Annex VI AI Act
Διαδικασία αξιολόγησης της συμμόρφωσης με βάση τον εσωτερικό έλεγχο
Official text
Διαδικασία αξιολόγησης της συμμόρφωσης με βάση τον εσωτερικό έλεγχο
1. Η διαδικασία αξιολόγησης της συμμόρφωσης με βάση τον εσωτερικό έλεγχο είναι η διαδικασία αξιολόγησης που βασίζεται στα σημεία 2, 3 και 4.
2. Ο πάροχος ελέγχει αν το σύστημα διαχείρισης ποιότητας που έχει θεσπιστεί συμμορφώνεται με τις απαιτήσεις του άρθρου 17.
3. Ο πάροχος εξετάζει τις πληροφορίες που περιέχονται στον τεχνικό φάκελο προκειμένου να αξιολογήσει τη συμμόρφωση του συστήματος ΤΝ με τις σχετικές βασικές απαιτήσεις που καθορίζονται στο κεφάλαιο III τμήμα 2.
4. Ο πάροχος ελέγχει επίσης αν η διαδικασία σχεδιασμού και ανάπτυξης του συστήματος ΤΝ και η παρακολούθησή του μετά τη διάθεση στην αγορά, όπως αναφέρεται στο άρθρο 72, είναι σύμφωνες με τον τεχνικό φάκελο.
Source: EUR-Lex, Regulation (EU) 2024/1689 — text reproduced verbatim.
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What does Annex VI of the AI Act describe?
Annex VI describes the conformity assessment procedure based on internal control. This is the simplest procedure where the provider self-assesses conformity without involvement of a notified body.
What steps does the internal control procedure consist of?
The procedure has three steps: (1) verify the quality management system complies with Article 17, (2) assess the technical documentation for conformity with Chapter III Section 2 requirements, and (3) verify that design, development and post-market monitoring are consistent with the technical documentation.
When can I use the internal control procedure of Annex VI?
Internal control is the default procedure for most high-risk AI systems. Only for biometric AI systems (Annex III, point 1) is assessment by a notified body (Annex VII) mandatory, unless harmonised standards have been fully applied.
Do I need a quality management system for Annex VI?
Yes, step 1 of the procedure requires the provider to verify that the quality management system complies with Article 17 requirements. This system must be established before the conformity assessment.
What is the difference between Annex VI and Annex VII?
Annex VI (internal control) is a self-assessment by the provider. Annex VII requires assessment by a notified body that evaluates and certifies the quality management system and technical documentation.
Do I need to obtain a certificate after internal control?
No, under the Annex VI internal control procedure, the provider issues the EU declaration of conformity themselves (per Annex V). No certificate from a notified body is required.
How do I prove I performed the internal control?
By maintaining the technical documentation (Annex IV) and quality management system (Article 17), issuing the EU declaration of conformity (Annex V), and keeping all documentation available for 10 years for authorities.
Do authorities check the internal control afterwards?
Yes, market surveillance authorities may retrospectively check whether the provider correctly performed the procedure. They can request access to the technical documentation and quality management system.