In January, the European Court of Justice (ECJ) published a new judgement on the medicine/medical device borderline issue: L. GmbH and H. Ltd v Bundesrepublik Deutschland. It is hoped that the ruling will provide some clarity for manufacturers attempting to navigate this tricky area of law.
Borderline products
Drug/device borderline products are those which straddle the line between being a medical device and a medicinal product. For example, a bandage which is coated in menthol to help with pain relief appears to have features of both a medical device (i.e. the compression bandage aspect) and a medicinal product (i.e. the menthol cooling aspect). This overlap creates problems from a regulatory perspective as it is not always clear which set of laws should apply.
Under the EU regulatory framework, a product can only qualify as a medicine or a medical device, it cannot be both. The Medical Device Regulations contain certain rules designed to separate out these two product categories. For example, the definition of a medical device explicitly excludes products which act primarily by pharmacological, immunological or metabolic means.[1] Returning to the example of a menthol coated bandage, this would therefore qualify as a medicine since the primary action of the product is to deliver menthol which provides pain relief through pharmacological means.
The ECJ ruling
In its January 2023 judgement, the ECJ was asked to rule on several drug/device borderline questions referred to it by the German Federal Administrative Court in relation to two separate cases concerning nasal sprays and nasal drops respectively. In particular, the German court asked the ECJ to provide guidance on what to do in cases where it is not clear (based on current scientific knowledge) whether the principal action of a product is pharmacological, immunological or metabolic.
In its judgement the ECJ noted that, in the absence of scientific evidence establishing the principal mode of action, a product cannot qualify as a medical device. The court justified this finding on the grounds that the definition of a medical device creates a specific requirement for manufacturers to provide proof that the principal mode of action of their product is not pharmacological, immunological or metabolic. If manufacturers do not know what the principal mode of action is, then they cannot definitively prove that it is not pharmacological, immunological or metabolic.
On the other hand, the ECJ also noted that products without an established principal mode of action will fail to meet the functional limb of the medicine definition (which requires that the product treats/prevents diseases by exerting a pharmacological, immunological or metabolic action).[2] However, the medicine definition also contains a presentational limb whereby goods which don’t function as medicinal products may still qualify as such based on their presentation. The court noted that products which are presented to consumers as being able to treat/prevent diseases will qualify as medicines, even where their primary mode of action is not clear.
Considering the application of this to the German cases, the ECJ stated that any assessment of a product's presentation requires an examination of its labels, leaflets and oral representations to determine whether the averagely well informed consumer would consider it a medicinal product. Ultimately, as the ECJ emphasised, this is an issue for the national authorities to consider on a case-by-case basis.
How we can help
Regtik, our healthcare regulatory explorer tool, can help you navigate the legal maze by walking your product through a series of simple questions designed to determine whether it qualifies as a medical device or a medicine. It is able to provide results for various jurisdictions (the US, EU, UK and Australia) in one single assessment and can be used multiple times on different versions of your product.
If you are interested in learning more about Regtik or would like to request a demo, please contact any member of our team or register your interest below.
[1] Regulation 2017/745, Article 2(1) and Directive 93/42/EEC, Article 1(2)
[2] Directive 2001/83/EC, Article 1(2)