According to Article 2(1) of the MDR, a medical device does not achieve its principal intended action by pharmacological, immunological, or metabolic means in or on the human body but may be assisted in its function by such means. Notably, as per MDCG 2022-5, the concept that a medical device may be assisted in achieving its principal intended action by these means covers cases where the device incorporates, as an integral part, a medicinal substance with an ancillary action to that of the device. Such medical devices are covered by Rule 14 of the MDR. If the principal intended action of the device is mainly achieved by the action of this medicinal substance, this integral product shall be regulated as a medicinal product.
Another category of medical devices covered by the MDR is substance-based medical devices. These are medical devices composed of substances that do not achieve their principal intended action by pharmacological, metabolic, or immunological means. Under the MDR, there are two classification rules specific to substance-based devices – Rule 3 and Rule 21.
It is important to note that there may be ancillary pharmacological, metabolic or immunological action of one or more of the substance(s) the device is made of. Thus, if the principal intended action of such substance-based medical devices is supported by these means, Rule 14 must be applied. It is then considered as a device that incorporates, as an integral part, an ancillary medicinal substance.
If the principal intended action of the device is mainly achieved by the action of this medicinal substance, this product shall be regulated as a medicinal product.
Exceptions are possible. If it can be demonstrated that a substance is not available to the human body or its constituents, for example, because it is fixed in the matrix of the device without leaching or surface interaction with the body or its constituents, it is considered not to have an ancillary action. Similarly, if the manufacturer demonstrates that the substance is present in such a quantity that it does not have an action in or on the human body or its constituents, it is deemed not to have an ancillary action.
Examples of such substances that, if used separately, could be considered medicinal products and may be available to the human body or its constituents but might not have an ancillary action due to the quantity available, include substances like flavorings, colorants, antioxidants, or chelating agents. This is provided they do not have any other type of action in or on the human body or its constituents that is ancillary to the device after being administered. If the manufacturer shows that the substance does not have any ancillary action to that of the device, no claims of benefits related to that substance may be made on the IFU, labelling, packaging, etc.
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