Complete conformity assessment before market

Pass the applicable conformity-assessment procedure (internal control or notified body) demonstrating the requirements are met, before placing the high-risk system on the market.

Applies to

Provider

Scope

High-risk (Annex III use case), High-risk (Annex I regulated product)

Applies from

2027-12-02 — Stand-alone high-risk (Annex III) obligations apply

Derives from

Article 43

Primary source

Art. 43 AIA

Evidence an auditor expects

• EU Declaration of Conformity — Signed declaration that the high-risk system meets AIA requirements (Annex IV(7)).
• Annex IV technical file — The full technical documentation package; primary evidence at conformity assessment; must be a living, versioned document.

FAQ

What evidence do I need for Article 43?
EU Declaration of Conformity, Annex IV technical file. Each should be contemporaneous, versioned, and traceable to the system version.

When does “Complete conformity assessment before market” apply?
From 2027-12-02 — Stand-alone high-risk (Annex III) obligations apply. It applies to: Provider.

What fails an audit here?
Missing or retroactively-created documentation.

Legal source

Art. 43 AIA

Explained in the newsletter

• Conformity assessment: who on your team owns each component of the technical file

Not legal advice. This is a practitioner reference generated from a cited knowledge base built on the primary legal text and official Commission guidance. Verify against the cited primary sources before relying on it for a compliance decision. See editorial standards & methodology.