Classification of medical devices with ancillary medicinal substances
Early classification of medical products containing or delivering drug substances is essential in order that the appropriate regulatory path is determined:
- Medical products designed to deliver drugs, supplied without the drug itself are regulated as medical devices, e.g. infusion pump.
- Medical products designed to deliver drugs, supplied with the drug combined, are regulated as medicinal products, e.g. sub-dermal contraceptive implants and insulin-filled syringes.
- Medical products which incorporate as an integral part a substance which, if used separately, can be considered to be a medicinal product and which is liable to act on the human body are regulated as Medical Devices, e.g. catheters coated with heparin.
To ensure an accurate classification you must consider the following questions:
- Whether any constituents, if used separately, may be considered to be a medicinal product, for example silver, some herbal ingredients, analgesics, etc.
- What claims are made for the product – what is the intended purpose?
- The method by which the principal intended action is achieved – mode of action?
- Liability of the medicinal substance to act on the human body.