Scope under the Medical Device Directive

Devices which fall under the directive include:

Any device,  apparatus, appliance or material used on human beings for the purpose of  diagnosing, treating, preventing, monitoring, or alleviating a person’s  condition as well as in conjunction with those who are injured or  handicap. A medical device can also be defined in this directive as any  of the previously listed in concurrence with conception. If any of these  relate to your device, it is classified as a medical device.


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