Out of Compass v1 scope
Reprocessed single-use devices (Article 17)
Reprocessing of single-use devices falls under Article 17 — the reprocessor becomes the manufacturer and must comply with MDR as such, with additional national requirements that vary by Member State.
Recommended next step
Treat reprocessing as a new manufacture event under Article 17, complete a fresh conformity assessment, and consult national law (several Member States ban or restrict the practice).
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.