AI Dictionary › Regulation
Organismo notificato
A notified body is the independent, accredited entity, formally designated by an EU member state, authorized to carry out the third-party conformity assessments required for certain categories of high-risk AI systems. The term "notified" reflects the fact that the member state has officially communicated to the European Commission and other member states the existence and competence of that body, making it recognized throughout the Union.
To obtain this status, the body must demonstrate specific technical competence, independence from the providers it assesses, and compliance with organizational and procedural requirements set by the regulation. Once accredited, it can examine an AI system's technical documentation, conduct or oversee additional testing, and issue the conformity certificate needed to affix the CE mark to certain high-risk systems.
For companies whose systems require third-party assessment, identifying the notified body competent for their sector and planning interaction with it well in advance is a critical step on the path to commercialization: assessment timelines can be significant and must be factored into product launch planning.
The notified body system is an infrastructure already well established in European product regulation, used for decades for medical devices, machinery and other high-risk products, and has been extended to the assessment of AI systems following the same independent external verification model.
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