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Life Sciences Newsletter No. 4

Life Sciences Newsletter No. 4

13/07/2017 - Author: Ángel García Vidal

Life Sciences Newsletter No. 4At present, medical devices are regulated in the EU by three directives dating back to the 1990s: (a) Council Directive of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (90/385/EEC), (b) Council Directive 93/42/EEC of 14 June 1993 concerning medical devices; and (c) Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices.


Although the above directives have been the subject of subsequent amendments (notably, by way of Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007), the fact is that technological progress has highlighted the need for revision of current legislation. And to this we must add the existence of a number of scandals concerning medical devices, such as the faulty PIP breast implants...

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Life Sciences Newsletter No. 4