Abstract
The evolution of medical devices has led to the introduction of medical devices that include “substances” and which, due to their presentation and sites of application may resemble medicinal products. The difference between substance-based medical devices and medicinal products lies in the proper definition of the principal mechanism of action. The major problem at the moment is the lack of a proper procedure for the demonstration of a mechanism that is “not pharmacological, immunological or metabolic.” We aimed to design an experimental set up to demonstrate the difference between the mechanism of action of two substances used commonly for the treatment of constipation, lubiprostone (example of medicinal product) and glycerine (example of medical device). By implementing cellular models and molecular analyses we demonstrate the difference in their mechanism of action. This set up can be considered an example on the possibility to define a paradigm for the case by case study of the mechanism of action of substances and combination of substances in medical devices.
Highlights
Medical devices are a wide category of products that are becoming increasingly important in the healthcare system (Racchi et al, 2016)
The difference between a medical devices made of substances and medicinal products lies in the principal mechanism of action with which they achieve the therapeutic effect, which determines their regulatory classification
We examine the effects of short-term lubiprostone and glycerine treatments on cell morphology and on cyclic AMP (cAMP) second messenger signaling in two specific cellular models, human colonic adenocarcinoma cell line (T84) and human dermal fibroblasts (HuDe), to demonstrate that the mechanism of action of lubiprostone is dependent on the presence of specific biological targets while that of glycerine is not
Summary
Medical devices are a wide category of products that are becoming increasingly important in the healthcare system (Racchi et al, 2016). Their evolution has led to the introduction of medical devices that include “substances” and which, due to their presentation and sites of application may resemble medicinal products. Regulation 2017/745 explicitly addresses “medical devices composed of substances or combination of substances” in many paragraphs and in a specific classification rule (Rule 21). Borderline products exist until their mechanism of action is identified, on a case by case basis, as explicitly required by Regulation 2017/745 (Reg 2017/745 whereas n.8) (Food Drug Administration, 2005; Alexander et al, 2013).
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