Europe Announces AI Act Enforcement Plans for Medical Devices

Europe is advancing with the implementation of its AI Act, which will impose new compliance requirements on high-risk AI medical devices and require coordination with national authorities and third-party certifiers, raising concerns among manufacturers about regulatory burdens. EU member states are also grappling with potential conflicts between the AI Act and existing data protection laws like GDPR, emphasizing the need for clear legal guidance and systematic cooperation to avoid inconsistent regulatory outcomes. Meanwhile, the U.S. has prioritized fostering AI innovation over regulation, contrasting with the European approach. In financial services, regulators like the UK's Financial Conduct Authority are engaging stakeholders and piloting collaborative initiatives to explore AI's benefits and inform future regulations. Across sectors, organizations are leveraging AI to enhance agility and compliance, but the adoption of these technologies introduces new risks and complexities that add to the compliance burden. The global regulatory landscape remains fragmented, compelling businesses to adapt to diverging standards and evolving technological risks.