Borderline products are health products whose qualification between different regulatory categories is ambiguous due to their nature, composition or presentation. These products do not clearly fall into a single category, making it difficult to determine the regulatory framework applicable to them.
Some examples of borderline products: medicines, medical devices, in vitro diagnostic medical devices (in vitro diagnostics, IVDs), combination products (i.e. a device + a medicinal substance), human body materials, dietary supplements, biocidal products or cosmetics. Determining the correct qualification of these borderline products often requires a detailed analysis of the product's intended clinical use, qualitative and quantitative composition, mechanisms of action (and particularly the principal mechanism of action), and claims.
It is essential to determine the correct qualification of these borderline products at an early stage of their (pre)clinical development, to enable the developers of new health products to identify the regulatory framework to be followed during (pre)clinical development as quickly as possible, and thus facilitate the future marketing of the product for the benefit of patients and health professionals. In this context, the FAMHP's National Innovation Office and Scientific-Technical Advice unit offers innovators the option to request national scientific and/or technical advice (STA: Scientific-Technical Advice) concerning the qualification of these borderline products. This is a centralised and transparent service. It guarantees rapid processing of borderline product qualification requests, while ensuring full confidentiality and avoiding any potential conflict of interest for the experts involved.
In addition, for medical devices and IVD products an advice on the classification of the product can be request through the Borderline STA procedure.
Given that a product in clinical development may still change in composition, function, intended clinical use …, or that studies conducted with the product may provide additional information on the product's mechanism(s) of action, the STAs provided by FAMHP are not legally binding.
Any general or specific inquiries regarding the FAMHP's National Innovation Office and Scientific-Technical Advice unit, concerning borderline products, can be sent to the following email address: sta@fagg-afmps.be.
However, applicants are invited to consult the guidance document (see Regulations) before sending any questions to the above-mentioned email address