Regulatory framework for medical devices

Based on the New Approach, rules relating to the safety and performance of medical devices were harmonised in the EU in the 1990s. The core legal framework consists of 3 directives: Directive 90/385/EEC regarding active implantable medical devices, Directive 93/42/EEC regarding medical devices and Directive 98/79/EC regarding in vitro diagnostic medical devices. They aim at ensuring a high level of protection of human health and safety and the good functioning of the Single Market. These 3 main directives have been supplemented over time by several modifying and implementing directives, including the last technical revision brought about by Directive 2007/47/EC.

The link address is: http://ec.europa.eu/health/medical-devices/regulatory-framework/index_en.htm