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

Abstract

Paediatricians are often called on to weigh up potential side effects and interferences associated with drug treatments. Ethical concerns often prevent clinical trials in children, meaning that specific data for the paediatric population can be lacking. This is true for pharmacological therapies and also natural remedies used as add-on therapy. Among natural health products are “medical devices made of substances” (MDMS) which have become increasingly important in the treatment of many disorders; the substances contained in MDMSs frequently consist of molecular structures present in a standardized preparation derived from a natural source which act as a “system.” The benefits of using MDMSs to treat paediatric conditions such as gastrointestinal disorders and obesity have been proven, although there remains a degree of uncertainty about the precise mechanism of action underlying their therapeutic effectiveness. This paper argues in favour of using MDSMs when there is scientific grounds to prove their efficacy.

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

“…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.…”