- Products which are designed to deliver medicines which are supplied combined with the medicine e.g. pre-filled insulin syringe – these are regulated as medicinal products
- Medical devices which incorporate a substance which if used separately is classified as a medicine and the action of the medicine is ancillary to that of the device e.g. drug-eluting stent, bone cement containing antibiotic
- How does the product achieve its intended purpose?
- What is the primary mode of action?
- Liability of the medicine to act on the human body