ANNEX VII — Conformity based on an assessment of the quality management system and an assessment of the technical documentation
1.Introduction §
2.Overview §
3.Quality management system §
3.1.The application of the provider shall include: §
(a)the name and address of the provider and, if the application is lodged by an authorised representative, also their name and address; §
(b)the list of AI systems covered under the same quality management system; §
(c)the technical documentation for each AI system covered under the same quality management system; §
(d)the documentation concerning the quality management system which shall cover all the aspects listed under Article 17; §
(e)a description of the procedures in place to ensure that the quality management system remains adequate and effective; §
(f)a written declaration that the same application has not been lodged with any other notified body. §
3.2.The quality management system shall be assessed by the notified body, which shall determine whether it satisfies the requirements referred to in Article 17. §
3.3.The quality management system as approved shall continue to be implemented and maintained by the provider so that it remains adequate and efficient. §
3.4.Any intended change to the approved quality management system or the list of AI systems covered by the latter shall be brought to the attention of the notified body by the provider. §
4.Control of the technical documentation. §
4.1.In addition to the application referred to in point 3, an application with a notified body of their choice shall be lodged by the provider for the assessment of the technical documentation relating to the AI system which the provider intends to place on the market or put into service and which is covered by the quality management system referred to under point 3. §
4.2.The application shall include: §
(a)the name and address of the provider; §
(b)a written declaration that the same application has not been lodged with any other notified body; §
(c)the technical documentation referred to in Annex IV. §
4.3.The technical documentation shall be examined by the notified body. Where relevant, and limited to what is necessary to fulfil its tasks, the notified body shall be granted full access to the training, validation, and testing data sets used, including, where appropriate and subject to security safeguards, through API or other relevant technical means and tools enabling remote access. §
4.4.In examining the technical documentation, the notified body may require that the provider supply further evidence or carry out further tests so as to enable a proper assessment of the conformity of the AI system with the requirements set out in Chapter III, Section 2. Where the notified body is not satisfied with the tests carried out by the provider, the notified body shall itself directly carry out adequate tests, as appropriate. §
4.5.Where necessary to assess the conformity of the high-risk AI system with the requirements set out in Chapter III, Section 2, after all other reasonable means to verify conformity have been exhausted and have proven to be insufficient, and upon a reasoned request, the notified body shall also be granted access to the training and trained models of the AI system, including its relevant parameters. Such access shall be subject to existing Union law on the protection of intellectual property and trade secrets. §
4.6.The decision of the notified body shall be notified to the provider or its authorised representative. The notification shall contain the conclusions of the assessment of the technical documentation and the reasoned assessment decision. §
4.7.Any change to the AI system that could affect the compliance of the AI system with the requirements or its intended purpose shall be assessed by the notified body which issued the Union technical documentation assessment certificate. The provider shall inform such notified body of its intention to introduce any of the abovementioned changes, or if it otherwise becomes aware of the occurrence of such changes. The intended changes shall be assessed by the notified body, which shall decide whether those changes require a new conformity assessment in accordance with Article 43(4) or whether they could be addressed by means of a supplement to the Union technical documentation assessment certificate. In the latter case, the notified body shall assess the changes, notify the provider of its decision and, where the changes are approved, issue to the provider a supplement to the Union technical documentation assessment certificate. §
5.Surveillance of the approved quality management system. §
5.1.The purpose of the surveillance carried out by the notified body referred to in Point 3 is to make sure that the provider duly complies with the terms and conditions of the approved quality management system. §
5.2.For assessment purposes, the provider shall allow the notified body to access the premises where the design, development, testing of the AI systems is taking place. The provider shall further share with the notified body all necessary information. §
5.3.The notified body shall carry out periodic audits to make sure that the provider maintains and applies the quality management system and shall provide the provider with an audit report. In the context of those audits, the notified body may carry out additional tests of the AI systems for which a Union technical documentation assessment certificate was issued. §