Is my product a medical device (MD)?
To know if your medical product falls within the scope of the CE marking legislation you must ensure if the product is classified as a medical device as defined in Directive 93/42/EEC.
In the Medical Devices Directive (93/42/EEC) a medical device is defined as:
“Any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for the 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 by such means.”
Several products may or may not be classified as a medical devices. This depends on the intended purpose of use, as determined by the manufacturer.
Here are some examples that can be classified as a medical device depending on the claim of the manufacture.
- dental sticks, dental floss, dental chewing gums;
- baby nappies, mattress protectors;
- contact lenses intended to provide color to the eyes;
- instruments for tattooing;
- deodorants for use with devices;
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