Transcription of Table of Contents European Medical Device Regulation …
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Table of Contents European Medical Device Regulation …
Table of ContentsEuropean Medical Device Regulation 2017/745 The following 175 pages were published in the Official Journal of the European Union on 5 May 2017. This represents the entirety of the European Medical Device Regulation (2017/745). No changes have been made to the text. This Table of Contents was prepared by Oriel STAT A MATRIX and provides convenient links to specific Chapters and Annexes within the MDR. If you cannot locate the bookmark links on the left side of your screen, please click and definitions IArticles 1-414-21 Making available on the market and putting into service of devices, obligations of economic operators, reprocessing, CE marking, free movement IIArticles 5-2422-35 Identification and traceability of devices, registration of devices and of economic operators, summary of safety and clinical performance, European database on Medical devices IIIA rticles 25-3435-41 Notified bodies IVArticles 35-5041-50 Classification and conformity assessment VArticles 51-6050-56 Clinical evaluation and clinica
Regulation (EC) No 1223/2009 of the European Parliament and of the Council (2). (10) Products which combine a medicinal product or substance and a medical device are regulated either under this Regulation or under Directive 2001/83/EC of the European Parliament and of the Council. (3) The two legislative
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