EU IVDR 2017/746
The regulation governing in vitro diagnostic devices in the European Union.
'CE marked' under the old directive and under IVDR are not the same claim. Check which one a vendor means.
- Cost
- Free
- Hardware
- Runs on any laptop
- Scanner
- Not required
- Your data
- Stays on your machine
- Licence
- unknown
- Maturity
- production
- From
- European Union
What it is
Full legal text of the In Vitro Diagnostic Regulation, which governs CE marking for diagnostic software including pathology algorithms, and which reclassified much software upward in risk class compared with the previous directive.
Licence notes
Published document; check the publisher's terms for reuse.
Related
Catalogued 2026-08-02, last checked 2026-08-02. View the source record · Report an error