CRED ERP 25

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5. Borderline products and combination products

When considering these types of products, one must consider which group the product falls into: • Medical Device • Cosmetic • Other – food supplements, other cosmetic products.

In order to make this decision, ask the following questions: • Does it meet the definition of a medicine? • What claims are made? • How is it presented? • How does it work?

Is it a Medicinal Product or Medical Device? Medicinal product: (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. Software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of: o Diagnosis, prevention, monitoring, treatment or alleviation of disease o Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap, o Investigation, replacement or modification of the anatomy or of a physiological process, o Control of conception, o and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means. Medical Device means any instrument, apparatus, appliance: •