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MEDICAL DEVICES

The principle of the European regulations is to allow free movement of medical devices in Europe, ensuring that only medical devices that meet the essential safety and performance requirements are placed on the market and put into service in Europe.

The manufacturer may choose the appropriate procedure from different conformity assessment procedures with reference to the applicable directive.
The term "medical device" is used to mean 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 principal 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…

(Definition concerning the directive 93/42/EC on medical devices).

The Directive foresees a classification of medical devices in four classes based on the risks that determine the conformity assessment procedures to be followed by the manufacturer.

Class I - Medical devices are regarded as “low risk” devices, e.g. non-invasive medical devices that do not touch the patient or only have contact with the skin. Pre-market notification is required prior to placing the devices onto the EU market.

Class IIa - Medical devices are regarded as “low-medium” risk devices, e.g. active therapeutic devices intended to administer or exchange energy in a non hazardous way. Certification by a Notified Body is required.

Class IIb - Medical devices are regarded as “medium-high” risk medical devices, e.g. active devices for monitoring of vital physiological parameters. Certification by a Notified Body is required.

Class III - Medical devices are regarded as “high-risk” devices, e.g. devices incorporating a medicinal substance. Certification by a Notified Body is required.

Medical devices and their accessories are covered by the Directive 93/42/EC, amendment by the 2007/47/EC.


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