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"


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Last update or date of publication
19.11.2009