Art.37
EU AI Act Guide › Chapter III — High-Risk AI Systems › Article 37

Article 37 — Challenge to the Competence of Notified Bodies

Governance SME Relevant ~2 min read · 469 words

Article 37 gives the European Commission the power to investigate notified bodies it has reason to doubt. If a notified body appears to be incompetent or failing to meet its obligations, the Commission can step in — ultimately forcing the member state to act or taking unilateral action to suspend or restrict the body’s designation.

✓ Low compliance impact for SMEs

WHAT THE ARTICLE IS ABOUT

The Commission’s investigative power over underperforming notified bodies

Article 37 establishes an oversight mechanism at EU level for the notified body system. While member states designate and monitor notified bodies under Articles 28–36, the Commission retains the power to investigate and challenge any notified body it believes is not meeting the required standards — creating a second layer of quality assurance above national oversight.

WHAT IT SAYS

Commission investigates, member state must act, Commission can override

  • Where the Commission has reason to doubt the competence of a notified body, it must investigate — including reviewing the evidence on which the designation was based
  • The Commission may request the relevant member state to provide all information relating to the notification and the body’s ongoing compliance
  • Where investigation reveals the body does not meet the Article 31 requirements, the Commission requests the member state to take corrective action — up to and including withdrawal of the designation
  • If the member state fails to take the requested action within the specified timeframe, the Commission itself may suspend, restrict or withdraw the body’s designation through an implementing act
  • During the investigation period, the Commission may suspend the body’s activities as a precautionary measure
  • The Commission keeps other member states and the Council informed of investigation proceedings and outcomes

WHO IS AFFECTED

Notified bodies under investigation and providers relying on their certificates

  • Notified bodies that are the subject of a Commission investigation
  • Member states whose designations are being challenged at EU level
  • Providers with ongoing assessments or certificates issued by a body under investigation
  • The Commission acting in its EU-level oversight capacity
  • Other member states and the Council informed of proceedings

WHAT IT MEANS FOR SMES

A quality assurance backstop — but monitor proceedings proactively

  • For most SMEs this article operates invisibly in the background — the Commission’s oversight role exists to maintain the integrity of the system you rely on
  • However: if your notified body becomes the subject of a Commission investigation, this is public information that will appear in NANDO and EU Official Journal notices — set up alerts for your notified body’s name
  • A Commission investigation does not automatically invalidate your certificate — but it is a serious signal that warrants legal advice on your specific situation
  • The ultimate protection this article provides is systemic: the existence of Commission oversight powers creates strong incentives for notified bodies to maintain their standards continuously
  • If you have concerns about the quality of an assessment you received, Article 37 represents the escalation path — concerns can be raised with your national notifying authority, which the Commission monitors

Related Articles

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