MDCG 2022-5 states: “A product containing a herbal substance is not automatically a medicinal product or a traditional herbal medicinal product.” The assessment requires two questions.
The first concerns the product as a whole. A substance-based medical device is composed of permitted substances and does not achieve its principal intended action by pharmacological, metabolic or immunological means. A product with a substance of plant origin should be qualified as a medical device if that substance achieves its principal intended action by other means and the product fits Article 2(1) MDR.
The second concerns the role of the herbal constituent. Even where herbal substance(s) and/or herbal preparation(s) have a demonstrated pharmacological action, the product could remain a medical device if that action is only ancillary and the principal intended action of the product is achieved by physical or mechanical means. If the herbal substance would, when used separately, be considered a medicinal product, its inclusion may lead to class III under Rule 14.
The distinction requires evidence. MDCG states, that manufacturers should provide solid state of the art scientific data to demonstrate the principal mode of action.
This can be difficult because herbal medicinal products are usually multicomponent mixtures. If pharmacodynamics are unknown, the principal mode of action may be difficult to define. Where it remains unclear which substance is responsible for the principal intended action – or whether that action is pharmacological, immunological or metabolic – the product will be considered a medicinal product.
Starodub experts can help you navigate this regulatory uncertainty and assess the appropriate regulatory pathway for your product. Contact us at info@starodub.nl to discuss your case.
