Medical Devices: European Regulations

This lecture provides an overview of the European regulations governing medical devices. It covers the classification of devices, the role of the manufacturer, post-market follow-up, and the importance of compliance with essential requirements. The instructor discusses the 'new approach' regime, the CE marking, and the geographic scope of the regulations. Additionally, the lecture delves into materiovigilance, corrective measures, and the reporting of incidents. It also touches on the ethical aspects of the medical device industry, including the MedTech Europe Code of Ethical Business Practice.