In 1985, the European Council defined the ‘New Approach’ - an innovative methodology of
technical harmonisation designed to remove barriers to trade and facilitate the free
movement of goods with the European Union. In the spirit of this new approach, rules
governing the safety and performance requirements of medical devices were introduced in
the 1990s. Subsequently, the three core directives published by the European Council then
had to be transferred into the national legislative systems of all EU member states.
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