Module 18 - Drug Device Combinations and Other Technologies

Borderlines with medicinal products

There are two main borderlines with medicinal products.

1. A single product intended for a medical purpose, where it is not immediately clear whether it should be classed as a medicinal product or a medical device. 2. A combination product which includes a medical device component and a medicinal product component, e.g. i. Intravascular stents which have been coated with heparin (which prevents blood clots forming on the stent) ii. Subdermal contraceptive implants (a small device slow releasing a medicinal product)

27

27

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 .

28

28

14