Substance-based medical device or medicinal product:
Definition, demarcation and current case law
Introduction
The distinction between medical device and medicinal product has become increasingly difficult with the MDR, especially for substance-based medical devices. In addition, the far-reaching impact of the current ECJ case-law poses additional regulatory challenges for manufacturers of such products, which makes precise classification of these products indispensable.
Definition and Examples of substance-based Medical Devices
Substance-based medical devices consist of substances or a combination of substances and often resemble pharmaceuticals in their presentation and dosage form, but are medical devices. According to the “Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices” (MDCG 2022 – 5), substance-based medical devices are those that:
- Are composed of substances that are permitted in a medical device, and
- do not achieve its principal intended action by pharmacological, metabolic or immunological means
Substance-based medical devices achieve their purpose by physical and/or mechanical mechanisms of action, such as the formation of a physical barrier, hydration or dehydration, and a change in the pH-value. This demarcation is critical to the regulatory status of a product.
Typical examples of medical products include:
- Salty nasal drops or sprays
- Slime-forming linctus, throat spray or lozenge
- Artificial tears
- Vaginal creams or gels to restore the physiological environment
- Osmotic laxatives
The demarcation from medicinal products
Medicinal Product by Function vs. Medicinal Product by Presentation
In Article 1, the Medicinal Products Directive 2001/83/EC distinguishes between two scenarios which, by definition, make a product a medicinal product which are generally, but expressly not in the Directive, as so-called ‘medicinal product by presentation’ (Art. 1 No. 2 letter a) or “medicinal products by function” (Art. 1 No. 2 letter b).
Medicinal product by presentation
In accordance with Article 1 No. 2(a) of Directive 2001/83/EC all substances or compositions of substances intended as means of properties for curing or preventing human disease are “medicinal product by presentation".
A product is considered a medicinal product by presentation if:
- specifically designated or recommended as a means of properties for the cure, relief or prevention of diseases, or
- in the case of an averagely informed consumer, even conclusively, but certainly gives the impression that, in view of its presentation, it must have corresponding characteristics.
The term "determination" must be interpreted broadly according to the case law of the ECJ.
Medicinal Product by Function
Medicinal products by function are referred to in Article 1 No. 2(b) of Directive 2001/83/EC "all substances or compositions which may be used in or on the human body or administered to a human body in order to either restore, correct or influence human physiological functions through a pharmacological, immunological or metabolic effect or to make a medical diagnosis".
Medicinal products by function actively influence physiological functions through their effect. The classification as a medicinal product by function requires that the pharmacological, immunological or metabolic effect of the product is scientifically proven.
Significant differences in regulatory classification
The distinction between substance-based medical devices and medicinal products has significant regulatory and economic consequences:
- Authorisation procedure: Medicinal products require a drug approval in accordance with § 21 para. 1 AMG, while for medical devices different conformity assessment procedures apply depending on the classification.
- Clinical trials: Medicinal products usually require more extensive and costly clinical studies, which are usually in the 3-digit million amount (out-of-pocket cost) for novel active substances. This is usually not the case with medical devices. Exceptions to this may occur in Class III high-risk products.
- Advertising possibilities: For medical devices, a less stringent regulation of the promotion of the products applies, for example with regard to the mandatory information, the prohibitions of certain advertising content and restrictions on disease advertising.
Groundbreaking ECJ ruling of 19. January 2023
In January 2023, the European Court of Justice delivered an important judgment in Joined Cases C-495/21 and C 496/21 on the demarcation between medical devices and medicinal products. The Court states the following key principles:
Lack of scientific evidence: ‘In the absence of scientific evidence, [...] that the intended main effect in or on the human body is not achieved by pharmacological or immunological agents or metabolic means, a product cannot be classified as a ‘medical product’.’
Role of national courts: In the absence of scientific knowledge of the mechanism of the intended main effect, ‘it is a matter for the national courts to assess in individual cases whether the conditions for the definition of ‘medicinal products by presentation’ within the meaning [of Article 1 No. 2(a] of Directive 2001/83 are fulfilled.’;
DThe ECJ therefore judges in summary as follows: If the main mode of action of a product cannot be determined scientifically, it does not fall into the category of medical devices nor in the category of “medicinal product by function”. Instead, it must be checked whether it is to be classified as a “medicinal product by presentation”.
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Impact for manufacturers
This case law poses new challenges to manufacturers of substance-based medical devices. Although the Medical Device Regulation had explicitly recognised the status of these products by Rules 21 and 3, the new case law could now deny many existing products the status as a medical device.
The situation is particularly critical for products with herbal ingredients, whose mechanism of action is often complex and scientifically not always fully clarified. Important information can be found in the already mentioned MDCG 2022-5 document.
Solutions and Strategies for Manufacturers
Despite the regulatory challenges, there are several strategies that enable manufacturers to protect the status of their products as medical devices:
- Scientific evidence of the mechanism of action
For substance-based medical devices, it is crucial to create a solid scientific documentation that clearly demonstrates that the primary mechanism of action is physical or chemical and not pharmacological, immunological or metabolic. - Management of herbal ingredients
For products with plant preparations or extracts, it should be demonstrated on the basis of current scientific findings that the plant ingredients have a predominantly physical effect, taking into account composition, preparation, dosage and indication. A first approach can be comparison with any EU monographs. - Evaluation of auxiliary substances
Manufacturers can scientifically demonstrate that these substances, because of their small quantity, have no supporting effect within the meaning of the intended purpose and should therefore not lead to classification as medicinal products or to upgrade to Class III medical products. The MDCG 2022-5 offers a starting point for flavourings, colourings, fragrances and preservatives. - Check product presentation
In order to avoid classification as a “medicinal product by presentation”, manufacturers should carefully review the presentation of their products, including labelling, instructions for use and marketing and ensure that they do not give the impression of having drug properties.
Outlook: Developments in the EU
In April 2023, the European Commission presented a proposal for a new mechanism for the classification of border products as part of the comprehensive reform of the European pharmaceutical legislation (EU pharmaceutical package). This should help to clarify at an early stage in the development process whether a product is to be classified as a drug or as a medical device.
Conclusion
The distinction between substance-based medical devices and pharmaceuticals remains a complex field that has retained additional complexity through the January 2023 ECJ ruling. The decision clarifies that without a scientifically established main mode of action, a product cannot be classified as a medical device.
For manufacturers of substance-based medical devices, it is more important than ever to prove the mechanism of action of their products in a scientifically sound manner and to critically examine their product presentation in order to protect the status as a medical device.
Since the decision on the classification of a product in individual cases must be taken taking into account all relevant factors, it is advisable for manufacturers to act proactively and to review and update the scientific documentation of their products at an early stage.
The planned introduction of a new EU mechanism for the classification of border products could bring more clarity in the future and help manufacturers to identify and minimise regulatory risks at an early stage. Manufacturers must assume that the concept of ‘pharmacological effect’ will certainly be broader rather than narrower in the future, as is already the case in the judgment of 13. 3. 2025 was the case in Case C-589/23
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