Out of Compass v1 scope
Investigational devices (Annex XV)
Investigational devices undergo a clinical investigation under Annex XV and Article 62 — not the conformity assessment route Compass v1 covers. The submission pathway is via a competent authority application.
Recommended next step
Prepare an Annex XV investigational device application; consult MDCG 2024-12 (clinical investigation guidance) and your competent authority.
Compass v1 covers Class I and IIa devices under MDR Annex II/III only. We may expand coverage in v2.