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Article 34

Subsidiaries of and Subcontracting by Notified Bodies

Updated on Feb 6th 2024 based on the version endorsed by the Coreper I on Feb 2nd

1. Where a notified body subcontracts specific tasks connected with the conformity assessment or has recourse to a subsidiary, it shall ensure that the subcontractor or the subsidiary meets the requirements laid down in Article 33 and shall inform the notifying authority accordingly.

2. Notified bodies shall take full responsibility for the tasks performed by subcontractors or subsidiaries wherever these are established.

3. Activities may be subcontracted or carried out by a subsidiary only with the agreement of the provider. Notified bodies shall make a list of their subsidiaries publicly available.

4. The relevant documents concerning the assessment of the qualifications of the subcontractor or the subsidiary and the work carried out by them under this Regulation shall be kept at the disposal of the notifying authority for a period of 5 years from the termination date of the subcontracting activity.

[Previous version]

1. Where a notified body subcontracts specific tasks connected with the conformity assessment or has recourse to a subsidiary, it shall ensure that the subcontractor or the subsidiary meets the requirements laid down in Article 33 and shall inform the notifying authority accordingly.

2. Notified bodies shall take full responsibility for the tasks performed by subcontractors or subsidiaries wherever these are established.

3. Activities may be subcontracted or carried out by a subsidiary only with the agreement of the provider.

4. The relevant documents concerning the assessment of the qualifications of the subcontractor, or the subsidiary and the work carried out by them under this Regulation shall be kept at the disposal of the notifying authority for a period of 5 years from the termination date of the subcontracting activity.

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