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Submissions received: Proposed refinements to the regulation of personalised medical devices

25 August 2021

The TGA thanks respondents who provided a submission in response to the public consultation paper Proposed refinements to the regulation of personalised medical devices.

This consultation related to the implementation of the new framework for the regulation of personalised medical devices which commenced on 25 February 2021, including a transition period for eligible manufacturers and sponsors until 1 November 2024.

During the implementation phase a number of sectors have raised concerns over the impact of the new framework. We sought feedback on potential refinements to the Framework that could be considered to ensure risks associated with personalised medical devices are appropriately mitigated without imposing unnecessary administrative and regulatory burden.

There were three main proposals outlined in the consultation:

Proposal 1: Exclusion from TGA regulation entirely for products that do not meet the definition of a medical device but for which clarification of regulatory status would be beneficial and/or products that are very low-risk accessories to medical devices.

Proposal 2: Exemption from TGA pre-market regulation for Class I non-sterile, non-measuring medical devices produced by suitably qualified, accredited professionals and/or where there are already other third-party mechanisms of oversight in place suitable to manage the risks posed by the products.

Proposal 3: Alternative conformity assessment procedures for Class IIa medical devices produced by suitably qualified, accredited professionals and/or there are already other third-party mechanisms of oversight in place suitable to manage the risks posed by the products.

A total of one hundred and thirty-seven (137) submissions were received.

Summary of feedback

We received 137 responses from a variety of stakeholders including public and private hospitals, state and territory governments, other government agencies, 24 peak bodies, health practitioners and suppliers, across a number of clinical domains including audiology, dental, obstetrics, osteopathy, prosthetics, allied healthcare, nursing, occupational therapy, physiotherapy, rehabilitation and podiatry.

There were a range of views across and within sectors, with some wanting across the board removal of regulation and others an increase in regulation above what was proposed.

While there was broad support for the three proposed refinements, very few respondents offered evidence or commentary to demonstrate that devices would continue to be safe and fit for their intended purpose if these proposals were progressed. Respondents who opposed the proposals also provided strong arguments linked to the safety and efficacy of medical devices, and the need for TGA regulation.

A number of other issues were identified a preferred option to regulate some materials and components as medical devices, particularly where these products are used by healthcare practitioners or trained technicians at the instruction of, or to a written request received from, a healthcare practitioner.

While the majority of respondents supported all proposals, there were a number of issues with the responses including:

  • Low levels of understanding of how the TGA regulates (and therefore some of the proposals).
  • Failure to provide evidence or commentary supporting the proposals via demonstration that mechanisms used to exempt devices or provide alternative routes for conformity assessment would still ensure devices are safe and fit for their intended purpose.
  • Reiteration of their beliefs that the TGA should not regulate them and/or low risk devices at all.
  • Many of the comments from respondents who claimed to support the proposals actually expressed caution about the proposals. In short, these respondents do not want to be regulated but think it is important that the devices are independently assessed and monitored for safety and performance.

Responses also indicated that no single sector of the healthcare industry is currently regulated or accredited in a manner that ensures the devices made by practitioners meet the Australian regulatory requirements for medical devices. Many stakeholders, including those generally supportive of the proposals, provided feedback indicating limited awareness that if professional or peak bodies were to guarantee the quality and safety of the devices manufactured by their members, additional measures may need to be implemented before those bodies could guarantee the work of the practitioners or providers registered and/or accredited by them.

A smaller number of respondents disagreed with the proposals but the majority of these respondents demonstrated a very good understanding of the regulatory framework for medical devices and made strong safety-related arguments supporting their position.

Proposal 1 - Exclusion

Broad support for the exclusion of some products was expressed by many stakeholders. Key themes from comments made in the responses include:

  • Exclusion should be used to provide clarity only, and should be limited to products that don't meet the definition of a medical device.
  • Exclusion of some devices is preferred, but only where they are manufactured by particular people including health professionals.
  • The concept of medical devices devoid of risk is a fundamentally flawed and potentially dangerous assertion.
  • Some respondents also argued that rather than excluding products, TGA should be declaring some products to be medical devices.

Proposal 2 - Exemption

While the majority of respondents agreed with the proposal to exempt, often citing the financial and administrative burden of including devices in the Australian Register of Therapeutic Goods, very few provided supporting comments or evidence to support their position. Most reiterated the general points made in the consultation paper and some agreed in principle but expressed concerns and doubt that an appropriate mechanism for exempting devices exists. There was broad support for the refinements, but no comments with respect to which registered healthcare professionals manufacture medical devices as part of their existing scope of practice.

