Christian Micheletti*, Federico Benetti
*Corresponding author
ECSIN, ECAMRICERT
Viale Porta Adige 45,
45100 Rovigo (RO), Italy

Abstract

Extracts from plants, also called “botanicals”, are extensively used due to their health and functional properties. Botanicals are mostly used in phytotherapy and nutraceuticals, but a recent market trend shows their use in medical devices. The regulatory framework of this kind of products is borderline between Medical Devices and Medicinal Products. The recent proposal for a European Medical Devices Regulation is giving some clarity about how safety and efficacy of innovative medical devices based on substances is approached by regulators. The Regulation proposal is also addressing innovation through nanotechnology, which is used by small and medium companies to gain a competitive edge in a very competitive market. This opinion discusses the Regulation proposal prescriptions implications for the companies.

BACKGROUND

The market of products based on substances and classified as medical devices (MDs) is growing. Usually they are self-care products with one or more substances for applications ranging from nose cleaner to cough syrups, including creams to support treatment of skin irritation and skeletomotor dysfunctions (e.g. muscle soreness). The variety of composition and commercial form of medical devices based on substances is significant, and it includes products for oral use, similar to food supplements and often based on extracts from plants (botanicals). To increase stability, bioavailability, and targeting of the substances, not so differently from nanomedicine and nutraceuticals, nanotechnology is sometimes used to develop more effective formulations, with innovation as a marketing upside of the product. The choice to place on the market a new product as food supplement or medical device is made by companies on the basis of strategic interest for specific target users or product visibility. Being the two sectors regulated by different legislations, the choice has consequences in terms of regulatory requirements. According to the Novel Food Regulatio ...