action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;"

EU Legal framework

Based on the New Approach, rules that relate to safety and performance of medical devices were harmonised in the EU in the 1990s. The New Approach, defined in a European Council Resolution of May 1985, represents an innovative way of technical harmonisation. It aims to remove technical barriers to trade and dispel the consequent uncertainty

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