A number of respondents also indicated that any exemption given would likely result in a drop in levels of compliance, safety, quality and outcomes for patients.

Other concerns expressed by respondents include:

  • The scope of the exemption may be biased against self-regulating health professionals or health professionals who choose not to become a member of an accrediting body.
  • The exemption should only be available to domestic manufacturers.
  • What measures could be used to make sure exempt healthcare professionals have appropriate training and qualifications.
  • Inability to advertise exempt devices and the impact of exemption on reimbursement pathways.
  • Some respondents recommended measures be put in place to review the exemption periodically and adjust it as required to ensure ongoing currency.
  • Some respondents cited current compliance issues in the healthcare as evidence that self-regulation would be inappropriate. Others argued that other regulators and accrediting bodies are not appropriately qualified to manage the responsibility of assessing devices. There were arguments against factoring a healthcare professional's clinical judgment into the risk management process, citing it was inappropriate for them to assume responsibility for ensuring the device is designed and manufactured appropriately.
  • Providing an exemption would undermine research and development, stifling innovation.

Proposal 3: Alternative conformity assessment procedures

As with Proposal 2, many respondents agreed with Proposal 3, but very few provided supporting comments or evidence to support their position, generally reiterating points made in the consultation paper. Some agreed in principle but expressed concerns including:

  • Multiple respondents called for alternative conformity assessment procedures to be available to all manufacturers, not just those who manufacture patient-matched devices.
  • Allowing some devices to be manufactured using alternative conformity assessment procedures could threaten mutual recognition agreements with other countries and limit trade opportunities.
  • A number of respondents claimed the risks associated with Class IIa devices cannot be appropriately managed with self-declaration for conformity assessment.

Crucially, none of the peak industry or professional bodies provided evidence or commentary in their response to the consultation demonstrating that meeting the Australian regulatory requirements for medical devices forms part of the accreditation or registration requirements for their members.

Alternative approaches

Some respondents proposed a number of alternatives including:

  • Regulating materials and components where they will be used by healthcare professionals or in devices made to the written request of a healthcare professional.
  • Revising the current conformity assessment procedures and:
    • Using templates to help manufacturers with their conformity assessment; and
    • Finding ways to reduce the cost of conformity assessment including using the proposed templates or conducting conformity assessment that better assesses the risks associated with a device and the "gap" left by other mechanisms for oversight (for example, allowing a reduced version of conformity assessment in a public health setting where ISO 13485/9001 is in place and adverse events are managed through hospital reporting systems);
  • Standardising and regulating the qualifications of health professionals who recommend and/or manufacture patient-matched medical devices, and/or manufacturers who are making a device according to instructions received, or a written request, from a healthcare professional.
  • Allowing the use of generic GMDN Terms to minimise the kinds of device that a manufacturer is required to include;
  • Tethering TGA-related regulatory costs to supply, to take into account low-volume supply of patient-matched medical devices;
  • Finalising implementation of the medical device production system (MDPS) concept;
  • Reviewing the classification rules as they apply to medical devices intended for use in the oral cavity; and
  • Allowing state and territory government health departments take on the legal role and responsibility of all medical devices produced within the facilities that operate under their jurisdiction. This would cover any after-care following discharge.

Other themes

Other themes that emerged from the consultation include:

  • Medical devices manufactured by a healthcare professional or an individual working to a written request from, or at the instruction of, a healthcare professional present a different risk profile to mass produced devices as they are made in a fundamentally different way that does not fit with the current framework for regulation (i.e. the risks are different, the design of the device is not the responsibility of the "manufacturer", etc.) More work is needed to understand how these devices are manufactured and to ensure the risks are managed throughout the design, development and manufacture of the device.
  • There is a need for a mechanism for low volume devices to be supplied without being required to undergo full conformity assessment and inclusion in the ARTG as the literal impact of the costs is that these devices can no longer be legally supplied.

Submission received

One hundred and thirty-seven (137) submissions were received from a variety of stakeholders including public and private hospitals, state governments, peak bodies, health practitioners and suppliers, across a number of clinical domains including audiology, dental, obstetrics, osteopathy, prosthetics, allied healthcare, nursing, occupational therapy, physiotherapy, rehabilitation and podiatry.

Submissions that gave permission to be published are available below in PDF format. If your submission is not here and it should be, or if information has been redacted that you think should be included, please contact personaliseddevices@health.gov.au

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