Experience with post-market surveillance of in-vitro diagnostic medical devices for lay use in Germany.

@article{Siekmeier2007ExperienceWP,
  title={Experience with post-market surveillance of in-vitro diagnostic medical devices for lay use in Germany.},
  author={Ruediger Siekmeier and Johannes L{\"u}tz},
  journal={Clinical chemistry and laboratory medicine},
  year={2007},
  volume={45 3},
  pages={396-401}
}
BACKGROUND The European Directive 98/79/EC on in-vitro diagnostic medical devices (IVDs) regulates IVD marketing practices and post-market surveillance. IVD manufacturers have to inform the responsible Competent Authorities of any issues. In Germany, the Federal Institute for Drugs and Medical Devices (BfArM) is responsible for most IVDs, with a small subset of IVDs being within the responsibility of the Paul-Ehrlich-Institute (PEI). METHODS All IVD notifications received by BfArM between… CONTINUE READING

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