Does customer information fulfill MEDDEV criteria in cases of product problems of in vitro diagnostics for infection testing?

@article{Hannig2014DoesCI,
  title={Does customer information fulfill MEDDEV criteria in cases of product problems of in vitro diagnostics for infection testing?},
  author={J{\"u}rgen Hannig and Ruediger Siekmeier},
  journal={Advances in experimental medicine and biology},
  year={2014},
  volume={835},
  pages={
          23-30
        }
}
The European Directive 98/79/EC on in vitro diagnostics (IVD) regulates marketing and post market surveillance of IVD in the European Economic Area. In cases of incidents and field safety corrective actions (FSCA) manufacturers have to inform responsible competent authority (CA) and public by field safety notices (FSN). We analyzed FSCA and FSN of IVD for infection testing (culture media, reagents, kits, control materials, as well as culture-based analyzers and their general consumables… CONTINUE READING
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