Devices Incorporating Medicinal Substances
Overview
When a medical device incorporates a medicinal substance as an integral part that, if used separately, would be considered a medicinal product, and the substance is liable to act on the human body with an action ancillary to that of the device, the device is classified as Class III under MedDO Rule 14.
Conformity Assessment Requirements
The manufacturer must: conduct a benefit-risk assessment specific to the medicinal substance; assess the quality, safety, and efficacy of the medicinal substance taking into account the intended purpose of the device; include in the technical documentation data demonstrating the quality, safety, and efficacy of the medicinal substance; obtain a scientific opinion from Swissmedic's drug division (not from an EU competent authority, as Swiss authorisation is independent) on the quality and safety of the medicinal substance.
Swissmedic Drug Division Consultation
For devices incorporating a medicinal substance, Swissmedic may consult its drug division as part of the registration review. Manufacturers should proactively engage with Swissmedic on the ancillary medicinal substance assessment approach early in the development process.
Examples
Drug-eluting stents (paclitaxel, sirolimus), antibiotic-impregnated bone cement, heparin-coated catheters, silver-containing wound dressings (where silver acts ancillarily).
Official Sources
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Manufacturers should submit a request for scientific opinion early in development, ideally before final conformity assessment documentation is completed. The request should include: detailed characterisation of the medicinal substance; quality data; pharmacology and toxicology summary; intended clinical use and benefit-risk assessment. Swissmedic typically provides the opinion within a defined timeframe as part of the overall registration assessment.