Since 1965, the introduction on the market of any therapeutic product requires a development process aimed at guaranteeing its quality, safety and efficacy. Treatments without any proof of efficacy are often used by people, with or without medical prescription for their medical need. Substance-based medical devices are medical devices that are composed of substances or of combinations of substances. Although they are similar to medicinal products in their presentation and pharmaceutical form, they achieve their principal intended effect via a non pharmacological, immunological or metabolic mechanism of action.
Medical Device Regulation 2017/745/EC (MDR), in force since May 2021, will create a regulatory framework, recognised internationally, that will oblige to demonstrate a clinical benefits for medical devices made of substances. The MDR furthermore will offer an exceptional opportunity for those medical devices made of substances or complex of substances which are systemically absorbed in order to achieve their intended use. This requires gaining insight and showing evidence on how complex systems exert their clinical positive systemic effect and represents a challenge for preclinical and clinical research.
The section aims to be a platform for exchange of experience and discussion regarding the world of medical devices made of substances at all stages of their life cycle. General topics of interest may include:
? Clinical indications for medical devices made of substances
? Use in every day clinical practice
? Modes of action of a medical device made of substances (synthetic, natural, single molecule, natural
complex)
? Emergent properties of natural systems, applications in quality, performance and clinical benefit
assessments
? Clinical studies (protocols and results)
? Interactions affecting efficacy and safety of prescribed medications
? Pharmacovigilance and post market surveillance,
? Challenges in manufacturing techniques and storage methods
? Quality control of natural complex substances (sources of contaminants, assay)
? Regulatory experience in Europe and beyond.
? Green manufacturing methods
Since 1965, the introduction on the market of any therapeutic product requires a development process aimed at guaranteeing its quality, safety and efficacy. Treatments without any proof of efficacy are often used by people, with or without medical prescription for their medical need. Substance-based medical devices are medical devices that are composed of substances or of combinations of substances. Although they are similar to medicinal products in their presentation and pharmaceutical form, they achieve their principal intended effect via a non pharmacological, immunological or metabolic mechanism of action.
Medical Device Regulation 2017/745/EC (MDR), in force since May 2021, will create a regulatory framework, recognised internationally, that will oblige to demonstrate a clinical benefits for medical devices made of substances. The MDR furthermore will offer an exceptional opportunity for those medical devices made of substances or complex of substances which are systemically absorbed in order to achieve their intended use. This requires gaining insight and showing evidence on how complex systems exert their clinical positive systemic effect and represents a challenge for preclinical and clinical research.
The section aims to be a platform for exchange of experience and discussion regarding the world of medical devices made of substances at all stages of their life cycle. General topics of interest may include:
? Clinical indications for medical devices made of substances
? Use in every day clinical practice
? Modes of action of a medical device made of substances (synthetic, natural, single molecule, natural
complex)
? Emergent properties of natural systems, applications in quality, performance and clinical benefit
assessments
? Clinical studies (protocols and results)
? Interactions affecting efficacy and safety of prescribed medications
? Pharmacovigilance and post market surveillance,
? Challenges in manufacturing techniques and storage methods
? Quality control of natural complex substances (sources of contaminants, assay)
? Regulatory experience in Europe and beyond.
? Green manufacturing methods
