What is "post-market monitoring" in plain language?

It is how you prove the system stays safe and fit-for-purpose after go-live: what you measure, how you review samples, and how you respond to incidents and changes.

What does Article 72 require?

Article 72 requires active data collection on system performance, identification of needs for corrective action, and documentation of monitoring activities. This template covers all three requirements.

What is the difference between alerting and incident response?

Alerting detects issues and notifies the right people. Incident response defines what happens after detection: assessment, containment, investigation, resolution, and documentation.

What triggers Article 73 regulatory reporting?

Serious incidents involving high-risk AI systems must be reported to market surveillance authorities immediately upon becoming aware. The template includes a regulatory reporting section.

How do we ensure evidence integrity?

Use tamper-proof storage (append-only ledger with cryptographic integrity), complete capture at decision points, access logging, and regular integrity audits.

What do auditors reject most often?

Plans that are generic. Auditors want named owners, specific thresholds, clear escalation procedures, and evidence that can be exported and verified independently.

Template

Post-market Monitoring Plan Template (Article 72 compliant)

Download an Article 72 compliant post-market monitoring plan template covering system identification, monitoring objectives, data collection, performance metrics, alerting, review procedures, incident response, and documentation.

Generate a reviewable post-market monitoring plan in 30-60 minutes.

For compliance, risk, product, and ML ops teams shipping agentic workflows into regulated environments.

Zuletzt aktualisiert: 16. Dez. 2025 · Version v1.0 · Fiktives Beispiel. Keine Rechtsberatung.

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Kontext

Was dieses Artefakt ist (und wann Sie es brauchen)

Minimal funktionsfähige Erklärung, geschrieben für Audits, nicht für Theorie.

The EU AI Act Article 72 requires providers of high-risk AI systems to establish and document a post-market monitoring system. This is not optional. It is a compliance requirement with specific mandates for how you monitor AI systems after deployment.

This template provides a structured 8-section approach covering system identification, monitoring objectives, data collection, performance metrics, alerting, review procedures, incident response, and documentation.

Sie brauchen dies, wenn

You are deploying an agent into a regulated workflow (credit, claims, KYC/AML, HR).
You need to prove ongoing quality, safety, and policy compliance after go-live.
You are preparing an Annex IV dossier or an audit readiness review.

Common failure mode

A plan that lists metrics but has no thresholds, no named owners, no alert escalation procedures, and no incident response workflow tied to exportable evidence.

Checkliste

Erfolgskriterien

Akzeptanzkriterien, die Prüfer tatsächlich überprüfen.

System identification links to regulatory classification and Annex IV documentation.
Monitoring objectives connect to identified risks with clear success criteria.
Data collection covers all sources with quality requirements and privacy considerations.
Performance metrics include technical, drift, and fairness thresholds with severity levels.
Alerting defines severity levels, notification matrix, and escalation procedures.
Review procedures include continuous monitoring, sampling, and periodic governance reviews.
Incident response covers definition, immediate response, investigation, and Article 73 reporting.
Documentation and evidence storage ensures tamper-proof retention with audit readiness.

Vorschau

Vorlagenvorschau

Ein echter Auszug in HTML, damit er indexierbar und prüfbar ist.

Template preview (excerpt)

## Section 4: Performance Metrics

### 4.1 Technical Performance Metrics
| Metric | Definition | Threshold | Alert Level |
|--------|------------|-----------|-------------|
| [Accuracy] | [% correct predictions] | [>95%] | [Critical if <90%] |

### 4.2 Drift Metrics
| Metric | Calculation Method | Threshold | Check Frequency |
|--------|-------------------|-----------|-----------------|
| [Feature drift] | [PSI or KL Divergence] | [PSI <0.1] | [Daily] |

## Section 5: Alerting and Escalation

### 5.1 Alert Severity Levels
| Level | Criteria | Response Time |
|-------|----------|---------------|
| Critical | [Immediate risk, compliance violation] | [15 minutes] |
| High | [Significant degradation] | [4 hours] |

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Anleitung

Wie man es (schnell) ausfüllt

Benötigte Eingaben, Zeit zum Abschließen und ein minimales Arbeitsbeispiel.

Benötigte Eingaben

System identification with regulatory classification and Annex IV references.
Monitoring objectives connected to risk register with success criteria.
Data sources, collection frequency, quality requirements, and privacy considerations.
Performance thresholds (technical, drift, fairness) with severity levels.
Alerting configuration with escalation matrix and after-hours coverage.
Review procedures (continuous, sampling, periodic) with governance integration.
Incident response procedures including Article 73 regulatory reporting.

Zeit zum Abschließen: 30-60 minutes for a defensible v1.

Mini example: alert severity

BEISPIEL

Alert Severity Levels:
| Level | Criteria | Response Time |
|-------|----------|---------------|
| Critical | System down, accuracy <90%, discriminatory outcome | 15 minutes |
| High | Accuracy <95%, drift threshold exceeded | 4 hours |
| Medium | Approaching threshold, unusual pattern | 24 hours |
| Low | Minor metric movement, informational | Next business day |

KLA-Mapping

Wie KLA dies generiert (Govern / Measure / Prove)

Verknüpfen Sie das Artefakt mit Produktfunktionen.

Govern

Policy-as-code checkpoints that block or require review for high-risk actions.
Versioned change control for model/prompt/policy/workflow updates.

Measure

Risk-tiered sampling reviews (baseline + burst during incidents or after changes).
Near-miss tracking (blocked / nearly blocked steps) as a measurable control signal.

Prove

Hash-chained, append-only audit ledger with 7+ year retention language where required.
Evidence Room export bundles (manifest + checksums) so auditors can verify independently.

Verwandte Ressourcen

Human oversight playbook Audit log retention policy template Evidence pack checklist AI model card template