Regulatory Affairs Professionals Society 137 The European Medical Devices Legal System Updated by Gert Bos, PhD, FRAPS and Erik Vollebreg, LLM Chapter 13 OBJECTIVES T Gain insight into the European legislative process T Understand the basic legal requirements for medical devices T Become aware of available guidance concerning medical device requirements LAWS, REGULATIONS AND GUIDANCES COVERED IN THIS CHAPTER T Consolidated versions of the Treaty on European Union and the Treaty on the Functioning of the European Union, both last revised 26 October 2012 T Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC T Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 T Regulation (EC) No 764/2008 of the European Parliament and of the Council of 9 July 2008 laying down procedures relating to the application of certain national technical rules to products lawfully marketed in another Member State and repealing Decision No 3052/95/EC T Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices T Council Directive 93/42/EEC of 14 June 1993 concerning medical devices T Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices T Commission Decision of 19 April 2010 on the European Databank on Medical Devices (Eudamed) (2010/227/EU) T Commission Decision of 7 May 2002 on common technical specifications for in vitro diagnostic medical devices (2002/364/EC) T Commission Decision of 27 November 2009 amending Decision 2002/364/EC on common technical specifications for in vitro diagnostic medical devices (2009/886/EC) T Commission Directive 2005/50/EC of 11 August 2005 on the reclassification of hip, knee and shoulder joint replacements in the framework of Council Directive 93/42/EEC concerning medical devices
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