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Laboratory-developed tests in the New European Union 2017/746 Regulation: opportunities and risks

In vitro diagnostics (IVD) in the European Union (EU) is facing fundamental change with the implementation of a new regulation termed in vitro diagnostic medical device regulation (IVDR) (1). Going into full effect in May 2022, IVDR will affect 447 million people in 27 countries. There is substantia...

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Bibliographische Detailangaben
Hauptverfasser: Vogeser, Michael (VerfasserIn) , Brüggemann, Monika (VerfasserIn) , Lennerz, Jochen K. (VerfasserIn) , Stenzinger, Albrecht (VerfasserIn) , Gassner, Ulrich M. (VerfasserIn)
Dokumenttyp: Article (Journal)
Sprache:Englisch
Veröffentlicht: 2022
In: Clinical chemistry
Year: 2022, Jahrgang: 68, Heft: 1, Pages: 40-42
ISSN:1530-8561
DOI:10.1093/clinchem/hvab215
Online-Zugang:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1093/clinchem/hvab215
Volltext
Verfasserangaben:Michael Vogeser, Monika Brüggemann, Jochen Lennerz, Albrecht Stenzinger, and Ulrich M. Gassner
Beschreibung
Zusammenfassung:In vitro diagnostics (IVD) in the European Union (EU) is facing fundamental change with the implementation of a new regulation termed in vitro diagnostic medical device regulation (IVDR) (1). Going into full effect in May 2022, IVDR will affect 447 million people in 27 countries. There is substantial concern that IVDR will result in over-regulation and potentially result in “the end of the laboratory-developed tests as we know it” (2).In this context, it should be noted that in the USA, the topic of regulation of in-house procedures—and in particular potential regulation of medical practice—has been a subject of controversy for a considerable time and a definitive conclusion is still pending (3-6).
Beschreibung:Accepted September 21, 2021
Gesehen am 08.03.2022
Beschreibung:Online Resource
ISSN:1530-8561
DOI:10.1093/clinchem/hvab215

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