Lecture

Medical Devices Regulation: Market Authorization and Compliance

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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 covers the general plan of the medical device regulation in Europe, including pre-market control, the 'New Approach', the central role of the manufacturer, and geographical scope. It also discusses the classification of medical devices based on risk levels, conformity assessment procedures, and the role of notified bodies. The 'New Approach' emphasizes legislative harmonization for safety and performance requirements, with voluntary application of harmonized standards. The lecture delves into the role of competent authorities, post-market surveillance, and corrective measures. It concludes with an overview of MedTech Europe's ethical code and self-regulation framework.

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