they used a medical device production system (under element C) to produce the anatomical models for treating their patients, and the medical device production system was included in the ARTG.

Manufacturers of software that is intended to be used to record patient imaging for diagnosis or investigation of the anatomy would be required to hold appropriate conformity assessment evidence for a Class IIa device.

Appendix 2 - Regulatory Burden Costings provides further assessment of this change element from page 42 (Change 4).

E. Regulation of medical devices with human-origin components as medical devices rather than as biologicals

This change would involve medical devices with a human-origin component, for example, a 3D-printed implant incorporating cells from the patient, being regulated as medical devices with a biological component rather than as pure biologicals. This change is included in this package to clarify arrangements and ensure such devices are regulated consistently. These medical devices may be patient-matched or more mainstream medical devices, and may be 3D printed or not.

3D 'bioprinting,' or printing of patient-specific implants that incorporate human-origin material, is increasing. Some jurisdictions, including Canada, the EU and the USA, regulate medical devices with human-origin material as medical devices. In contrast, the Act specifies that any product that comprises, contains, or that is derived from human cells or human tissues is a biological and is thus regulated through the biologicals framework.

This arrangement is not ideal for 3D-printed implantable scaffolds with human materials, as they are analogous, from a design, engineering, production, and assessment perspective, to current implantable scaffolds with incorporated medicine, or animal-origin material, both of which are regulated as medical devices under the Act. The current regulatory arrangements in Australia means they are likely to be subject to different regulatory pathways in other jurisdictions. This can be confusing and costly for manufacturers facing different requirements on their regulatory submissions, for different regulators.

What would change?

Medical devices that contain as a component, but that are not wholly comprised of, human-origin material would not be regulated as biologicals; rather, they would be classified as Class III medical devices with a biological component. This change would mean that a medical device incorporating materials of human origin would be regulated as a medical device and not as a biological, more closely aligning the Australian framework with those of other jurisdictions.

This change would allow for the possibility of abridged assessment of the device components in accordance with current procedures. It is proposed that this change would apply to both viable and non-viable human-origin components because the TGA has the in-house expertise to evaluate both as a component of a medical device.

What would this mean?

Conformity assessment certification by the TGA would be required for medical devices that contain a biological (human origin) component, in line with the requirements for other combination products, including medical devices that contain medicinal, recombinant DNA, microbial, or animal-origin materials. Accordingly, the biological component would be required to meet all applicable regulatory requirements and a fee for the assessment of the biological component during the design-examination process would be applied.

Manufacturers would also need to comply with relevant regulatory requirements for the biological components of their devices relating to biological materials, such as therapeutic goods orders for controlling infectious-disease transmission. Note that manufacturers are already required to meet these requirements under the current biologicals framework.

At this stage, approximately 30 ARTG entries exist for biologicals with human-origin materials, none of which include a medical device component (so no changes will be needed for existing human-origin therapeutic goods). Following this change any medical devices with human-origin material would need to seek inclusion in the ARTG as medical devices.

Appendix 2 - Regulatory Burden Costings provides further assessment of this change element from page 45 (Change 5).

F. Ensure that adaptions and modifications to medical devices are done so safely

This change clarifies requirements for the newly defined 'adaptable medical device', making it clear that any modifications or adaptations to personalise a medical device that has already been supplied must have been intended by the original manufacturer of the device.

Under the current definition of manufacturer in section 41BG(2) of the Act, a person is not considered the manufacturer of a medical device if:

• the person assembles or adapts the device for an individual patient
• the device has already been supplied by another person, and,
• the assembly or adaptation does not change the purpose intended for the device

An example where this exclusion is currently applied is in dental resins for treating patients in the repair of teeth, where the resin material is included in the ARTG. The TGA considers that the dentist will, in accordance with the manufacturer's intention and instructions for mixing, forming, curing, etc. the resin, assemble and/or adapt the resin material for an individual patient. In this scenario, the dentist does not require conformity assessment certification for manufacturing a dental restoration. The regulatory obligations apply to the manufacturer and the sponsor of the resin material.

