Can distilled water be certified as a medical device?

Ronen E

Problem Solver
Staff member
Moderator
#11
Hi lyannastark,
Below is the definition of medical device from the European directive:

"‘medical device’ means 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;"


As you can see - distilled water by itself is not a medical device.

Cheers,
Shimon
(My emphasis)

Why not? It’s intended for prevention of disease.

Good question. It's not a device by itself; it's not a drug; and it's not a cleaning & disinfetion agent per se. But often it is used as part of a cleaning procedure. To my knowledge there is no specific classification for it.


-Shimon
(My emphasis)

Yes it is a cleaning agent (though not a disinfection one).
 
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