In the name of Allah the Merciful

The Medical Device Handbook For Europe

Shalinee Naidoo, 1774694115, 9781774694114, 978-1774694114

English | 2022 | PDF

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As the medical device landscape continues to evolve, so does the  regulatory framework in Europe. Through this process many gaps and  scarcity of skills and expertise have also been identified. For this  reason, there was an increasing need to update the current medical  device directive (MDD 93/42/EEC) being used within the European Union.  This in turn led to the development and release of the Medical Device  Regulation (EU MDR 2017/745). The release of the new Medical Device  Regulation (EU MDR 2017/745) in 2017 marked the start of a three-year  transition period for various Economic Operators along the supply chain.  This volume aims to provide a simple overview of the medical device  industry in Europe with particular focus on the main aspects covered in  the new European Medical Device Regulation. Important concepts such as  essential phases in a device lifecycle, complying to standards and  regulations, the CE mark process and classification of medical devices  in Europe are covered.