Module 18 2021

What is a Borderline ?

Borderline products are those where is it initially unclear what regulations should apply to the specific product.

• Could it be a Medical Device? • Does it fit the definition?

• What is the intended purpose? • How does it work? (physically?) • Is it clearly ‘something else’ (e.g. a medicinal product). • What other regulations might apply?

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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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