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Medical device legislation and POCT

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Point-of-Care Testing

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Abstract

This chapter focuses on the regulatory framework for medical devices according to European law, the German Medical Devices Act (MPG) and their subordinate regulations. On the one hand, extensive requirements for quality assurance during production of these products can be directly derived from European legislation governing in vitro diagnostic medical devices (IVD). On the other hand, the legally required quality assurance measures during operation and use of the diagnostic devices can be seen as indirect consequences of the regulations set down in the IVD Directive. The chapter also describes an essential revision to the European legislation on medical devices finally performed by publication of the Regulation (EU) 2017/746. IVD, self-evidently including POCT, will then be regulated by a separate, directly applicable European regulation.

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Author information

Authors and Affiliations

  1. bei Arzneimitteln und Medizinprodukten (ZLG), Zentralstelle der Länder für Gesundheitsschutz, Heinrich-Böll-Ring 10, 53119, Bonn, Germany

    Dr. Folker Spitzenberger

  2. Zentrum für Labormedizin und Mikrobiologie, Herwarthstraße 100, 45138, Essen, Germany

    Dr. Claus Langer

  3. Forschungsstelle für Medizinprodukterecht (FMPR), Universitätsstr. 24, 86159, Augsburg, Germany

    Prof. Dr. Ulrich M. Gassner

Authors
  1. Dr. Folker Spitzenberger
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  2. Dr. Claus Langer
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  3. Prof. Dr. Ulrich M. Gassner
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Editor information

Editors and Affiliations

  1. Klinikum rechts der Isar, München, Germany

    Peter B. Luppa

  2. Universitätsklinikum Schleswig-Holstein, Kiel, Germany

    Ralf Junker

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Spitzenberger, F., Langer, C., Gassner, U.M. (2018). Medical device legislation and POCT. In: Luppa, P.B., Junker, R. (eds) Point-of-Care Testing. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-662-54497-6_25

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