European Law of Medical Devices

This lecture provides an introduction to the European law of medical devices, covering topics such as the definition and classification of medical devices, the regulatory regime in Europe, the role of the manufacturer, post-market follow-up, and the importance of compliance with essential requirements. It also discusses the central role of the manufacturer, the classification of medical devices based on risk, the conformity assessment process, the CE marking, and post-marketing surveillance. Furthermore, it explores the ethical considerations in the medical device industry, including relationships with healthcare professionals and organizations, transparency in agreements, and the medtech Europe code of ethics.