ABSTRACT
Article 1(2) MPD defines a medicinal product as follows: (a) Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or (b) Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis. This definition comprises two limbs, one relating to presentation and the other to function. A product constitutes a medicinal product if it is covered by one or other or both of those limbs. The definition of a medicinal product is applied on a case by case basis and determination takes into account current European Case Law. The Medicinal Products Directive (MPD), Article 2(2), is clear that, in cases of doubt, taking into account all of a product’s
characteristics, if a product meets both the definition of a medical device and a medicinal product, then the MPD will apply. 23.1.1.3 Combination products: Principal mode of actionThe principal intended action of a combination product is deter-mined based on the mechanism of action of the device and medicinal substance aspects. The manufacturer’s labelling and claims are also taken into account, but they should be in line with, and not contradict, current scientific data. The product manufacturer should be able to justify scientifically their rationale for the design and classification of the combination product. Useful definitions from MEDDEV 2.1/3“Pharmacological means” is understood as an interaction between the molecules of the substance in question and a cellular constituent, usually referred to as a receptor, which either results in a direct response, or which blocks the response to another agent. Although not a completely reliable criterion, the presence of a dose-response correlation is indicative of a pharmacological effect. “Immunological means” is understood as an action in or on the body by stimulation and/or mobilisation of cells and/or products involved in a specific immune reaction. “Metabolic means” is understood as an action which involves an alteration, including stopping, starting or changing the speed of the normal chemical processes participating in, and available for, normal body function. Medical devices may be assisted in their function by phar-macological, immunological or metabolic means, but as soon as these means are not ancillary with respect to the principal intended action of a product, the product no longer fulfils the definition of a medical device and the product will be regarded as a medicinal product. ExamplesBone cements and gentamicin-loaded polymethylmethacrylate (PMMA) beads are useful examples of combination products for illustration of the classification rules: • Plain bone cement without antibiotics is a medical device
since it achieves its principal intended action (the fixation of prosthesis) by physical means.
