2 docs tagged with "annex-viii"

MDR 2017/745, Annex VIII. All 22 classification rules must be applied systematically. Where more than one rule applies, the highest resulting class prevails.

IVDR 2017/746, Annex VIII. Seven rules classify IVDs based on the risk posed by the diagnostic information they generate, the severity of conditions they detect, and the vulnerability of the populations they serve.