Editorial: Substance-based medical devices for human health: a challenge of efficacy, safety, and sustainability

Alessandro Mugelli and Juan Tamargo Treatments without scientific proof of efficacy and safety are offered to and often used by individuals for their medical needs. Substance-based medical devices (SBMDs) are medical devices composed of substances or by combinations of substances as defined in Annex VIII, Rule 21 of the European Medical Device Regulation (MDR) (https://eur-lex.europa.eu/legal-content/ EN/TXT/?uri=CELEX%3A32017R0745). While SBMDs are similar to medicinal products (MPs) in their presentation and pharmaceutical form, they should achieve their therapeutic effect via a “non-pharmacological, immunological, or metabolic mechanism of action.” Independently of the mechanism of action to reach their therapeutic effect, what is of utmost importance is that the therapeutic claim must be demonstrated by well-designed clinical trials and that the benefit/risk ratio reported when SBMDs are marketed should be corroborated by active postmarketing surveillance. Manufacturers must verify the quality and safety of the substances that are in the SBMD according to the EU legislation for patient safety, but this field also represents an opportunity for innovation and research. The new MDR has been in force since May 2021. As clearly reported in the perspective articles by Giovagnoni, “the MDR’s inclusion of different types of product has created a significant opportunity for innovation.” In fact, “the Regulation allowed to repurpose the therapeutic properties of natural complex substances, which were unused, or even considered complementary and alternative medicine, within an evidence-based framework and as part of the healthcare sector.” The aim of this Research Topic is to give the clear message that the healthcare system, the scientific research community, and the industry should be prepared to accept the challenges of this profound regulatory change, transforming this change into opportunities for innovation and health improvement. Interestingly, in the EU, the regulatory changes on clinical research of MPs as well as the more general regulatory framework of medical devices, and in particular of SBMDs, have OPEN ACCESS