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.

Examples of Ancillary Medicinal Substances include:

During the certification process for devices with an ancillary medicinal substance, the Notified Body must review device aspects and seek the opinion of a European Competent Authority in relation to the ancillary medicinal substance incorporated in the device.

Prior to seeking the opinion of the Competent Authority, BSI must verify the usefulness of the medicinal substance incorporated in the device.

The Competent Authority will provide the Notified Body with a scientific opinion on the quality and safety of the substance taking in to account the clinical benefit/risk profile of the incorporation of the medicinal substance into the device.

The review of the medicinal substance by the Competent Authority may take up to 210 days and usually runs in parallel with the review of the device by the Notified Body.

BSI is very proud of our unrivalled history in certifying medical devices incorporating medicinal substances. With our extensive knowledge and experience in this area, BSI will provide you with timely, responsive and informed support at every stage of the certification process. Every case is different so feel free to contact us and we will be happy to discuss your individual circumstances.

Experience in drug device consultations