Applicability · EU AI Act · iFeed Regulations

Regulations/EU AI Act/Applicability

/ Applicability logic

Applicability begins with scope, not assumption.

EU AI Act

Applicability 01

EU nexus

Placed on the EU market, put into EU service, used by EU deployers, or producing output used in the EU.

Applicability 02

Actor role

Provider, deployer, importer, distributor, product manufacturer, authorised representative, or affected person.

Applicability 03

Risk tier

Prohibited, high-risk, transparency-specific, GPAI, or lower-risk use with voluntary governance.

Applicability 04

Life-sciences overlays

MDR/IVDR, clinical, QMS, data protection, cybersecurity, and GxP controls still remain relevant.

/ Dates and gates

Timing changes what can be responsibly claimed.

status gates

Gates

Track these before publishing a checklist or readiness claim.

2024-08-01 entry into force · 2025-02-02 prohibitions and Article 4 AI literacy · 2025-08-02 GPAI/governance/penalties phase · 2026-08-02 main high-risk regime · 2027+ selected product-safety high-risk timing

/ Use cases

Regulated use cases need a decision record.

life sciences lens

Use case 01

Article 3 definitions

Use this as a trigger for EU AI Act applicability review, not as an automatic compliance conclusion. Definitions drive actor, system, risk, and literacy interpretation.

Use case 02

Article 4 AI literacy

Use this as a trigger for EU AI Act applicability review, not as an automatic compliance conclusion. Providers and deployers need literacy measures appropriate to role, context, and people affected.

Use case 03

High-risk classification

Use this as a trigger for EU AI Act applicability review, not as an automatic compliance conclusion. Teams need a documented classification decision rather than a loose label.

Use case 04

Provider / deployer roles

Use this as a trigger for EU AI Act applicability review, not as an automatic compliance conclusion. Obligations depend on role, control, intended use, and deployment context.

Use case 05

Human oversight

Use this as a trigger for EU AI Act applicability review, not as an automatic compliance conclusion. Oversight becomes a planned operating control, not a vague ethical statement.

Use case 06

Technical documentation

Use this as a trigger for EU AI Act applicability review, not as an automatic compliance conclusion. Traceable records connect design, risk, data, testing, and user-facing information.

/ Source anchors

Current public sources for EU AI Act.

official first

These links are the public source anchors for this workspace. Interpretation, checklists, and future assets should point back here before being reused outside iFeed.

Official legal text