The Regulations for medical devices and in vitro diagnostic medical devices were published in the Official Journal of the European Union on 5 May 2017, and they entered into force 26 May 2017. A regulation is a legal act of the European Union that becomes immediately enforceable as law in all Member States simultaneously.
This book gives guidance on the definitions, the key concepts and the main elements. The intention is to provide an introduction that supports the further reading of the challenging content of the Regulations.
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The writer worked for the Finnish competent authority for medical devices from 1992 till 2006. Despite the change into another job he kept following actively the development of the EU regulatory system. Since 2005 he has regularly given lectures in a course on regulatory requirements for medical devices at Tampere University of Technology and Tampere University of Applied Sciences.
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