Module 18 2021

Borderlines with medicinal products

How can you decide?

Remember the definitions:

• A medicine works by exerting a pharmacological, immunological or metabolic action • A medical device does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means So: • If the primary action of the product is physical or mechanical , it is a medical device . • If the primary action is pharmacological, immunological or metabolic , it is a medicinal product .

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Classification Rule 13

Classification rule 13 states that: • devices incorporating as an integral part, • a substance which used separately, can be considered to be a medicinal product • which is liable to act on the human body with action ancillary to that of the devices • are Class III.

Key issues: Is the substance a medicinal product in its own right? Is the medicinal substance acting in an ancillary manner? Is it liable to act on the body?

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