Annex VII

Conformity based on an assessment of the quality management system and an assessment of the technical documentation is the conformity assessment procedure based on points 2 to 5.
The approved quality management system for the design, development and testing of AI systems pursuant to Article 17 shall be examined in accordance with point 3 and shall be subject to surveillance as specified in point 5. The technical documentation of the AI system shall be examined in accordance with point 4.
3.1.
(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 decision shall be notified to the provider or its authorised representative.
The notification shall contain the conclusions of the assessment of the quality management system and the reasoned assessment decision.
3.3.
3.4.
The proposed changes shall be examined by the notified body, which shall decide whether the modified quality management system continues to satisfy the requirements referred to in point 3.2 or whether a reassessment is necessary.
The notified body shall notify the provider of its decision. The notification shall contain the conclusions of the examination of the changes and the reasoned assessment decision.
4.1.
4.2.
(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.
4.4.
4.5.
4.6.
Where the AI system is in conformity with the requirements set out in Chapter III, Section 2, the notified body shall issue a Union technical documentation assessment certificate. The certificate shall indicate the name and address of the provider, the conclusions of the examination, the conditions (if any) for its validity and the data necessary for the identification of the AI system.
The certificate and its annexes shall contain all relevant information to allow the conformity of the AI system to be evaluated, and to allow for control of the AI system while in use, where applicable.
Where the AI system is not in conformity with the requirements set out in Chapter III, Section 2, the notified body shall refuse to issue a Union technical documentation assessment certificate and shall inform the applicant accordingly, giving detailed reasons for its refusal.
Where the AI system does not meet the requirement relating to the data used to train it, re-training of the AI system will be needed prior to the application for a new conformity assessment. In this case, the reasoned assessment decision of the notified body refusing to issue the Union technical documentation assessment certificate shall contain specific considerations on the quality data used to train the AI system, in particular on the reasons for non-compliance.
4.7.
5.1.
5.2.
5.3.
3.1. (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.
(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 decision shall be notified to the provider or its authorised representative. The notification shall contain the conclusions of the assessment of the quality management system and the reasoned assessment decision.
3.3.
3.4. The proposed changes shall be examined by the notified body, which shall decide whether the modified quality management system continues to satisfy the requirements referred to in point 3.2 or whether a reassessment is necessary. The notified body shall notify the provider of its decision. The notification shall contain the conclusions of the examination of the changes and the reasoned assessment decision.
4.1.
4.2. (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.
(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.
4.4.
4.5.
4.6. Where the AI system is in conformity with the requirements set out in Chapter III, Section 2, the notified body shall issue a Union technical documentation assessment certificate. The certificate shall indicate the name and address of the provider, the conclusions of the examination, the conditions (if any) for its validity and the data necessary for the identification of the AI system. The certificate and its annexes shall contain all relevant information to allow the conformity of the AI system to be evaluated, and to allow for control of the AI system while in use, where applicable. Where the AI system is not in conformity with the requirements set out in Chapter III, Section 2, the notified body shall refuse to issue a Union technical documentation assessment certificate and shall inform the applicant accordingly, giving detailed reasons for its refusal. Where the AI system does not meet the requirement relating to the data used to train it, re-training of the AI system will be needed prior to the application for a new conformity assessment. In this case, the reasoned assessment decision of the notified body refusing to issue the Union technical documentation assessment certificate shall contain specific considerations on the quality data used to train the AI system, in particular on the reasons for non-compliance.
4.7.
5.1.
5.2.
5.3.