Providers must lodge an application with a notified body of their choice for the assessment of the technical documentation relating to the AI system.
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 e
Providers must include the name and address of the provider in the application.
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 e
Providers must include a written declaration that the same application has not been lodged with any other notified body in the application.
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 e
Providers must include the technical documentation referred to in Annex IV in the application.
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 e
Notified bodies must examine the technical documentation.
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 e
Notified bodies must grant full access to the training, validation, and testing data sets used, where relevant.
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 e
Notified bodies must require the provider to supply further evidence or carry out further tests, if necessary.
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 e
Notified bodies must carry out adequate tests, if necessary.
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 e
Notified bodies must grant access to the training and trained models of the AI system, including its relevant parameters, upon a reasoned request.
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 e
Notified bodies must notify the provider or its authorised representative of the decision.
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 e
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