The new article describes in detail the regulatory status of herbal products. 

MDCG

The Medical Device Coordination Group (MDCG), an organization composed of representatives of all Member States and focused on further improvement of the existing legal framework, has published a guidance document dedicated to the borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices.

The document provides an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be taken into consideration by medical device manufacturers and other parties involved in order to ensure compliance. 

At the same time, provisions of the guidance are non-binding in their legal nature, nor are they intended to introduce new rules or impose new obligations, and could also be subject to changes, should such changes be reasonably necessary to reflect corresponding regulatory developments.

Definitions of Herbal Medicinal and Traditional Herbal Medicinal Products

The MDR and MPD distinguish between herbal medicinal products and traditional herbal medicinal products. According to Article 1(30) of the MPD, a herbal medicinal product contains active ingredients that are purely herbal substances or preparations. 

These products may be licensed under various MPD articles, particularly Article 16(a), which allows traditional use provided there is sufficient evidence to support the efficacy and pharmacological effects based on long-standing experience. A traditional herbal medicinal product (Article 1(29), MPD) is a category under which products meet Article 16a(1) requirements, often without fulfilling standard evidence criteria for well-established medicinal use. 

For these products, efficacy is inferred from traditional use. As further explained in the guidance, due to the complex, multi-component nature of many herbal products, defining the principal mode of action can be challenging, especially if the pharmacodynamics are unknown. 

If the primary action of the product is unclear, the product will default to medicinal classification under Article 2(2) of Directive 2004/27/EC.

FDA on assessing credibility of computational modelling2

Legal Framework for Traditional Herbal Products

Directive 2004/24/EC establishes a specific regulatory framework for traditional herbal products, addressing those with a long-standing usage history in the EU but lacking the full scientific validation required for conventional medicinal authorization. In this framework, efficacy is based on traditional usage rather than clinical trials, and these products are recognized as medicinal, provided they meet the necessary conditions.

To standardize the registration and authorization process for herbal medicinal products, EU monographs – official documents prepared by the EMA’s Committee on Herbal Medicinal Products (HMPC) – are available for certain herbal substances. Additionally, the German Commission E, ESCOP, and WHO monographs are used as references. 

Although only HMPC monographs hold legal weight in EU authorization, compliance with these monographs aids in the qualification process for herbal products. The absence of a monograph does not automatically exclude a substance from being classified as a herbal medicinal product, as its primary mode of action must be examined.

Classification Criteria for Herbal Products Under MDR

The MDR allows for products containing herbal substances to be classified as medical devices, provided that the principal mode of action is physical or mechanical, and any medicinal action is merely supportive. For example, a product using herbal components for lubrication or protection without a pharmacological effect may qualify as a medical device.

The authority additionally emphasizes that manufacturers must supply evidence based on scientific research to support the product’s intended action, demonstrating that it does not rely on pharmacological, immunological, or metabolic means as its primary mode of action. In cases where herbal products fit the medical device classification criteria but incorporate herbal ingredients as an ancillary component, the standard MDR classification principles apply.

Examples of Herbal Medicinal Products

The document includes examples of products commonly classified as herbal medicinal products across various EU markets, based on their compositions and claimed therapeutic effects:

  • Cough Syrups: Using ingredients like Icelandic Lichen and Mallow flower, traditionally recognized for antibacterial, anti-inflammatory, and expectorant properties, these syrups aim to relieve throat irritation and cough.
  • Aftersun Ointments: Products containing calendula flower for anti-inflammatory and wound-healing properties are typically used for minor skin inflammations or sunburn.
  • Wound Healing Ointments: Formulated with Echinacea, known for its immunomodulatory and antimicrobial effects, these ointments treat superficial wounds.
  • Intrarectal Ointments for Hemorrhoids: Products with hamamelis bark, an anti-inflammatory, are traditionally used to relieve hemorrhoid-related symptoms.
  • Vaginal Ovules: Formulations with calendula and chamomile extracts provide soothing, lubricating, and protective effects, commonly used for relieving vaginal dryness and irritation.
  • Analgesic Gels: Combinations of herbal extracts like Helichrysum italicum and Arnica montana offer local anesthesia and anti-inflammatory effects, typically for muscle and joint pain.

Each example illustrates products where herbal substances provide the primary medicinal benefit, meeting the traditional use criteria required for herbal medicinal product classification.

Conclusion

In summary, the document explains that herbal medicinal products hold a distinct place under the EU regulatory framework, supported by traditional usage evidence and specific herbal monographs for standardization. However, herbal products may still be classified as medical devices when their principal intended action is non-pharmacological, relying on physical means. The guidance emphasizes the need for manufacturers to provide scientific data substantiating the primary action of herbal substances in each product, ensuring accurate classification under MDR or MPD.

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