Brief Introduction about New Regulation of EU on IVDR.
10.3969/j.issn.1671-7104.2021.05.012
- Author:
Zhihui CHEN
1
Author Information
1. Agilent Biosciences (Hangzhou) Co. Ltd., Hangzhou, 310000.
- Publication Type:Journal Article
- Keywords:
EU;
in vitro diagnostic (IVD);
post-market surveillance;
transitional period;
vigilance system
- MeSH:
European Union;
Marketing;
Reagent Kits, Diagnostic
- From:
Chinese Journal of Medical Instrumentation
2021;45(5):530-535
- CountryChina
- Language:Chinese
-
Abstract:
There are five-year transitional period for manufacturers after the issue of regulation(EU) 2017/746 on
