Scope

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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