CerviGuard regulatory posture and publication status
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Document status: Draft for legal/regulatory reviewLast updated: 2026-02-17Owner: Regulatory + Legal
CerviGuard is positioned under MDR Class I with detailed declaration identifiers pending publication and final legal/regulatory sign-off.
Intended use
CerviGuard is intended as a cervical screening companion software application that supports structured case intake, AI-assisted triage support, and follow-up coordination under clinician oversight. It is not intended for autonomous diagnosis or autonomous therapeutic decision-making.
Regulatory declaration summary
| Field | Current public value |
|---|---|
| Manufacturer | SMARTCLOVER SRL |
| Product | CerviGuard |
| Jurisdiction scope | European Union and Romania |
| Classification statement | Positioned under MDR Rule 11 as Class I (draft rationale) |
| Declaration identifier | Pending publication after legal/regulatory sign-off |
| Public draft artifact | CerviGuard MDR Class I Self-Assessment Draft (PDF) |
Complaint and post-market process
- Capture and triage product complaints through controlled intake channels.
- Assess severity and potential patient-safety impact with documented review ownership.
- Trigger corrective actions, release controls, and communication workflow when needed.
- Maintain traceable records for post-market follow-up and regulatory review readiness.
Publication limitations
Final declaration identifiers, document numbering, and release metadata are intentionally withheld until legal and regulatory publication approval is completed.