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

• Published in: Clinical chemistry and laboratory medicine Vol. 59; no. 3; pp. 491 - 497
• Main Authors: Bank, Paul C.D., Jacobs, Leo H.J., van den Berg, Sjoerd A.A., van Deutekom, Hanneke W.M., Hamann, Dörte, Molenkamp, Richard, Ruivenkamp, Claudia A.L., Swen, Jesse J., Tops, Bastiaan B.J., Wamelink, Mirjam M.C., Wessels, Els, Oosterhuis, Wytze P.
• Format: Journal Article
• Language: English
• Published: Germany De Gruyter 23.02.2021; Walter De Gruyter & Company
• Subjects: Complications; diagnostic medical devices regulation (IVDR); Diagnostic systems; diagnostic test approval; implementation; Laboratories; laboratory developed test; laboratory medicine; Legislation; medical device legislation; Medical equipment; Medical laboratories; quality assessment; diagnostic test approval; implementation; quality assessment; medical device legislation; diagnostic medical devices regulation (IVDR); laboratory medicine; laboratory developed test; legislation
• ISSN: 1434-6621; 1437-4331
• DOI: 10.1515/cclm-2020-1384

The diagnostic medical devices regulation (IVDR) will take effect in May 2022. This regulation has a large impact on both the manufacturers of 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.