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.

中文翻译：

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由物质制成的医疗器械：复杂天然产品的可能创新和机遇

关于医疗器械的新法规 2017/745/EC 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。天然产品可能遵循不同的规定，从食品到疗法。关于它们分离的成分，提取物的特点是复杂，从科学和监管的角度来看都不容易解决，但更重要的是，从治疗的角度来看。应用于分离分子的循证方法需要质量、功效和安全性的适当证据。必须通过寻找适当的方法来生成这些证据来满足复杂物质的相同需求，此外，还必须为其定义适当的监管领域。从科学的角度，新的方法，例如系统生物学提出的那些，可用于复杂物质。从监管的角度来看，关于医药产品的指令 2001/83/EC 似乎是以单一（或单一）分子产品的组合为模型的。另一方面，关于医疗器械的法规 2017/745/EC 似乎适用于复杂物质，而不会减损质量、功效和安全性。该法规特别命名和加强了包含物质的医疗器械，这些物质主要来自天然，引入了官方术语“由物质制成的医疗器械”。本文讨论并提出了对与该立法相关的重要术语的解释，涉及科学和监管问题，以及该法规可能为天然复合物质的创新和治疗改进带来的机会。