1. 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
- Author
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Els Wessels, Leo H.J. Jacobs, Sjoerd A A van den Berg, Hanneke W. M. van Deutekom, Wytze P. Oosterhuis, Paul C D Bank, Bastiaan B J Tops, Jesse J. Swen, Mirjam M.C. Wamelink, Claudia A. L. Ruivenkamp, Dörte Hamann, Richard Molenkamp, Clinical Chemistry, and Virology
- Subjects
030213 general clinical medicine ,medicine.medical_specialty ,business.industry ,Task force ,Interpretation (philosophy) ,Biochemistry (medical) ,Clinical Biochemistry ,Medical laboratory ,Legislation ,General Medicine ,030204 cardiovascular system & hematology ,Letter to Editor ,Diagnostic Test Approval ,In vitro diagnostic ,Test (assessment) ,03 medical and health sciences ,0302 clinical medicine ,Multidisciplinary approach ,medicine ,Medical physics ,business - Abstract
The in vitro diagnostic medical devices regulation (IVDR) will take effect in May 2022. This regulation has a large impact on both the manufacturers of in vitro diagnostic medical devices (IVD) and clinical laboratories. For clinical laboratories, the IVDR poses restrictions on the use of laboratory developed tests (LDTs). To provide a uniform interpretation of the IVDR for colleagues in clinical practice, the IVDR Task Force was created by the scientific societies of laboratory specialties in the Netherlands. A guidance document with explanations and interpretations of relevant passages of the IVDR was drafted to help laboratories prepare for the impact of this new legislation. Feedback from interested parties and stakeholders was collected and used to further improve the document. Here we would like to present our approach to our European colleagues and inform them about the impact of the IVDR and, importantly we would like to present potentially useful approaches to fulfill the requirements of the IVDR for LDTs.
- Published
- 2020