Module 18 2021

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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Multiple Choice!

Some products could come under various regulations – e.g. medicinal product, medical device, biocide, cosmetic, general products. The key to these determinations will depend upon the product’s mode of action and intended purpose.

e.g.: Eye drops

Emollient Creams Hand sanitizer

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