The Medical Devices Introductory Course 2020

EU Legislation

• Combinations of devices and medicines are common but there is no “combination product” classification • A “combination” product is EITHER regulated as a medicinal product or a medical device • The Classification as either a drug or device depends on the principal mode of action & intended use of the product • Need to determine the appropriate regulatory route early in product development

The Organisation for Professionals in Regulatory Affairs

Types of combinations of a drug and device

No Type

Example

1. Device to administer a drug (not integral part of the device) but cross labeled or co-packaged with the device

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

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

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

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

The Organisation for Professionals in Regulatory Affairs