Article 37: Challenge to the Competence of Notified Bodies
Note: This date is an estimate based on the expected date of entry into force. See here for a full implementation timeline.
The EU Commission will investigate any doubts about the abilities or qualifications of notified bodies (organizations that assess the conformity of certain products before they are sold in the EU). If the Commission finds that a notified body doesn't meet the necessary requirements, it will ask the relevant EU country to fix the issue, which could include suspending or withdrawing the body's notification. If the country doesn't take action, the Commission can suspend, restrict, or withdraw the body's designation. All sensitive information gathered during these investigations will be kept confidential.
Generated by CLaiRK, edited by us.
NOTE: This translation is a machine-generated translation. It is not the official translation provided by the European Parliament. When the AI Act is published in the official journal, the machine-generated translations will be replaced by the official translations.
1. The Commission shall, where necessary, investigate all cases where there are reasons to doubt the competence of a notified body or the continued fulfilment by a notified body of the requirements laid down in Article 31 and of its applicable responsibilities.
2. The notifying authority shall provide the Commission, on request, with all relevant information relating to the notification or the maintenance of the competence of the notified body concerned.
3. The Commission shall ensure that all sensitive information obtained in the course of its investigations pursuant to this Article is treated confidentially in accordance with Article 78.
4. Where the Commission ascertains that a notified body does not meet or no longer meets the requirements for its notification, it shall inform the notifying Member State accordingly and request it to take the necessary corrective measures, including the suspension or withdrawal of the notification if necessary. Where the Member State fails to take the necessary corrective measures, the Commission may, by means of an implementing act, suspend, restrict or withdraw the designation. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 98(2).
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The text used in this tool is the ‘Artificial Intelligence Act, Corrigendum, 19 April 2024’. Interinstitutional File: 2021/0106(COD)