Out of Compass v1 scope
In vitro diagnostics (IVDR)
IVDs are regulated under IVDR (Regulation 2017/746), a separate regulation from MDR with its own risk classes (A/B/C/D) and conformity assessment routes. Compass v1 covers MDR only.
Recommended next step
Consult IVDR Annex VIII for IVD classification rules, and identify the relevant Notified Body for IVDR (different list from MDR NBs). Compass v2 will cover IVDR.
Compass covers all MDR risk classes (I–III) under Annex II/III. These categories fall under a different regulatory regime, so we route you to the right resources instead of guessing.