MEDICAL DEVICE REGULATIONS EVOLVE FOR AUSTRALIAN INNOVATORS WITH EUROPEAN AMBITIONS Notified body and approved body attend Regulatory Summit to support access to the EU market.
With
Gabrielle Cesvet,
Head of Public Affairs, Scarlet
Tirion Evans, Head of Technical Operations &
Head of Notified Body, Scarlet
SEGMENT
Filmed in Sydney | October 2026
Medical device regulation is undergoing significant change as regulators across major jurisdictions grapple with the rapid growth of software and artificial intelligence (AI) in healthcare.
Speaking with Australian Health Journal at the Medical Technology Association of Australia’s RegConnect Summit 2026 in Sydney in September, Gabrielle Cesvet, Head of Public Affairs at Scarlet, said manufacturers need greater clarity and sufficient lead time as new regulatory frameworks emerge.
“We need to make sure that from a regulatory perspective and from a conformity assessment perspective, we’re able to keep pace with that innovation,” she said.
Cesvet highlighted reforms underway in the European Union, including efforts to simplify the Medical Device Regulation (MDR), reduce regulatory burdens and create a framework better suited to software and AI. She also pointed to the UK’s plans to revamp its regulatory system and increase international reliance.
Tirion Evans, Head of Technical Operations and Head of Notified Body at Scarlet, said the company is increasingly working with Australian manufacturers seeking access to international markets. Scarlet operates as a Notified Body in the EU, an Approved Body in the UK and a Third Party Review Organization in the US.
Evans encouraged innovators to address regulatory requirements early rather than waiting until products are fully developed.
“The most important thing is to try and tackle the regulatory issues right at the beginning,” she said.
The interviews highlighted the growing importance of regulatory expertise in helping innovative software and AI medical devices reach markets efficiently while keeping pace with technological change.
- Source: Adapted from transcript using AI
- Media access credit: Medical Technology Association of Australia (MTAA), RegConnect Summit 2026, Sydney September, 2026
-
Op-Ed: CGT and proposed RDTI changes creating uncertainty in life sciences
Proposed Budget changes to the Research and Development Tax Incentive (RDTI) will disproportionally impact Australia’s biotech, medtech and health tech sector forcing more home-grown companies to consider moving overseas.
-
Medical research institutes association responds to draft national research strategy
On 27 August 2025, the Minister for Health, Disability and Ageing announced the release of the draft National Health and Medical Research Strategy (the National Strategy).
Involved in the initial consultation phase, was the Association of Australian Medical Research Institutes (AAMRI), the peak body for medical research institutes across Australia. Member institutes work on a broad spectrum of human health issues such as preventive health, chronic disease, mental health, immunology and Indigenous health. Their research ranges from fundamental biomedical discovery through to clinical research and the translation of research findings.
-
Reflections from the unstoppable giant in wound care
Professor Dr.Geoff Sussman holds a position in the Faculty of Medicine, Nursing and Health Sciences Monash University, and is the Adjunct Professor of Wound Care He is a wound consultant at the Wound Clinic Austin Hospital.
