Module 18 - Drug Device Combinations and Other Technologies

04/12/2023

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What is a Combination Product in the EU?

• Combinations of devices and medicines are common • There is no “combination product” definition in the EU • A marriage of two very different areas which can include complex technology • A “combination” product is EITHER regulated as a medicinal product or a medical device • The Classification as either a medicinal product or medical device depends on the principal mode of action & intended use of the product • Need to determine the appropriate regulatory route early in product development

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Types of potential combination products

No Type Device to administer a drug (not integral part of the device) but cross labeled or co-packaged with the device 1.

Example

Device and drug are integral (but not reusable) product. 2.

Device and drug as integral product where the action of the drug is ancillary. 3.

Device and human blood-derived substance (ancillary) as integral product. 4.

Device combined with an Advanced Therapy Medicinal Product (ATMP). 5. Companion diagnostics (CDx): In vitro diagnostic which provides information about drug with which it used. 6.

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