Not a new trend, but still prevalent: products that are a combination of a medical device and a medicinal product. Most nuances in the regulation of these products arise when they exist as integral products. When deciding on the regulatory status of such a combination, the most important step is to determine the principal intended action of the entire product. If the principal intended action of the integral product is achieved by the medicinal substance through pharmacological, immunological, or metabolic means, the entire product is regulated as a pharmaceutical product. However, if the principal intended action is achieved by the medical device, the entire product is regulated under the MDR.
A representative example is wound dressings containing a matrix and an antimicrobial agent. If such wound dressings are used primarily for providing a barrier function, and the antimicrobial agent has an ancillary action on the wound, the product is regulated as a medical device. On the other hand, if the primary action of the wound dressing is to administer the antimicrobial agent to the wound for the purpose of controlling infection, and the purpose of the matrix is to administer medicinal products, this combination product is regulated as a medicinal product.
While it may seem clear, there are still some nuances for this type of product. Not all cases of similar products allow the matrix used as part of a medicinal product to be classified as a medical device.
To satisfy the definition of a medical device, the matrix part of the finished product must have an independent medical function of its own. In the case of wound dressings, the matrix is involved in the treatment process by specifically administering the antimicrobial agent directly to the wound to control infection, while also acting as a physical barrier to protect the wound.
From this perspective, an interesting example is the regulatory classification of transdermal patches. There is a category of patches for transdermal drug delivery based on passive diffusion. In this case, the patch components are designed solely to aid the delivery or release of the drug without performing a medical action on its own. Thus, it is classified as an excipient of the finished medicinal product and must comply with pharmaceutical quality standards. However, there is a category of patches that use active mechanisms of drug delivery, such as iontophoretic, microneedle, or electrochemical patches. The patch component in these products performs an independent medical function, such as actively controlling drug release, enhancing skin penetration, or modulating absorption. Thus, it will be classified as a medical device. However, since the primary intended action if this integral product is performed by the medicinal substance, the entire product will be regulated as a medicinal product.
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