Lecture

Medical Devices: European Regulations

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In course

BIO-455: Introduction to law and ethics

The aim of this course is to introduce students to the basic legal and ethical concepts relevant to research in the life sciences and its translational application, and to provide them with the essential tools to identify legal and ethical issues in their ...

Description

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.

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