Overview

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.

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9781774694114

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Shalinee Naidoo is currently the Regulatory and Product Development Manager of a medical device manufacturer based in South Africa. She is directly involved in global regulatory compliance and the design and development of new medical devices from idea conception to market. She is also the founder of Life of Shal (www.lifeofshal.com) an online travel journal created to inspire others to explore the world and Scientist's Sanctuary (www.scientistssanctuary.com) - a science communication company that specializes in bridging the gap between scientific knowledge and creative communication for both the academic and corporate world.

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