Annex III Category 5
Healthcare & Essential Services
Spans medical devices (Aug 2027) and public services (Aug 2026). No autonomous denial of benefits or triage.
Requirement Mapping
| Requirement | Article | Complexity | SupraWall Template |
|---|---|---|---|
| Tamper-evident automatic logging of inputs, outputs, and decisions | Art. 12 | CRITICAL | Pre-configured |
| Human oversight mechanism — ability to review and override agent decisions | Art. 14 | CRITICAL | Pre-configured |
| Risk management system for the AI system lifecycle | Art. 9 | CRITICAL | Pre-configured |
Build vs. Template
The true cost of implementing EU AI Act compliance from scratch.
| Approach | Time | Cost | Maintenance | Evidence | Audit-Ready |
|---|---|---|---|---|---|
| Build from scratch | 22–36 weeks | €88,000–€144,000 | Ongoing engineering | Manual collection | HIGH AUDIT RISK |
SupraWall Template | 15 MINS | Developer Tier | Automatic updates | Auto-generated PDF | CERTIFIED EVIDENCE |
Technical FAQ
Common regulatory hurdles for $Healthcare & Essential Services.
Q:What is the medical device deadline?
A:AI embedded in medical devices has an extension until August 2027.
Deploy This Blueprint
Activate all 13 baseline controls and sector logic in one line.
One-Line Activation
typescript
import { useCompliance } from '@suprawall/sdk';
// One-line activation for Annex III healthcare compliance
const agent = useCompliance({
template: 'healthcare'
});