The New EU Regulation on In Vitro Diagnostic Medical Devices: Implications and Preparatory Actions for Diagnostic Laboratories

• Bart R. Lubbers,
• Anke Schilhabel,
• Christa M. Cobbaert,
• David Gonzalez,
• Isabel Dombrink,
• Monika Brüggemann,
• W. Marieke Bitter,
• Jacques J.M. van Dongen

Affiliations

Bart R. Lubbers

1 Department of Immunology, Leiden University Medical Center, Leiden, The Netherlands

Anke Schilhabel

2 Department of Hematology, University Hospital Schleswig-Holstein, Kiel, Germany

Christa M. Cobbaert

3 Department of Clinical Chemistry and Laboratory Medicine, Leiden University Medical Center, Leiden, The Netherlands

David Gonzalez

4 Centre for Cancer Research and Cell Biology, Queen’s University Belfast, Belfast, United Kingdom

Isabel Dombrink

2 Department of Hematology, University Hospital Schleswig-Holstein, Kiel, Germany

Monika Brüggemann

2 Department of Hematology, University Hospital Schleswig-Holstein, Kiel, Germany

W. Marieke Bitter

1 Department of Immunology, Leiden University Medical Center, Leiden, The Netherlands

Jacques J.M. van Dongen

1 Department of Immunology, Leiden University Medical Center, Leiden, The Netherlands