Based on the New Approach, rules relating to the safety and performance of medical devices were harmonized in the EU in the 1990s.
The core legal framework consists of three directives:
Those "Medical Directives" were enacted to provide for a harmonized regulatory environment for all medical devices sold within the European Economic Area.
They aim at ensuring a high level of protection of human health and safety and the good functioning of the Single Market.
All products which fall within the scope of Directives must meet certain essential safety and administrative requirements and are to be CE marked to show that they comply.
Such products may then be freely sold throughout the EEA.
These three 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.