The assurance that the final assembled or adapted device will perform as intended comes from the validated instructions provided by the original manufacturer. This means that the manufacturer will have tested the performance of samples of its device, when adapted or assembled according to its instructions. In the dental resin example, the original manufacturer makes certain specifications for the use of its product, such as the mixing constituents, the mixing ratio, the type and size of defect to which the resin should be applied, and how long it needs to cure.

When the dentist follows these instructions, it is expected that the dental restoration will perform as intended by the manufacturer of the resin. A person who does not follow the original manufacturer's instructions will be considered a manufacturer and would assume all of the responsibilities of a manufacturer. This includes applying the appropriate conformity assessment procedure and meeting the appropriate compliance and enforcement regime. Regulations for noncompliance with the manufacturer's obligations will also apply because any modifications or adaptations outside of what has been specified by the original manufacturer may affect the device's compliance with the essential principles and might add risk to the health and safety of a patient.

Clarifying this issue in the context of 3D-printed devices is important because healthcare providers now have the option of 3D-printing medical devices, such as dental crowns. It is not considered appropriate that the same approach that is currently being applied to dental-resin material in the ARTG ought to be applied to raw materials for 3D printing, in that, we do not believe regulating the raw material for a 3D-printer is sufficient in ensuring that the final device will comply with the essential principles. This is because 3D-printing involves more than assembling or adapting a device for a particular patient. It is a complex multifactorial process that has an impact on the finished device's compliance with the essential principles. Moreover, a 3D-printing raw material, as with any other manufacturing raw material, is not a medical device, as it is not directly used for treating or diagnosing a patient. Some additional clarification around these issues is therefore required.

What would change?

Additional text would be added to the Act and/or MD Regulations to make clear that a person would not be considered a manufacturer where a medical device has been assembled or adapted for an individual patient and the assembly or adaptation is in accordance with validated instructions provided by the manufacturer of the relevant device. However, if an individual modifies or adapts a device which has already been placed on the market or put into service in such a way that compliance with the essential principles may be affected, that person shall be considered to be a manufacturer and shall assume the obligations incumbent on manufacturers. The person would be subject to the compliance and enforcement regime on that basis.

The need for the provision of validated instructions by the original manufacturer would also be reinforced.

What would this mean?

The effect of these changes would be to clarify the circumstances in which an entity holds responsibilities as a medical device manufacturer. It will also highlight the fact that changes made to a medical device, that are not intended by its original manufacturer, may impact the safety and performance of the device.

Appendix 2 - Regulatory Burden Costings provides further assessment of this change element from page 46 (Change 6).

Impacts of the proposed reforms under Option 2

Modelling and quantification of the regulatory impact of the proposed changes to the regulation of personalised medical devices is presented in Appendix 2, TGA Regulatory Burden Costings - Personalised Medical Devices.

The average annual costs, resulting from the analysis of the impact of the proposed changes, are difficult to estimate for a number of reasons. These costs are primarily driven by the effort associated with hospitals in the private sector seeking certification for manufacturing activities and including their patient-matched medical devices in the ARTG. Hospitals have traditionally manufactured custom-made medical devices and the proposed reforms do not change this activity; that is, this can continue without the need for manufacturing certification under the proposed reforms. However, certification will be required under the proposed reforms if hospitals intend to undertake manufacture of the new proposed category of patient-matched medical devices.

The concept of a patient-matched medical device has recently emerged and, therefore, there is no empirical data on which to base any assumptions regarding sponsor/manufacturer behaviour in this area. That is to say, it is difficult to predict whether hospitals would seek certification for manufacturing patient-matched devices, or whether they would choose to purchase commercially produced patient-matched devices, or whether they would choose to limit their own production of patient-matched medical devices to those made with a regulated Medical Device Production System (the latter two options negating the need for certification).

