The European Court of Justice clarifies different definitions of a medicinal product and a medical device

In a recent judgment in response to a request for a preliminary ruling (CURIA - List of results) the European Court of Justice (ECJ) provided guidance concerning how to distinguish medicinal products from medical devices. The referring court in the matter asked whether Article 1(2)(b) of Directive 2001/83 must be interpreted as meaning that a substance which, by means of a reversible binding to bacteria, prevents the bacteria from adhering to human cells, must be regarded as exerting a "pharmacological action" as defined in that provision.

Referring to MDCG 2022 – 5 Rev. 1 Guidance, the Court recalled that the term "pharmacological means" is to be understood as an interaction typically at a molecular level between a substance or its metabolites and a constituent of the human body which results in initiation, enhancement, reduction or blockade of physiological functions or pathological processes.

The Court concluded that a substance which, by means of a reversible binding to bacteria, prevents the bacteria from adhering to human cells must be regarded as exerting a "pharmacological action" within the meaning of Article 1(2)(b) of Directive 2001/83.

Consequently, a product that falls within the definition of a "medicinal product" provided in Article 1(2)(a) or (b) of Directive 2001/83, is covered by the legal regime established by that Directive. It may not, therefore, be classified as a "medical device" within the meaning of Directive 93/42/EEC, which has been replaced and expanded by Article 2(1) of Regulation 2017/745.