Display of commercial handling of medical devices Unfortunately this specification of service has not yet been completely translated.

If you

  • place on the market for the first time on medical devices or in vitro diagnostics;
  • Treatmedical devices which are intended to be low-germ or sterile, exclusively for other processing,
  • assemble systems or treatment units or sterilize them and medical devices

you have to show this to the competent authority.

  • the common technological characteristics and analytes relating to reagents, medical devices containing reagents and calibration and control materials, and other in vitro diagnostics, the appropriate information
  • in the case of in vitro diagnostics referred to in Annex II to Directive 98/79/EC and in vitro diagnostics for in-house use, all the information enabling the identification of these in vitro diagnostics, the analytical and, where appropriate diagnostic performance data, in accordance with Section A To pt 3 of Annex I to Directive 98/79/EC, the results of the performance assessment and information on certificates
  • in addition, in the case of a "new in vitro diagnostic" within the meaning that it is a "new in vitro diagnostic"

Related Links

  • § 25 Gesetz über Medizinprodukte (MPG)

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