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

Bank, P.C.D.; Jacobs, L.H.J.; Berg, S.A.A. van den; Deutekom, H.W.M. van; Hamann, D.; Molenkamp, R.; Ruivenkamp, C.A.L.; Swen, J.J.; Tops, B.B.J.; Wamelink, M.M.C.; Wessels, E.; Oosterhuis, W.P.

doi:doi:10.1515/cclm-2020

Bank, P.C.D.; Jacobs, L.H.J.; Berg, S.A.A. van den; Deutekom, H.W.M. van; Hamann, D.; Molenkamp, R.; ... ; Oosterhuis, W.P. (2021)

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

Article / Letter to editor

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, importantlywewould like to present potentially useful approaches to fulfill the...Show moreThe 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, importantlywewould like to present potentially useful approaches to fulfill the requirements of the IVDR for LDTs.Show less

diagnostic test approval

diagnostic medical devices regulation (IVDR)

implementation

laboratory developed test

laboratory medicine

legislation

medical device legislation

quality assessment