In-house diagnostic devices under the EU IVDR and unwanted side-effects of intentional transparency

Author(s):: Vanstapel, F.J.L.A.; Boursier, G.; Cobbaert, C.M.; EFLM Task Force European; EFLM Quality Regulations Comm

Published: 2023
Publication type: Article / Letter to editor

EU Regulation 2017/746in-house testISO 15189laboratory developed testMDCG-2023-1

Date issued: 2023-07-27
Language: English
Publisher: De Gruyter
Is part of: Clinical Chemistry and Laboratory Medicine (2023), No. 1
hdl: 1887/3736603
doi: 10.1515/cclm-2023-0750
URL: https://www.degruyter.com/document/doi/10.1515/cclm-2023-0750/html