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News & Trends - MedTech & Diagnostics

Regulatory pathways must keep pace with digital innovations in diagnostics and medtech

Health Industry Hub | October 4, 2022 |

MedTech News: The International Medical Device Regulators Forum (IMDRF), hosted by the Therapeutic Goods Administration (TGA), took place in Sydney in mid-September and attracted over 200 stakeholders virtually and more than 100 participants in person.

Regulators, industry representatives and standard organisation representatives including Pathology Technology Australia, Medical Technology Association of Australia (MTAA) and AusBiotech shared their experience and challenges with the existing standards as well as the speed of reviewing or developing new standards, and the need for state-of-the-art technology evaluation processes.

There were discussions on health software versus medical device software and that some software developers are new to medical device regulations. Participants also discussed transparency, governance and the need for a common understanding of terms. The panellists exchanged views on the appropriateness of specific standards that support medical device life cycle approaches.

Dean Whiting, CEO of Pathology Technology Australia, told Health Industry Hub “The key highlights for in vitro diagnostics (IVDs) relate to the steep learning curve for some European manufacturers to come to terms with the In Vitro Diagnostic Medical Devices Regulation (IVDR) legislation, and that only 7 of the 39 notified bodies are currently approved to certify IVD manufacturers. This could explain the significant delays in TDARs that are meant to be issued with CE Certificates.”

While the European Union’s IVDR is now in effect, stakeholders continue to be concerned that the road forward is not going to be easy, especially due to the lack of notified body capacity to handle the influx of conformity assessments necessitated by the new regulation.

Attendees at the IMDRF shared their perspectives on the current and emerging AI and medical device technologies. There was a recognition of the growing use of AI in clinical settings and trends emerging such as cloud use, integration between hardware and software and AI underpinning population health management and precision pathology. The panellists shared their perspectives on the benefits and risks, challenges and potential regulatory approaches for these technologies. There was also a recognition that some stakeholders may not appreciate the limitations of AI and the unintended bias.

Mr Whiting added “In looking ahead, the biggest trends are those related to information based technologies. AI and machine learning based technologies are coming thick and fast. These technologies have the potential to vastly improve the quality of healthcare by accurately targeting diagnosis and treatment options to the right patient. The challenge for regulators is the speed with which these are arriving and the volatile nature of the technology with continuous iterations that ‘learn as they go’.

“The recommendation I have made is that current regulatory overlays may be challenged by such technology and that a ‘light touch’ regulatory response might be the preferred approach. The regulatory oversight should be focussed on the in-market performance by way of real time reporting and monitoring.”

IMDRF, established in October 2011, is a voluntary group of medical device regulators from around the world who have come together to build on the strong foundational work of the Global Harmonization Task Force on Medical Devices (GHTF) and aims to accelerate international medical device regulatory harmonisation and convergence.


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