New EU judgment on the classification of borderline products

The Court states that where the principal mode of action of a product has not been scientifically established, the product can be considered neither a "medical device" nor a "medicinal product by function". This means that when it isn't clear whether the expected principal action of a product is pharmacological, immunological or metabolic, the product is neither a medical device nor a medicinal product.

Furthermore, the Court states that if a product is considered to be a "medicinal product by designation", the product must not also be considered to be a "medical device". 

A product is regarded as a "medicinal product by presentation" when the product is presented by the manufacturer as a medicinal product, including, for example, when the product is explicitly described or recommended as a medicinal product, for example by the means of labels, instructions for use or other marketing elements. A product will also be regarded as a "medicinal product by presentation" if the product appears to be a medicinal product to a reasonable average consumer. 

The Court states that factors such as the presentation of the product concerned as having properties for treating or alleviating disease, references to medicinal interactions and adverse effects, and pharmacy-only distribution, are factors which, taken as a whole, are capable of making the products concerned appear to an averagely well-informed consumer to have the properties of a medicinal product. 

It is up to the national courts to assess in each case whether the conditions relating to the definition of a "medicinal product by designation" are fulfilled. 

Read the decision

Want to know more?

If you want to know more about the rules for classifying products as medicinal products and medical devices, please contact Plesner's Life Science team.