CE Europäische Union
  • 11 - Medizintechnik

In vitro diagnostic medical devices

Draft Commission Implementing Decision amending Decision 2002/364/EC as regards requirements for HIV and HCV antigen and antibody combined tests and as regards requirements for nucleic acid amplification techniques with respect to reference materials and qualitative HIV assays (and its accompanying annex) (3 pages + Annex 4 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 regarding HCV antibody and antigen combined tests and nucleic acid amplification techniques ("NAT") assays for HIV. It differs from the draft decision notified under G/TBT/N/EU/468 in that it covers better combined tests, in particular for HCV.