Natural product research at the crossroad: experimental and clinical approaches in light of the new Regulation on Medical devices (Reg 2017/745/CE), which specifically addresses medical devices made of substances

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Background

The Medical Device (MD) Regulation EU 2017/745, entered into force on May 26, 2021, provided a
completely new regulatory scenario for MD and established a more robust legislative framework at
guarantee of the safety and efficacy of therapeutic options accessing the market.
One of the main changes that will affect the MD regulatory field is the presence of a specific classification rule (Rule 21), for medical devices made of substances. This rule refers to medical devices made of substances or combinations of substances, whether natural or synthetic, that are intended to be introduced into the human body through a body orifice or applied to the skin and that are absorbed by or locally dispersed into the human body.

The main pillar upon which medical devices differ from medicinal products relies in their mechanism of
action whose demonstration has important regulatory implications. MD and medicinal products both serve to treat, alleviate or prevent a disease but, in the case of MD, as opposed to medicinal products, the principal mechanism of action trough which they achieve their effect is non- pharmacological, non-
immunological and non-metabolic. Natural substances and combination of natural substances are complex mixtures of a great variety of molecules that often do not act in a single, targeted way, that is the prerogative of medicinal products, rather can exert multiple effects by acting in a synergistic way.

Moving from a single substance to a complex mixture of substances as the case of natural products, the
demonstration of a non-pharmacological, non-immunological and non-metabolic mechanism of action is challenging and stimulating for researchers. Experimental protocols and clinical investigation should be correctly designed and optimized according to the mechanisms to be demonstrated or excluded and according to the complex and multiple biological pathways that may be affected by complex mixtures of substances. The theory and methods of system biology including genomics, epigenomics, proteomics and metabolomics and their potential applications in the field of Substance- based MD research and development should be also discussed.

The goal of this Research Topic is to focus on research approaches aimed at evaluating the effects of
natural complex substances, the underlying mechanisms of action and potential toxicity of the product
under evaluation.

This Research Topic aims to solicit experimental studies on the effects and mechanism of action of
substances and combination of substances in light of the MD regulation. In addition, the design and
implementation of clinical trials aimed at evaluating the efficacy and safety of such products are welcome. Original Research, Clinical studies, Reviews, Perspectives and Opinions are welcome.

Keywords: Substance based Medical devices, Medical device regulation, mechanism of action, system biology, safety

Important note: All contributions to this Research Topic must be within the scope of the section and journal to which they are submitted, as defined in their mission statements. Frontiers reserves the right to guide an out-of-scope manuscript to a more suitable section or journal at any stage of peer review.

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