Module 18 - Drug Device Combinations and Other Technologies

What is a biocidal product?

- any substance or mixture, in the form in which it is supplied to the user, consisting of, containing or generating one or more active substances, with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action, - any substance or mixture, generated from substances or mixtures which do not themselves fall under the first indent, to be used with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action. A treated article that has a primary biocidal function shall be considered a biocidal product. - Regulation (EU) No 528/2012

In short , a biocide has an antimicrobial effect which is not purely physical or mechanical.

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Borderlines with biocides

Realistically the only device borderline will be disinfectant products.

Medical device: If specifically intended to disinfect medical devices

Biocide – if intended for general use (walls, floors etc) whether in the home or in a healthcare institution or – if intended as general disinfecting hand wash

Medicinal product If intended for a medical purpose (surgical scrubs, pre-injection swabs)

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