Medical Devices - Quality Management Systems, Risk Management and Terminology

The European Medical Device Directive (93/42/EEC), states a medical device is:

"any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of:

• Diagnosis, prevention, monitoring, treatment or alleviation of disease
• Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap
• Investigation, replacement or modification of the anatomy or of a physiological process
• Control of conception.

. . . and which does not achieve its principle intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means . . .".

Key Publications:

BSI British Standards also publishes Standards on:

• In vitro medical devices
• Packaging for medical devices products and healthcare
• Sterilization of medical devices and packaging.