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Article 45

Information obligations of notified bodies

https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32024R1689#art_45 ↗
Notified Bodies

Notified bodies must inform the other notified bodies of quality management system approvals which they have refused, suspended or withdrawn.

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2. Each notified body shall inform the other notified bodies of:

(a)
quality management system approvals which it has refused, suspended or withdrawn, and, upon request, of quality system approvals which it has issued;
(b)
Union technical documentation assessment certificates or any supplements thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, of the certificates and/or supplements thereto which it has issued.
3. Each notified body shall provide the other notified bodies carrying out similar conformity assessment activities covering the same types of AI systems with relevant information on issues relating to negative and, on request, positive conformity assessment results.

4. Notified bodies shall safeguard the confidentiality of the information that they obtain, in accordance with Article 78.
Notified Bodies

Notified bodies must inform the other notified bodies of Union technical documentation assessment certificates or any supplements thereto which they have refused, withdrawn, suspended or otherwise restricted.

Show source text
2. Each notified body shall inform the other notified bodies of:

(a)
quality management system approvals which it has refused, suspended or withdrawn, and, upon request, of quality system approvals which it has issued;
(b)
Union technical documentation assessment certificates or any supplements thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, of the certificates and/or supplements thereto which it has issued.
3. Each notified body shall provide the other notified bodies carrying out similar conformity assessment activities covering the same types of AI systems with relevant information on issues relating to negative and, on request, positive conformity assessment results.

4. Notified bodies shall safeguard the confidentiality of the information that they obtain, in accordance with Article 78.
Notified Bodies

Notified bodies must provide the other notified bodies carrying out similar conformity assessment activities covering the same types of AI systems with relevant information on issues relating to negative and, on request, positive conformity assessment results.

Show source text
2. Each notified body shall inform the other notified bodies of:

(a)
quality management system approvals which it has refused, suspended or withdrawn, and, upon request, of quality system approvals which it has issued;
(b)
Union technical documentation assessment certificates or any supplements thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, of the certificates and/or supplements thereto which it has issued.
3. Each notified body shall provide the other notified bodies carrying out similar conformity assessment activities covering the same types of AI systems with relevant information on issues relating to negative and, on request, positive conformity assessment results.

4. Notified bodies shall safeguard the confidentiality of the information that they obtain, in accordance with Article 78.
Notified Bodies

Notified bodies must safeguard the confidentiality of the information that they obtain.

Show source text
2. Each notified body shall inform the other notified bodies of:

(a)
quality management system approvals which it has refused, suspended or withdrawn, and, upon request, of quality system approvals which it has issued;
(b)
Union technical documentation assessment certificates or any supplements thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, of the certificates and/or supplements thereto which it has issued.
3. Each notified body shall provide the other notified bodies carrying out similar conformity assessment activities covering the same types of AI systems with relevant information on issues relating to negative and, on request, positive conformity assessment results.

4. Notified bodies shall safeguard the confidentiality of the information that they obtain, in accordance with Article 78.

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