The qualification of a substance-based product as a medicinal product or a medical device can be challenging, with several products being “borderline”. In some cases, the product may even be qualified as a cosmetic product.

 

On the European regulatory landscape, this qualification is crucial in order to demonstrate compliance with the appropriate regulation: the Medicinal Product Directive (MPD, Directive 2001/83/EC), the Medical Device Regulation (MDR, Regulation 2017/745) or the Cosmetic Products Regulation (CPR, Regulation 1223/2009).  

 

(Note: In some cases, the product may even be categorized as a biocidal product, in which case the Biocidal Product Regulation (BPR, Regulation 528/2012) applies, but for simplicity, this case is excluded from this article).

 

In this blog post, we provide an overview of the main aspects to take into consideration when classifying a substance-based product, to make sure you are following the right path from the beginning. 

 

 

 

What is a substance-based product? 

 

There is no official definition of a substance-based product. However, the definition of a substance is given in MPD, Directive 2001/83/EC.  

 

Substance: “Any matter irrespective of origin which may be: 

– human, e.g. human blood and human blood products; 

– animal, e.g. micro-organisms, whole animals, parts of organs, animal secretions, toxins, extracts, blood products;

– vegetable, e.g. micro-organisms, plants, parts of plants, vegetable secretions, extracts;  

– chemical, e.g. elements, naturally occurring chemical materials and chemical products obtained by chemical change or synthesis.” 

 

This definition can be simplified into a ‘substance’ means a chemical element and its compounds, while being simple is not very descriptive. 

 

For the purpose of this article, we will define a substance-based product as a product whose action is accomplished by its chemical constituents. These constituents may exist in the solid, liquid, or gas phase, and they may change from one phase to another during changes in temperature or pressure. 

 

Examples of substance-based products include: eye drops, nasal sprays, hyaluronic acid gel for joint injection, among others. 

 

 

Regulatory definitions 

 

In Europe, Directives and Regulations apply to specific product categories, with the said products being defined in the regulations themselves. As introduced above, a substance-based product may be borderline between cosmetics, medicinal products and medical devices. The definitions of these three product categories are provided below. 

 

The CPR (Regulation 1223/2009) defines “cosmetic product” as: 

 

 

The MPD (Directive 2011/83/EC), in turn, provides the definition for “medicinal product”:

 

Finally, the MDR (Regulation 2017/745), defines what a medical device is: 

Interpretation of the definitions

 

First of all, it is clear from the definitions above that a substance-based product may very well be classified as any of the three product categories above, because none of these definitions specifies the form under which a product acts or is used. The key parts of the definitions that can be used to distinguish the different products are underlined above.

 

Cosmetic Product or Medicinal/Medical?

 

The easiest distinction to make is between cosmetic products and medicinal or medical products. In this case, the distinction is made based on the intended use of the product. If the sole purpose of the product is to clean, perfume or affect the appearance of parts of the human body, without providing medical benefits, the product is qualified as a cosmetic product. In case the product bears a medical benefit (in fact, whether or not it is claimed by the manufacturer), the product would then fall either under the medicinal product directive or under the medical device regulation.

 

Medicinal Product or Medical Device?

 

Finally, making the distinction between a medicinal product and a medical device may not be straightforward in some cases because both products are then used for preventing, treating, etc. a medical condition. Here, the distinction between the two types of products is made based on the principal intended mode of action of the device. For products whose actions are accomplished by their chemical constituents (definition of a substance-based product), this means that the qualification of the product depends on the modes of action of its chemical constituents. To qualify such a product, it is therefore needed to evaluate whether the principal intended action of the product is achieved by a pharmacological, immunological or metabolic action. A substance with such mode of action is defined as an active substance by the MPD. Substances without such properties are deemed inactive.

 

In conclusion, whether or not the substance-based product (with a medical purpose) achieves its principal intended use by the action of an active substance determines the application of either the MPD or the MDR. Importantly, a product may have secondary (called ancillary) actions. In the case of a substance-based product, the most probable case is that of a medical device incorporating an active substance. Thus, the product is regulated as a medical device and General Safety and Performance Requirements specific to the active substance (as laid down in Annex I of the MDR) are applicable.

 

Navigating through the definitions and providing the required scientifically-sound rationales for qualifying substance-based products is of prime importance because it may dramatically impact the regulatory pathway (and burden) for market access.

 

Other specific cases

 

Herbal products

 

Herbal medicinal products are considered active ingredients (Article 1 (30) of the MPD), however, historically, for traditional herbal medicinal products, the mechanism of action did not need to be described. Such products were approved for sale based on plausible pharmacological effects or efficacy due to longstanding use and experience.

 

Importantly, if the manufacturer demonstrates that the product’s mode of action is not pharmacological, immunological, or metabolic, these products might qualify as medical devices under the MDR. With that, the MDR provides the possibility for such products which were considered complementary and alternative medicine, to qualify as medical devices within an evidence-based framework.

 

How Medidee can help

 

At Medidee, our expertise includes the support to qualify and classify your substance-based product by reviewing the scientific literature and writing the required classification justification. Medidee also has the experience to provide the necessary documents for fulfilling the additional requirements for substance-based medical devices.

 

Contact us now!

 

This article was written by Dr Cornelia List and Dr Adrien Marchand.