EU Borderline Products

The status of many products on the “borderline” between medicinal products and food supplements, biocides, cosmetic products or medical devices can be difficult to determine.

These cases are decided after considering the manufacturer’s intended purpose for the product taking into account the way it is presented and the method by which the principal mode of action is achieved. In the case of a medical device, the principal mode of action is typically fulfilled by physical means (including mechanical action, physical barrier, replacement of, or support to, organs or body functions).

Medical devices may be assisted in their function by pharmacological, immunological or metabolic means as long as this is not defined as their principal mode of action. Accordingly, where a product achieves its principal intended action by pharmacological, immunological or metabolic means, it is a medicinal product.

According to MDR (classification Rule 14) All devices incorporating, as an integral part, a substance which, if used separately, can be considered to be a medicinal product, as defined in point 2 of Article 1 of Directive 2001/83/EC, including a medicinal product derived from human blood or human plasma, as defined in point 10 of Article 1 of that Directive, and that has an action ancillary to that of the devices, are classified as class III.

See our blog about the Borderline Products Classification in EU here.

Our experts can help you to classify your product, build the most viable regulatory strategy and bring the product to the market.

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