TY - JOUR
T1 - The end of the laboratory developed test as we know it?
T2 - Recommendations from a national multidisciplinary taskforce of laboratory specialists on the interpretation of the IVDR and its complications
AU - Bank, Paul C D
AU - Jacobs, Leo H J
AU - van den Berg, Sjoerd A A
AU - van Deutekom, Hanneke W M
AU - Hamann, Dörte
AU - Molenkamp, Richard
AU - Ruivenkamp, Claudia A L
AU - Swen, Jesse J
AU - Tops, Bastiaan B J
AU - Wamelink, Mirjam M C
AU - Wessels, Els
AU - Oosterhuis, Wytze P
N1 - Publisher Copyright:
© 2020 Walter de Gruyter GmbH, Berlin/Boston 2020.
PY - 2021/2/1
Y1 - 2021/2/1
N2 - 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.
AB - 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.
KW - diagnostic medical devices regulation (IVDR)
KW - diagnostic test approval
KW - implementation
KW - laboratory developed test
KW - laboratory medicine
KW - legislation
KW - medical device legislation
KW - quality assessment
UR - http://www.scopus.com/inward/record.url?scp=85098948095&partnerID=8YFLogxK
U2 - 10.1515/cclm-2020-1384
DO - 10.1515/cclm-2020-1384
M3 - Article
C2 - 33554568
SN - 1434-6621
VL - 59
SP - 491
EP - 497
JO - Clinical Chemistry and Laboratory Medicine
JF - Clinical Chemistry and Laboratory Medicine
IS - 3
ER -