Template: Go/No-Go Decision Record
AI System Identification
| Field | Value |
|---|---|
| System ID | AI-BGI-XXXX |
| Name | |
| Risk level | [ ] High-risk / [ ] Limited / [ ] Minimal |
| Conformity assessment | [ ] Annex VI (Self) / [ ] Annex VII (Third party) |
| Date |
Economic Assessment
| Item | Amount (EUR) |
|---|---|
| Expected 3-year EU revenue | |
| Expected 3-year EU contribution margin | |
| 15% threshold |
Compliance Effort (estimated)
| Item | One-off (EUR) | Annual (EUR) | 3-year total |
|---|---|---|---|
| Risk management system | |||
| Data governance | |||
| Technical documentation | |||
| QMS extension | |||
| Conformity assessment | |||
| Registration | |||
| Post-market monitoring | |||
| External costs (consultancy, Notified Body) | |||
| Total |
CRA Synergies
- [ ] Product is already CRA-compliant → effort reduction ~55%
- [ ] Product has no CRA compliance → full effort
Assessment
| Criterion | Result |
|---|---|
| Compliance effort ≤ 15% of 3Y-CM? | [ ] Yes / [ ] No |
| Annex VII required? | [ ] Yes (→ Auto No-Go) / [ ] No |
| Strategic reasons for EU distribution? | [ ] Yes / [ ] No |
Decision
- [ ] GO EU — Start compliance implementation
- [ ] NO-GO EU — No EU distribution
- [ ] NO-GO EU + Third market — Distribution in third markets only
- [ ] NO-GO EU + AI removal — EU version without AI component
- [ ] Deferred — Await Digital Omnibus / simplification
Justification
[Free text]
Approval
| Prepared by | Date: |
| Approved by (management) | Date: |