Out of Compass v1 scope
Custom-made devices
Custom-made devices follow Annex XIII, not the Annex II/III route Compass v1 covers. They are produced for a specific patient on prescription and have a separate conformity assessment path.
Recommended next step
Consult a regulatory expert familiar with Annex XIII custom-made device procedures. The Tech File requirements and post-market obligations differ materially from Class I/IIa series production.
Compass v1 covers Class I and IIa devices under MDR Annex II/III only. We may expand coverage in v2.