EU/673
WTO/TBT
CE Europäische Union
  • 11 - Medizintechnik
2019-10-08
2019-08-12

In vitro diagnostic medical devices

Draft Commission Implementing Decision amending Decision 2002/364/EC as regards definitions of first-line assays and confirmatory assays, requirements for devices for self-testing and requirements for HIV and HCV rapid tests, confirmatory and supplementary assays (3 pages + Annex 6 pages, in English)

This draft decision updates the common technical specifications, provided for in article 5.3 of the Directive 98/79/EC on in vitro diagnostic medical devices, for some in vitro diagnostic medical devices according to the state of the art, notably definitions of first line and confirmatory assays, requirements for self-tests and requirements for HIV and hepatitis C virus rapid tests and confirmatory assays.