Medical devices and medicinal products are two completely differently regulated categories of products that cannot be mixed and confused. However, there are three so-called "intersecting" product groups between these categories. The one most frequently discussed, especially by medical device manufacturers, is devices containing, as an integral part, a medicinal product as an excipient. This type of product is regulated by Regulation (EU) 2017/745 ("MDR"). In case of these type of medical devices, the pharmacological, immunological or metabolic function can only produce an ancillary effect that is complementary to the physical effect of the medical device. In the past, these types of devices have been variously speculated by some manufacturers in an attempt to keep them in lower risk classes. From an MDR perspective however, it is the most strictly regulated group of risk class III devices.
The scope for any speculation regarding the qualification of similar devices and their classification into risk classes has been limited by the newly issued MDCG 2022-5. The document does not bring much news or surprising conclusions. However, it explains the context and tries to consistently avoid possible purposive interpretation. For example, while manufacturer claims are still important, it is not possible to classify a product in a category contrary to current scientific data. Manufacturers themselves must always provide scientific justification for the qualification in the technical documentation. For example, a product cannot be qualified as a medical device if it cannot be established that the main intended purpose of the product is achieved by means other than pharmacological, immunological or metabolic. The possibility of using substances which, when used alone, may be considered as a medicinal product but may not have an ancillary effect in a particular situation due to their small amount in the product is also still allowed. These are substances used as flavourings, colourings, antioxidants, etc.
Among the obligations of the manufacturer is the obligation to demonstrate, on the basis of the latest scientific data, whether or not the substance present is ancillary to the main effect of the product. A mere claim by the manufacturer is not sufficient. If he proves that the substance has no additional action in the product, then no benefits related to the substance can be claimed in the instructions for use, labelling, packaging, advertising (including e.g. websites). Appropriate preparation is needed for certification of this type of product.
Author: Aleš Martinovský