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Twists And Turns Ahead For Medtech In Europe As AI Dominates October Regulatory Debates

 
• By Amanda Maxwell

The regulation of artificial intelligence in medtech products is increasingly under the spotlight, in the EU and globally. A glance at October’s news sees a proliferation of schemes and actions to support medtech AI development in as safe and well-controlled an environment as possible.

AI Regulation
• Source: Shutterstock

Artifical Intelligence (AI) complicates the regulation and oversight of medtech products. And it is not the only new area of technology that is overlapping with medical devices and IVDs in the EU. Other horizontal existing and proposed regulations, namely the General Data Protection Regulation (GDPR), the AI Liability Directive, the Cyber Resilience Act, the Data Act, the Data Governance Act, the European Health Data Space Regulation (EHDS) and the revised Product Liability Directive are all adding to what many in the sector now describe as a “regulatory lasagna”.

To address this increasingly complex environment regulatory sandboxes are increasingly being suggested as a safe space for regulators, industry...

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