Annex VI AI Act
class="oj-doc-ti" id="d1e38-133-1">ANEXO VI
Official text
id="anx_VI"> ANEXO VI Procedimento de avaliação da conformidade baseado no controlo interno
1. O procedimento de avaliação da conformidade baseado no controlo interno é o descrito nos pontos 2, 3 e 4.
2. O prestador verifica se o sistema de gestão da qualidade aplicado se encontra em conformidade com os requisitos do artigo 17.o.
3. O prestador analisa as informações contidas na documentação técnica para determinar a conformidade do sistema de IA com os requisitos essenciais aplicáveis estabelecidos no capítulo III, secção 2.
4. O prestador também verifica se o processo de conceção e desenvolvimento do sistema de IA e do seu acompanhamento pós-comercialização a que se refere o artigo 72.o estão de acordo com a documentação técnica.
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.