Given that hospitals would have three options for proceeding with the use of patient-matched medical devices in their facilities, it is likely that only a percentage of hospitals who currently undertake manufacturing activities for custom-made devices would seek certification. The TGA sought comment from representatives from the private hospital sector on their strategies for patient-matched medical devices. While acknowledging that their strategies were still developing, the private hospital sector provided feedback to inform the regulatory burden estimate. Based on this, the regulatory burden of hospitals in the private sector seeking certification was modelled on 33% and 10% of the population with 1, 3, and 5 ARTG entries per hospital. The median result was then used. The outcome is reflected in the following Regulatory Burden Estimate Table.

Regulatory Burden Estimate Table

Average annual regulatory costs (from business as usual)

Change in costs ($ million)	Business	Community organisations	Individuals	Total change in costs
Total, by sector	$1.261	$	$0.005	$1.266

These costing are summarised in more detail in Tables 12 and 13 (p 48 to 49) at Appendix 2 - Regulatory Burden Costings. Note that the public sector is specifically excluded from the Regulatory Burden Framework. This includes the exclusion of TGA fees and charges from these costings.

Potential flow-on effects

As this is a globally emerging area in healthcare, at this early stage it is difficult to define or quantify the potential flow-on effects of implementation. While it is possible to identify what they might be, these are hypotheses only, and it is difficult to obtain or identify any supporting evidence.

The TGA has engaged with a number of stakeholders in order to try to analyse and assess potential flow-on effects across the broader health sector and community, including the potential for increased demand for medical devices and associated services. The potential areas considered were:

• increased pressure on point of care facilities, including hospitals;
• increased pressure on the health insurance sector;
• incentives for members of the health workforce to focus on the provision of personalised medical devices to the detriment of other important health functions;
• an increase in trailing obligations for medical practitioners associated with longer-term care of patients fitted with personalised medical devices;
• pressure on the health system from overseas consumers attracted to Australia by a more rigorous regulatory regime for devices (“medical tourism”); and
• increased costs for government, especially where there are Commonwealth/State implications.

The majority of the stakeholders engaged indicated either they believed there would not be any impact, or were unclear as to whether there would or wouldn't be an impact. Some indicated they have yet to conduct any research on the impact of newer technologies on the health care system. A number indicated that it is a topic that they can see value in exploring further.

An experienced medical devices industry expert indicated that growth in the medical tourism industry in Australia is unlikely to be driven by personalised medical device regulation. Personalised medical devices are not peculiar to Australia, and some other challenges that might impede that growth include paperwork, approval processes and that the hospital system is not currently geared for medical tourism.

Some private hospitals indicated that they are likely to outsource personalised medical devices, including aids to implement surgery, to third-party organisations that are already performing this function.

In addition, a number of mechanisms to deal with changes already exist. For example, pathways for reimbursement of prosthesis already exist (where the device is on the Prosthesis List and included in the ARTG). If the number of prosthesis that meet this criterion were to increase, that might place additional pressure on the health insurance sector. The Department of Health Medical Services Advisory Committee pathway exists for managing changes, including changes to surgeon operation times.

Option 3 - Regulate custom-made medical devices in line with other medical devices

Under this option the exemption from inclusion on the ARTG for custom-made medical devices would be removed. This would mean manufacturers of custom-made medical devices would need to seek certification of their conformity assessment procedures, including demonstrating full compliance with the essential principles, to support the inclusion of these medical devices on the ARTG. Compliance with all the requirements of ARTG inclusion would also apply.

This would address the growing risks associated with the 'light touch' regulation of custom-made medical devices, including:

• Improved visibility: Inclusion on the ARTG would mean much greater TGA oversight of custom-made medical devices being supplied in Australia.
• Improved oversight: The requirement for conformity assessment certification would result in third party scrutiny of the conformity assessment procedure for all manufacturers of custom-made medical devices. These devices would also be required to comply with the essential principles (rather than the current requirement to document where they do not comply).
• Responsibilities associated with ARTG inclusion: Reporting of adverse events and annual reporting for high risk and implantable, record keeping requirements, powers of entry to manufacturer's premises and the compliance enforcement pathways (suspension or cancellation of an ARTG entry - which ceases the authority to supply the medical devices, and criminal and civil penalties under the Act) would all apply to these medical devices in full.

