Module 18 - Drug Device Combinations and Other Technologies

Borderlines

Key determination factors: • manufacturer’s intended purpose for the product • associated claims • product’s mode of action

It is possible to argue that almost anything is a Medical Device

To be a Medical Device:

• The product must fit the definition of a medical device; • The product must have an appropriate mode of action; and • There must be a ‘medical purpose’ for the product.

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Borderlines

Not everything used or intended to be used in a healthcare environment are medical devices:

Patient identity bracelets, chairs for use in surgeries and hospitals (note: dental chairs may be MDs), healthcare professionals’ clothing (except sterile theatre drapes etc), porters’ chairs (wheelchairs for transporting patients), portable ramps, pyjamas and other bedclothes or materials claiming anti-microbial action

Things for use in the home or at work may be medical devices:

Hypo allergenic bedding, orthopaedic mattresses (with specific claims)

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