Borderline Products in the EU: Obstacles for Manufacturers and Importers


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In order to be compliant with the regulatory requirements for a specific product in the EU market, one crucial preliminary step is to identify and categorise a given product and determine to which regulatory framework it belongs. This can be a quite challenging task since there are products that lie between two categories consequently being affected by different regulatory frameworks. The term borderline product is used when a product lies on the edge of one product category and verges on another. Criteria which can lead to a product being regarded a borderline product are for example, its purpose (or intended use) and its function, in case they overlap with those of other product categories.

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