Experience With IVDR Implementation in Three Diagnostic Laboratories: Messages to EU Health Institutions, Diagnostic Healthcare Payers, and Authorities
Hemasphere. 2023 Mar 7;7(4):e865.
doi: 10.1097/HS9.0000000000000865.
eCollection 2023 Apr.
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.