Search results with tag "The in vitro diagnostic"

Clinical Evidence Requirements for CE certification under ...

legislation and affix a CE mark to their product. Since the 1990s, in-vitro diagnostics (IVDs) have been regulated by an EU Directive (IVD Directive 98/79/EC). In May 2017, the In-Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) was published. MedTech Europe, the European trade association

  Directive, Diagnostics, Vitro, The in vitro diagnostic