Critical Implications of IVDR for Innovation in Diagnostics: Input From the BioMed Alliance Diagnostics Task Force-Reference-Cited by-同舟云学术

Critical Implications of IVDR for Innovation in Diagnostics: Input From the BioMed Alliance Diagnostics Task Force

Published:2022-05-20 Issue:6 Volume:6 Page:e724
ISSN:2572-9241
Container-title:HemaSphere
language:en
Short-container-title:

Author:

Dombrink Isabel,Lubbers Bart R.,Simulescu Loredana,Doeswijk Robin,Tkachenko Olga,Dequeker Elisabeth,Fraser Alan G.,van Dongen Jacques J. M.,Cobbaert Christa,Brüggemann Monika,Macintyre Elizabeth

Publisher

Ovid Technologies (Wolters Kluwer Health)

Subject

Hematology

Reference11 articles.

1. Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices.;Official J Eur Commun,1998

2. Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU.;Official J Eur Union,2017

3. The new EU regulation on in vitro diagnostic medical devices: implications and preparatory actions for diagnostic laboratories.;Lubbers;HemaSphere,2021

4. The new IVD Regulation 2017/746: a case study at a large university hospital laboratory in Belgium demonstrates the need for clarification on the degrees of freedom laboratories have to use lab-developed tests to improve patient care.;Vermeersch;Clin Chem Lab Med,2020

5. Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health technology assessment and amending Directive 2011/24/EU.;Official J Eur Union,2021

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