Module 18 - Drug Device Combinations and Other Technologies

Borderlines

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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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