[Changes and Related Reflections on the European Union's in Vitro Diagnostic Medical Device Classification Supervision System]

Liangbin Zhou; Le Cui; Juan Cheng; Ying Huang

doi:10.3969/j.issn.1671-7104.2021.06.017

[Changes and Related Reflections on the European Union's in Vitro Diagnostic Medical Device Classification Supervision System]

Zhongguo Yi Liao Qi Xie Za Zhi. 2021 Nov 30;45(6):674-679. doi: 10.3969/j.issn.1671-7104.2021.06.017.

[Article in Chinese]

Authors

Liangbin Zhou¹, Le Cui², Juan Cheng¹, Ying Huang²

Affiliations

¹ Guangdong Medical Devices Quality Surveillance and Test Institute, Guangzhou, 510663.
² National Institutes for Food and Drug Control, Beijing, 100050.

PMID: 34862783
DOI: 10.3969/j.issn.1671-7104.2021.06.017

Abstract

By analyzing and comparing the IVD product classification supervision system in the EU's new IVDR, old IVDD and related guidance documents, concepts of related regulatory reforms were analyzed and explored, to provide references for industrial personnel to understand and master the new EU IVD classification system, and for China's ongoing classification management reform.

Keywords: European Union; classification supervision system; in vitro diagnostic medical device; regulation.

MeSH terms

European Union
Industry*
Reagent Kits, Diagnostic*

Substances

Reagent Kits, Diagnostic