Department of Chemistry "Ugo Schiff," University of Florence, Sesto Fiorentino, Florence, Italy.
IRCCS Humanitas Research Hospital, Department of Gastroenterology, Rozzano, Milan, Italy.
Planta Med. 2021 Oct;87(12-13):1110-1116. doi: 10.1055/a-1511-8558. Epub 2021 Aug 6.
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.
2017/745/EC 号医疗器械新法规引入并加强了“由物质制成的医疗器械”的作用，其中主要包括天然来源的物质。天然产物可能遵循不同的法规，从食品到治疗药物。关于其分离的成分，提取物的特点是其复杂性，从科学和监管的角度来看，更重要的是从治疗的角度来看，都难以解决。应用于分离分子的循证方法需要适当的质量、疗效和安全性证据。对于复杂物质，必须通过找到生成这些证据的适当方法，并为它们定义适当的监管领域来达到同样的要求。从科学的角度来看，新的方法，如系统生物学提出的方法，是可用的并且适用于复杂物质。从监管的角度来看，2001/83/EC 号关于药品的指令似乎是以单一（或单一组合）分子产品为模型。另一方面，2017/745/EC 号医疗器械法规似乎适用于复杂物质，而不会在质量、疗效和安全性上有所减损。该法规特别提到并加强了包含物质的医疗器械，这些物质主要来自天然来源，引入了“由物质制成的医疗器械”的正式术语。本文讨论并提出了对与该法规相关的重要术语的解释，包括科学和监管问题，以及该法规可能为创新和治疗用天然复杂物质带来的机会。
