EU/468
WTO/TBT
CE Europäische Union
  • 11 - Medizintechnik
2017-05-30
2017-04-03
In vitro diagnostic medical devices.

Draft Commission Decision amending Decision 2002/364/EC as regards requirements for HCV antigen/antibody combined tests and Nucleic Acid Amplification techniques in qualitative HIV assays (3 pages + Annex 2 pages, in English)

This draft decision updates the common technical specifications, set out 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/antigen combined tests and Nucleic Acid Amplification techniques ("NAT") assays for HIV.