Critical Medical Device Series: Part VIII Regulatory Strategies in Europe for MedTech

Understanding the evolving MedTech regulatory landscape in the European Union is essential for companies operating in or expanding into Europe. The EU Medical Devices Regulation and In Vitro Diagnostic Regulation set out complex guidelines around the scope of the requirements, data required for conformity assessment, economic operator roles, and use of devices in clinical trials, alongside new challenges posed by the Artificial Intelligence Act and other overlapping legislation.

Arnold & Porter partners Jackie Mulryne, Alexander Roussanov, and Phil Desjardins will guide attendees through the latest developments in the EU to assist your regulatory strategy, including transition timelines, understanding your role in the supply chain, notified body bottlenecks, and the implications of artificial intelligence integration in medical devices. In this webinar, we will provide practical insights and guidance for navigating compliance across jurisdictions, managing supply chains, and aligning global development strategies.

This session will be particularly valuable for regulatory affairs professionals, legal advisors, and executives overseeing EU market access, and will help you stay ahead of compliance obligations and mitigate commercial and legal risks in a rapidly changing environment.

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