EU AI Chapter III - Article 37: Challenge To The Competence Of Notified Bodies

Oct 13, 2025by Shrinidhi Kulkarni

Introduction 

The rapid advancement of artificial intelligence (AI) technologies necessitates comprehensive regulations to ensure their safe and ethical deployment. The European Union (EU) is at the forefront of establishing a robust legal framework to govern AI systems. One critical component of this framework is Chapter III, Article 37, which addresses the challenge to the competence of notified bodies. This article is pivotal in maintaining the integrity and reliability of AI governance within the EU. Article 37 of the EU AI Regulation is designed to ensure that notified bodies, which play a crucial role in the conformity assessment of AI systems, possess the necessary competence and impartiality. This section provides a structured overview of Article 37, its implications, and its significance in the broader context of AI governance in the EU.

EU AI Chapter III - Article 37: Challenge To The Competence Of Notified Bodies

Understanding Notified Bodies

Definition And Role

  • Notified Bodies: Independent organizations designated by EU member states to assess the conformity of certain products, including AI systems, with applicable regulations.

  • Function: They evaluate whether AI systems meet the required standards for safety, performance, and compliance with EU laws.

Importance In AI Governance

  • Ensuring Compliance: Notified bodies are essential for verifying that AI systems adhere to EU regulations, thereby ensuring public safety and trust.

  • Facilitating Market Access: By certifying AI systems, these bodies enable companies to market their products across the EU.

Article 37: Key Provisions - EU AI Chapter III 

Grounds For Challenge

  • Competence: Stakeholders can challenge the competence of a notified body if there are doubts about its ability to perform conformity assessments accurately.

  • Impartiality: Concerns about a notified body’s impartiality or potential conflicts of interest can also be grounds for challenge.

Process Of Challenge

  • Filing a Complaint: Stakeholders must submit a formal complaint outlining their concerns regarding a notified body’s competence or impartiality.

  • Review Process: The relevant authorities will review the complaint and conduct an investigation to determine the validity of the claims.

Possible Outcomes

  • Withdrawal of Notification: If a notified body is found incompetent or biased, its notification can be withdrawn, meaning it can no longer assess AI systems.

  • Reassessment: The body may undergo reassessment to rectify identified issues and restore its notification status.

Implications For AI Stakeholders - EU AI Chapter III

For AI Developers

  • Compliance Assurance: Developers must ensure their AI systems are assessed by competent notified bodies to avoid regulatory pitfalls.

  • Market Confidence: Certification by a credible notified body enhances market confidence in AI products.

For Notified Bodies

  • Maintaining Standards: Notified bodies must continuously meet high standards of competence and impartiality to retain their status.

  • Operational Transparency: Ensuring transparent operations and decision-making processes to prevent challenges.

Significance Of Article 37 - EU AI Chapter III

Enhancing AI Governance

  • Accountability: Article 37 reinforces accountability within the AI regulatory framework, ensuring that notified bodies are held to stringent standards.

  • Public Trust: By safeguarding the competence and impartiality of notified bodies, the EU enhances public trust in AI systems.

Supporting Innovation

  • Balanced Regulation: While ensuring safety and compliance, the regulation also supports innovation by providing clear guidelines for AI system assessment.

  • Global Leadership: The EU’s proactive approach positions it as a leader in global AI governance.

Challenges And Considerations

Implementation Challenges

  • Resource Allocation: Adequate resources are needed to effectively monitor and assess the competence of notified bodies.

  • Consistency Across Member States: Ensuring uniform application of Article 37 across all EU member states can be challenging.

Future Considerations

  • Evolving Standards: As AI technologies evolve, standards for competence and impartiality will need to be regularly updated.

  • International Collaboration: Collaborating with international bodies to harmonize AI regulations could enhance global AI governance.

Conclusion

Article 37 of the EU AI Regulation plays a critical role in maintaining the integrity of AI governance by ensuring that notified bodies are competent and impartial. This not only safeguards public trust in AI systems but also supports the EU’s vision of becoming a global leader in AI innovation and regulation. As AI technologies continue to evolve, the principles outlined in Article 37 will be instrumental in guiding the ethical and safe deployment of AI systems across the EU.