The Medical Devices Introductory Course 2020

Medical device or Medicinal Product ? Depends on the mode of action that achieves product indication

Primary Intended Purpose achieved by one of the following means:

Primary intended purpose achieved by other means:

Physical / Simple Chemical

Pharmacological / Metabolic/ Immunological All ATMPs All In-Vivo Diagnostics

Mechanical / Digital

Medical device

Medicinal Product

Ancillary Drug

Deliver/ Localise

Device-Drug Combination

Drug-Device Combination

The Organisation for Professionals in Regulatory Affairs

What regulatory pathway for these products?

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