Proposed regulatory options for medical devices containing nanomaterials

The Therapeutic Goods Administration (TGA) published the Consultation: Proposed regulatory options for medical devices containing nanomaterials in February 2021. This paper called for interested stakeholders to present their views on possible options for aligning the Australian medical device regulatory framework with the European Union (ED) framework for medical devices containing nanomaterials. The consultation closed in April 2021.

The TGA received seven submissions from the four medical device industry stakeholders, one medical professional association, one university, and one private individual.

Individual submissions will not be published for this consultation, due to the small number of responses and lack of publication permission from the respondents.

Submissions from the medical devices industry generally agreed that, for practical purposes, Australian medical device regulations should be aligned with European medical device regulations. Submissions received from the medical devices industry noted that this alignment would assist in reducing the regulatory burden and effort required from industry and would speed up patient access to medical devices and nanotechnologies. The medical professional association submission noted that it is presently unclear which definition is best suited for an Australian regulatory framework and sought further explanation as to why the EU definition would be selected for use in Australia.

There was general support from the medical device industry, the medical professional association, and the university for the adoption of Option 2 in the consultation discussion paper - making requirements explicit - which would add definitions and amend the Essential Principles. Submissions from industry and the university suggested that, as well as aligning the Australian medical device regulations with the European medical device regulations, Australia should add definitions to provide clarification of responsibilities for sponsors and manufacturers, greater legal certainty and to ensure a high level of health protection. The submissions also recommended that the Essential Principles in Australian medical device regulations be amended to include nanotechnologies.

It was noted in submissions from the medical device industry, the medical professional association, and the university that there are difficulties with defining and measuring nanomaterials, issues related to particle size, and limited manufacturing data on nanomaterials. Expert opinions were provided in these submissions for risk classifications, safety assessments and the regulation of medical devices with nanomaterials.

Submissions varied on whether new classification rules are needed (as outlined in Option 3 of the consultation paper). Two submissions recommended new classification rules to evaluate nanomaterials and reflect nano-specific issues.

Submissions from the medical device industry did not recommend consideration of the potential to generate nanoparticles through wear or degradation when classifying medical devices or developing new rules for nanomaterials, noting the position of the MedTech Europe special interest group on nanomaterials. The submission from the university noted that abrasive wear of devices may generate nanoparticles and that the related chemical activity of these nanoparticles should be a focus for industry. One submission considered that an additional clause related to the risk of generating nanoparticles from new devices should be included due to the potential of inducing harm to users. Another submission considered it would be helpful to distinguish between nanoparticles not known to be absorbed versus those with absorption potential, and that systemic exposure should be evaluated for each individual case.

Submissions from the medical device industry generally agreed that a staggered approach would be needed for transitional arrangements to align with the European medical device regulations transition times. Recommended transition times varied from a 12-month post European medical device regulations transitional period,(one submission) to a three-year transition period (two submissions).

Submissions from the medical device industry, the medical professional association and the university also noted the need for guidance and training material for clinicians, manufacturers, and sponsors to set standards and to assist in obtaining TGA approval for these medical devices. It was also noted in submissions from the medical professional association and university that continued consultation with stakeholders and updated guidance would be needed for new developments and as understanding of nanomaterials increases over time.

The submissions to the public consultation indicated that Option 2 would provide both clarity and flexibility to a broader range of relevant stakeholders.

To this end, as outlined in the consultation paper, the TGA will:

• seek amendment of the Therapeutic Goods (Medical Devices) Regulations 2002 to:
  • include proposed definitions of nanomaterials
  • make changes to the Essential Principles to provide further clarity in relation to nanomaterials, in line with European requirements.
• prepare guidance material to provide clarification about the regulation of medical devices containing nanomaterials