Module 18 2021

Borderlines with Medicinal Products

Most (if not all) medical devices will ‘fit’ the definition of a medicinal product at least under the first part.

Thus determining whether a product is a medical device or a medicinal product can be a complex process.

Key areas:

• Mode of action (pharmacological, immunological, metabolic or physical?) • The intended purpose for the product • The claims being made for the product • The ingredients contained in the product

27

27

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)

28

28

14