Glossary · AI Act
Notified Body
An independent organisation designated by a member state to perform third-party conformity assessments of certain high-risk AI systems.
Explained in depth: AI Act overview
Notified bodies are the EU's established mechanism for independent product certification, familiar from medical devices and machinery. Under the AI Act, their involvement is required in a narrower set of cases: certain biometric systems where harmonised standards are not fully applied, and high-risk AI embedded in products whose sector rules already mandate third-party assessment. The notified body examines the provider's quality management system and technical documentation and issues certificates that underpin CE marking. Member states designate and monitor their notified bodies, which must demonstrate independence, competence, and confidentiality safeguards. The Commission maintains the public register (NANDO) of designated bodies and their scopes.
Why it matters
If your high-risk system needs a notified body, capacity is a planning issue: designated bodies with AI Act scope are still few, and assessment slots take time. Determine early whether self-assessment suffices or third-party assessment applies, because the answer changes both timeline and budget.