EU and UK Regulatory Requirements - Implications for Innovation

Description

In this presentation, Dr. Suzanne Halliday discusses the complexities of global medical device regulation, highlighting discrepancies in device definitions, classifications, and safety testing requirements across various countries. She emphasizes the challenges faced by manufacturers who must navigate these diverse regulations to bring their products to market. The talk also delves into the European regulatory framework, particularly the role of the European Commission, competent authorities in member states, and notified bodies in ensuring compliance and safety for medical devices. Dr. Halliday notes the need for stricter pre-market controls and increased transparency through the European Database on Medical Devices (EUDAMED). Furthermore, she outlines the implications of recent UK regulatory changes post-Brexit, including the potential impact on UK products entering the European market and the transition away from European regulations. Finally, Dr. Halliday touches on the importance of innovation in the medical devices sector, stressing that regulatory considerations must align with technical feasibility and market viability.

DOI: 10.1302/3114-221022

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