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About Eu Reg Module 9 Notes
This document provides an overview of medical device regulation in the European Union. It describes the EU medical device directives, which are transposed into national laws. Devices are classified based on risk level, with regulatory requirements proportional to risk. Key aspects of the directives include competent authorities that oversee compliance in each EU member state, notified bodies that certify medium and high risk devices, and the CE marking process manufacturers must undergo to demonstrate a device meets essential safety and performance standards. The overall aim is to harmonize controls while allowing for the free movement of safe and effective medical devices across the EU.
Detailed Information
| Author: | ['Henry Spencer'] |
|---|---|
| Publication Year: | 2018 |
| Pages: | 18 |
| Language: | English |
| Format: | |
| Price: | FREE |
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