Experience With IVDR Implementation in Three Diagnostic Laboratories: Messages to EU Health Institutions, Diagnostic Healthcare Payers, and Authorities-Reference-Cited by-同舟云学术

Experience With IVDR Implementation in Three Diagnostic Laboratories: Messages to EU Health Institutions, Diagnostic Healthcare Payers, and Authorities

Published:2023-03-07 Issue:4 Volume:7 Page:e865
ISSN:2572-9241
Container-title:HemaSphere
language:en
Short-container-title:

Author:

Lubbers Bart R.¹²,Dombrink Isabel¹³,Kalina Tomas⁴,Hofmans Mattias⁵,Bruun Morten S.⁶,Stanworth Simon J.¹⁷,Béné Marie C.¹⁸,Döhner Konstanze¹⁹,Brüggemann Monika¹³,Macintyre Elizabeth¹¹⁰,van Dongen Jacques J.M.¹²¹¹¹²

Affiliation:

1. EHA Taskforce on IVD, European Hematology Association, The Hague, The Netherlands

2. European Scientific Foundation for Laboratory Hemato Oncology, Zutphen, The Netherlands

3. Department of Hematology, University Hospital Schleswig-Holstein, Kiel, Germany

4. CLIP, Department of Paediatric Haematology/Oncology, 2nd Faculty of Medicine, Charles University, Prague, Czech Republic

5. Department of Laboratory Medicine, Ghent University Hospital, Belgium

6. Danish Medicines Agency, Copenhagen, Denmark

7. NHS Blood and Transplant, Oxford University Hospitals NHS Trust, University of Oxford, United Kingdom

8. Department of Hematology/Biology, CHU Nantes, France

9. Department of Internal Medicine III, University Hospital of Ulm, Germany

10. Hematology, Université Paris Cité, Assistance Publique – Hôpitaux de Paris, France

11. Centro de Investigación del Cáncer-Instituto de Biología Molecular y Celular del Cáncer (CIC-IBMCC, USAL-CSIC-FICUS), Department of Medicine, University of Salamanca, Spain

12. Department of Immunology, Leiden University Medical Center, The Netherlands

Publisher

Wiley

Subject

Hematology

Reference6 articles.

1. 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

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

3. Critical implications of IVDR for innovation in diagnostics: input from the biomed alliance diagnostics task force.;Dombrink;HemaSphere,2022

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. The end of the laboratory developed test as we know it? Recommendations from a national multidisciplinary taskforce of laboratory specialists on the interpretation of the IVDR and its complications.;Bank;Clin Chem Lab Med,2020