Medical Devices Made of Substances: The Need for a Change in Approach in Paediatrics

Stagi, Stefano

doi:10.3389/fdsfr.2022.867143

Cited by 2 publications

(1 citation statement)

References 33 publications

(46 reference statements)

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“…Several chronic, multifactorial disorders with unsatisfying medical treatment can benefit from MDMS regulation; this is the case of treatment of some gastrointestinal illness (Corazziari, 2020;Bilia et al, 2021) or metabolic disorders (Guarino et al, 2021), even in the pediatric population (Strisciuglio et al, 2021;Stagi, 2022). In this scenario, MDR provides opportunities for therapeutic innovation with complex substances while guaranteeing patients with standards of efficacy and safety.…”

Section: Conclusion and Open Questionsmentioning

confidence: 99%

New regulation on medical devices made of substances: Opportunities and challenges for pharmacological and toxicological research

Fimognari

Barrajón‐Catalán

Luceri

et al. 2022

Front. Drug Saf. Regul.

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The Medical Device (MD) Regulation EU 2017/745 (MDR) has provided a completely new and more robust regulatory framework at guarantee of the safety and efficacy of therapeutic options accessing the market. At the same time, the MDR poses several challenges for stakeholders, among which, the most significant lying on MDs made of substances (MDMS) whose mechanism of action should be non-pharmacological, immunological, or metabolic.Moving from single active substances to very complex mixtures, such as the case of natural products, the demonstration of the non-targeted, non-pharmacological mechanism, is even much more challenging since it is very hard to specifically identify and characterize all the interactions each constituent can have within the body.New scientific paradigms to investigate these multiple interactions and delineate the principal mechanism of action through which the effect is achieved are necessary for the correct regulatory classification and placement in the market of MDMS.This article will discuss the difficulties in delineating the boundaries between pharmacological and non-pharmacological mechanisms, practical approaches to the study of complex mixtures and the challenges on the application of current experimental paradigms to the study of the mechanism of action of MDMS.

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Section: Conclusion and Open Questionsmentioning

confidence: 99%

New regulation on medical devices made of substances: Opportunities and challenges for pharmacological and toxicological research

Fimognari

Barrajón‐Catalán

Luceri

et al. 2022

Front. Drug Saf. Regul.

View full text Add to dashboard Cite

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European Union Regulation on clinical trials and Regulation on medical devices: A common soil for future development

Rasi

Alessandro

2022

Front. Drug Saf. Regul.

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The recent European Union (EU) Regulations on clinical trial on medicinal products (MPs) (2014/536) and on medical devices (MD) (2017/745) represent potential improvement for the European health system and may offer advantages to the citizens. As Regulations, they are immediately applicable in Member States overruling national laws, being an advantage for stakeholders (e.g. sponsors and investigators) and Europe becomes de facto one homogeneous place for research and development of medicines and medical devices. This perspective commentary focuses on the most relevant methodological and regulatory aspects of the recent Regulation on clinical trials for drug development and how it may indirectly impact on substance-based medical devices (SBMD). The article highlights the innovations associated with the 2017/745 Regulation, especially to the area of SBMD, which represent a novelty among MDs. Since SBMDs share some aspects of medicines, they will increasingly undergo research in the future related to the performance and safety claims, via post-marketing surveillance. Importantly, SBMD’s Consumers are rapidly increasing due to their usage to treat some common symptoms, which not necessarily need conventional medicines. “Frontiers in Drug Safety and Regulation” created a section to reflect this rapidly-changing scenario and host reports on SBMD in a scientific environment. This initiative is also a reflection of the recent regulation on SBMDs. Thus, the improvement of clinical research through the new EU Regulation on clinical trials may become useful also to the new requirements for SBMD. A novel editorial initiative will further contribute to implement the EU Regulation providing adequate scientific dissemination.

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Medical Devices Made of Substances: The Need for a Change in Approach in Paediatrics

Cited by 2 publications

References 33 publications

New regulation on medical devices made of substances: Opportunities and challenges for pharmacological and toxicological research

New regulation on medical devices made of substances: Opportunities and challenges for pharmacological and toxicological research

European Union Regulation on clinical trials and Regulation on medical devices: A common soil for future development

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