Out of Compass v1 scope
System / procedure packs (Article 22)
Systems and procedure packs that combine CE-marked devices follow Article 22 — a streamlined route based on a person responsible for the system/pack, not a full conformity assessment of the pack itself.
Recommended next step
Confirm every component is independently CE-marked and follow the Article 22 declaration procedure. No new conformity assessment of the pack as a whole is required.
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.