AUTHOR=Leone Maria Grazia TITLE=Medical Devices Made of Substances: A New Challenge JOURNAL=Frontiers in Drug Safety and Regulation VOLUME=2 YEAR=2022 URL=https://www.frontiersin.org/journals/drug-safety-and-regulation/articles/10.3389/fdsfr.2022.952013 DOI=10.3389/fdsfr.2022.952013 ISSN=2674-0869 ABSTRACT=

Regulation (EU) 2017/745 provides for new provisions for medical devices made of substances as well as specific classification rules and requirements. The demarcation line between medical devices composed of substances and medicinal products is not always easy to define. The recent publication by the European Commission of the guidance on borderline between medical devices and medicinal products under the Regulation (EU) 2017/745 on medical devices, MDCG 2022-5, addresses some important issues in this topic. This article will discuss some controversial aspects in this field in order to clarify the product qualification process.