Class IIb — beyond Compass v1 scope
Your device profile classifies as Class IIb under MDR Annex VIII. The classification itself is correct, but Compass v1 only carries the strategic-report data (doc inventory, conformity-assessment route, clinical pathway, cost/timeline envelope) for Class I and IIa. Class IIb follows a conformity-assessment route that includes a Notified Body review of the technical documentation on a representative basis (Annex IX §4 or Annex X / Annex XI Part A) and has materially higher clinical-evidence expectations than IIa.
Recommended next step
Engage a Notified Body and a regulatory consultant early. Class IIb submissions require NB involvement in the technical-file review, formal clinical evaluation, and a defined post-market clinical follow-up plan. Compass v2 will extend coverage to Class IIb and III.
Compass v1 covers Class I and IIa devices under MDR Annex II/III only. We may expand coverage in v2.