Working through the IVDR classification rules
How Annex VIII of Regulation (EU) 2017/746 assigns in vitro diagnostics to classes A, B, C and D, and what each class determines.
Tag: in-vitro-diagnostics
3 posts
What one assay has to prove under FDA and under the IVDR
How FDA classification and special controls compare with IVDR performance evaluation in the evidence a single in vitro diagnostic has to generate.
Analytical validity, clinical validity and clinical utility
How 21 CFR Part 862 special controls separate analytical performance, clinical performance and claims about patient management for in vitro diagnostics.