Regulation 2017/745 on medical devices, two major innovations: 1) the physiological action of devices consisting of natural materials such as vegetal matrices; 2) the chemical-physical-mechanical action of devices made of “substances”, which as such are artificial derivatives

Marcella Marletta
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Abstract

The Medical Device Regulation 2017/745 (MDR) enables the development of a wide range of innovative products. With respect to Directive 93/42, the MDR explicitly identifies the so-called “medical devices made of substances” (MDMS) through specific requirements. In addition, the MDR expands the definition of medical device (MD) by including the “modification of a physiological or pathological state” as a medical purpose specific to devices. This clarifies that materials interacting with the human body in such a way as to modify its “state” are medical devices. Natural materials, such as vegetal matrices, are characterized by the presence of both functional and structural interactions between their components; they can thus be described as “network/s" and interact with the human body in a coordinated, complex way. Since the “state” of the human body is a network of biological functions, the “network/s over a network” interaction between the natural material and the human body is likely to modify the “state” of the human body. Thus, therapeutic products consisting of natural materials, such as vegetal matrices, seem to fit perfectly into the definition of a medical device. Here we analyze the main characteristics of medicinal products, of medical devices made of substances and of medical devices consisting of natural materials. We see that medicinal products and medical devices made of substances have the common characteristic of being based on substances, either synthetic or derivatives of natural materials, but differ in their mechanism of action. On the other hand, medical devices constituted of natural materials relate to the general category of medical devices and cannot be characterized by any single component, identified as an active component. We also discuss how these characteristics relate to the mechanism of action of each type of product. This analysis should allow to identify the most appropriate path for each product, a necessary step to promote research and development of innovative therapies for a large number of unmet medical needs.
关于医疗器械的第 2017/745 号法规有两大创新:1) 由天然材料(如植物基质)构成的器械的生理作用;2) 由 "物质 "构成的器械的化学-物理-机械作用,而 "物质 "本身就是人工衍生物
医疗器械法规 2017/745(MDR)促进了各种创新产品的开发。与第 93/42 号指令相比,MDR 通过具体要求明确识别了所谓的 "由物质制成的医疗器械"(MDMS)。此外,MDR 还扩展了医疗器械 (MD) 的定义,将 "改变生理或病理状态 "作为医疗器械的特定用途。这就明确了与人体相互作用以改变其 "状态 "的材料属于医疗器械。天然材料(如植物基质)的特点是其组成部分之间既有功能上的相互作用,也有结构上的相互作用;因此,它们可以被描述为 "网络",并以协调、复杂的方式与人体相互作用。由于人体的 "状态 "是一个生物功能网络,天然材料与人体之间的 "网络/网络 "相互作用很可能会改变人体的 "状态"。因此,由天然材料(如植物基质)组成的治疗产品似乎完全符合医疗器械的定义。在此,我们分析一下医药产品、由物质构成的医疗器械和由天然材料构成的医疗器械的主要特点。我们看到,医药产品和物质医疗器械的共同特点是以物质为基础,这些物质可以是人工合成的,也可以是天然材料的衍生物,但在作用机理上有所不同。另一方面,由天然材料构成的医疗器械属于医疗器械的一般类别,不能以任何单一成分作为活性成分。我们还讨论了这些特征与各类产品作用机制的关系。这种分析应有助于为每种产品确定最合适的途径,这是促进研究和开发创新疗法以满足大量未得到满足的医疗需求的必要步骤。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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