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.

Bart R Lubbers^{1

2}, Isabel Dombrink^{1

3}, Tomas Kalina⁴, Mattias Hofmans⁵, Morten S Bruun⁶, Simon J Stanworth^{1

7}, Marie C Béné^{1

8}, Konstanze Döhner^{1

9}, Monika Brüggemann^{1

3}, Elizabeth Macintyre^{1

10}, Jacques J M van Dongen^{1

2

11

12}

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.

No abstract available

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