The IVDR in-house exemption and what it costs to rely on
How Article 5(5) of the IVDR allows a health institution to make and use its own in vitro diagnostic, and the nine conditions attached.
Tag: in-vitro-diagnostics
4 posts
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.
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.