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CC BY-NC-ND 4.0 · Planta Med 2021; 87(12/13): 1110-1116
DOI: 10.1055/a-1511-8558
Formulation and Delivery Systems of Natural Products
Reviews

Medical Devices Made of Substances: Possible Innovation and Opportunities for Complex Natural Products[ # ]

Anna Rita Bilia
1   Department of Chemistry “Ugo Schiff,” University of Florence, Sesto Fiorentino, Florence, Italy
,
Enrico Stefano Corazziari
2   IRCCS Humanitas Research Hospital, Department of Gastroenterology, Rozzano, Milan, Italy
,
Stefano Govoni
3   Department of Drug Sciences, University of Pavia, Pavia, Italy
,
Alessandro Mugelli
4   Department of Neurosciences, Psychology, Drug Research and Child Health, Section of Pharmacology and Toxicology, University of Florence, Florence, Italy
,
Marco Racchi
3   Department of Drug Sciences, University of Pavia, Pavia, Italy
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Abstract

The novel Regulation 2017/745/EC on medical devices introduces and strengthens the role of “medical devices made of substances”, which mostly include substances of natural origin. Natural products may follow different regulations, from food to therapeutics. Concerning their isolated constituents, extracts are characterized by a complexity that is not easily tackled from both a scientific and a regulatory point of view, but more importantly, from a therapeutic point of view. The evidence-based approach applied to isolated molecules requires appropriate evidence of quality, efficacy, and safety. The same needs must be reached for complex substances by finding appropriate methods to generate this evidence, and in addition, defining an appropriate regulatory field for them. From a scientific point of view, new methods, such as those proposed by systems biology, are available and applicable to complex substances. From a regulatory point of view, Directive 2001/83/EC on medicinal products seems to be modeled on single (or combinations of single) molecule products. On the other hand, Regulation 2017/745/EC on medical devices seems to apply to complex substances without derogating on quality, efficacy, and safety. The regulation specifically names and strengthens medical devices that include substances, mostly of natural origin, introducing the official term “medical devices made of substances”. This paper discusses and proposes an interpretation of important terms connected to this legislation, regarding both scientific and regulatory issues, and the opportunities the regulation may give for innovation and therapeutic improvement with natural complex substances.

Key words

herbal medicinal products - medical devices - medical devices made of substances - Regulation 2017/745/EC - systems biology - pharmacological action

# Dedicated to Professor Arnold Vlietinck on the occasion of his 80th birthday.




Publication History

Received: 28 October 2020

Accepted after revision: 13 May 2021

Article published online:
06 August 2021

© 2021. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commecial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/)

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