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COUNCIL DIRECTIVE 93/42/EEC - Medical Devices
‘medical device’ means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes.
COUNCIL DIRECTIVE 90/385/EEC - Active Implantable Medical Devices
‘active implantable medical device’ means any active medical device which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure.
DIRECTIVE 98/79/EC - in vitro Diagnostic Medical Devices
‘in vitro diagnostic medical device’ means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body.
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Press Release 3
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