Conformity Body Notification

Legal Framework

Conformity body notification under the AI Act is governed primarily by Articles 29 and 30, which establish the procedural mechanism through which conformity assessment bodies obtain official status to evaluate high-risk AI systems before market placement. Article 29 sets out the application requirements: a conformity assessment body must submit an application to the notifying authority of the Member State in which it is established, demonstrating compliance with the requirements laid down in Articles 31 through 36. These requirements cover independence, competence, staff qualifications, impartiality, and the body's internal organisation and quality management system.

Article 30 governs the notification procedure itself. Once the notifying authority verifies that the applicant body meets the applicable requirements, the Member State notifies the European Commission and the other Member States. The notification must include details of the conformity assessment activities, the AI system categories covered, relevant harmonisation standards applied, and any national accreditation certificate issued. Where a notification is based on national accreditation, presumptions of competence apply. Where accreditation is not used, the notifying authority must provide the Commission with documentary evidence demonstrating the body's competence and arrangements for regular monitoring.

Article 85 complements this framework by granting any natural or legal person the right to lodge complaints with the relevant market surveillance authority where they consider that AI Act provisions have been infringed, linking the notification regime to downstream enforcement under Regulation (EU) 2019/1020.

Key Developments

The AI Act's conformity body notification regime draws directly on the established New Legislative Framework model used across EU product safety law, meaning that existing jurisprudence and Commission implementing decisions under that framework provide interpretive guidance. The Court of Justice has repeatedly affirmed that notified bodies operate within a system of shared competence between national authorities and EU institutions, and that notification decisions must be reasoned and subject to judicial review under national law.

A critical structural feature is the distinction between accreditation-based and non-accreditation-based notifications. Where accreditation is used, the notifying authority's discretion is significantly constrained, as accreditation certificates issued under Regulation (EC) 765/2008 carry binding evidentiary weight. This creates a practical threshold: bodies seeking notification without prior accreditation face a substantially heavier documentary burden and greater scrutiny of their competence demonstrating.

The notification is not self-executing. The Commission and Member States may raise objections, particularly where concerns exist about the body's independence or technical capacity. The standing of notified bodies is also subject to periodic reassessment, and notifications can be restricted, suspended, or withdrawn where competence conditions are no longer met.

Practical Guidance

• Verify accreditation status before submitting an Article 29 application. Bodies holding valid accreditation under Regulation (EC) 765/2008 benefit from a presumption of competence that materially reduces the notification timeline and documentary burden under Article 30.
• Prepare a comprehensive conformity assessment scope definition. The notification must specify the categories of AI systems and conformity assessment modules the body intends to cover, and subsequent expansion requires a new or amended notification.
• Document the quality management system against Articles 33 and 34 requirements before application. Notifying authorities will scrutinise internal procedures, conflict-of-interest safeguards, and staff competence records as part of the initial assessment.
• Establish procedures for ongoing compliance monitoring. Notifying authorities are required to conduct regular surveillance of notified bodies, and deficiencies identified during monitoring can trigger restriction or withdrawal of notification status.
• Map complaint exposure under Article 85. Since market surveillance authorities must handle complaints about AI Act infringements, notified bodies should implement internal mechanisms to address complaints that may be escalated to these authorities, including documentation of assessment decisions and rationale.