This option addresses Dimension 1 - Misalignment of regulatory oversight with level of risk quite well, in that regulatory oversight would be aligned with the risk of the medical device as it is for all 'mass produced' medical devices. The existing classification rules effectively and efficiency class devices according to risk, and existing conformity assessment requirements provide oversight in proposition to that risk. While there is always room for improvement, TGA proactively reviews and amends elements of the framework to ensure continued relevance and appropriateness.

However, this option does not effectively address the other two dimensions:

• Dimension 2 - Misalignment with international norms: The definitions and IMDRF definitions and examples (Appendix 1) is the emerging regulatory framework for personalised medical devices. In addition to being out of step with international regulatory norms, Australia represents only a small proportion of the global medical devices market (around 2 per cent). The Australian framework relies heavily on certification or approvals from comparable overseas regulators to facilitate access to medical devices, as eliminating duplicate assessment across jurisdictions reduces assessment costs significantly. Where Australian requirements vary significantly, even where manufacturers and sponsors could meet the Australian requirements, the cost of assessment to Australian specific requirements may be prohibitive.
• Dimension 3 - Need to balance risk with regulatory burden: In practice while patient-matched medical device may seek inclusion in the ARTG, many 'bespoke' custom-made medical devices would not be included on the ARTG due to associated costs. Instead these would cease to be supplied, or alternative supply pathways (explained below) would be used. This is not an appropriate balance of risk with regulatory burden. Personalised medical devices offer significant benefits to patients, the health system, and industry as this option would compromise access to many very promising emerging technologies.

Conformity assessment seeks assurance of safety, quality and performance of devices through systematic assessment of the manufacturing procedures, so manufacturers of bespoke custom-made medical devices may find this difficult or impossible to meet given their relative lack of systematic manufacturing processes.

Some larger manufacturers of patient-matched medical devices may meet manufacturing requirements. A number of existing patient-matched medical device manufacturers already have ISO13485 certification (on which conformity assessment requirements are based) however they may struggle with some of the additional requirements for conformity assessment, especially in relation to clinical evidence requirements (depending on the technology, it can be difficult or impossible to undertake clinical trials for 'one-off' medical devices). For more specialised and low volume medical devices, compliance would become increasingly difficult.

Without the proposed medical device production system (MDPS) no mechanism exists to recognise the emerging point-of-care manufacturing systems that are being marketed to healthcare providers, and that are intended to allow healthcare providers to produce medical devices for treating their patients.

Some personalised medical devices may be supplied under Special Access Scheme (SAS^[31]) or Authorised Prescriber (AP) arrangements. SAS and AP allow health practitioners to access therapeutic goods that are not on the ARTG and are not otherwise exempt from being in the ARTG. Supply of custom-made medical devices through this pathway would result in more limited oversight than existing custom-made requirements, as these arrangements are intended for exceptional clinical circumstances and tend to be ad hoc in nature.

Option 3 also does not address some of the deficiencies of the current custom-made medical device regulation framework, including:

• Providing for personalised anatomical models for investigating the anatomy and planning surgeries currently being required to undergo third-party scrutiny, unlike the requirements applied to now out-of-date analogue methods for achieving the same aim, such as X-ray film (Option 2D above)
• Clarifying requirements for medical devices that include a human-origin material component (Option 2E above). The existing biological framework for medical devices with human origin is confusing and costly. In addition, a number of devices aspects (engineering, production, device assessment) are not adequately covered where such medical devices are regulated as biologicals.

Potential flow-on effects

This option has significant limitations as outlined above, particularly in forcing many personalised medical devices from the Australian market. It does not satisfactory address the problem as outlined above, or deliver against two of the three dimensions on which these options are being assessed.

In addition to the impacts on manufacturers and suppliers of existing and future products, the lack of access to emerging personalised medical device technologies would have a profound impact for patients, health care professionals, the health sector and community. This impact would on grow over time, as emerging technologies continued to be developed but would remain largely inaccessible in Australia.

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