Class III — beyond Compass v1 scope
Your device profile classifies as Class III under MDR Annex VIII — the highest risk class. The classification itself is correct, but Compass v1 only carries the strategic-report data for Class I and IIa. Class III devices require a Notified Body design-dossier review (Annex IX §5) or full type-examination (Annex X), a Clinical Evaluation Consultation Procedure for certain device groups, and pre-market clinical investigations for nearly all implantable Class III devices.
Recommended next step
Engage a Notified Body and an experienced regulatory consultant before doing anything else. Class III timelines run 18–36 months and require a clinical-investigation plan, full design-dossier preparation, and (often) a CECP step. 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.