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 v1 covers Class I and IIa devices under MDR Annex II/III only. We may expand coverage in v2.