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
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