Medical Devices

The main Directive 93/42/EEC covers the sales and marketing of Medical Devices.  This Directive has had several amendments the most recent being Directive 2007/47/EC which came fully into force on 21 March 2010.  In this latest Directive, a "Medical Device" is defined as:

"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 and 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."

Examples of Medical Devices are as follows:

• first aid bandages
• tongue depressors
• implants
• X-ray equipment
• spectacles
• dental materials

Please refer to our regulatory services for further information or contact us with your specific regulatory compliance requirements.