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Medical Devices Made of Substances: A New Challenge

Authors :
Leone, Maria Grazia
Source :
Frontiers in Drug Safety and Regulation. 2
Publication Year :
2022
Publisher :
Frontiers Media SA, 2022.

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.

Details

ISSN :
26740869
Volume :
2
Database :
OpenAIRE
Journal :
Frontiers in Drug Safety and Regulation
Accession number :
edsair.doi.dedup.....1e1b2ec3ad74083ef6322af2841db0c3
Full Text :
https://doi.org/10.3389/fdsfr.2022.952013