Notified Body
Independent organization designated to assess conformity of certain high-risk AI systems.
How the laws define this
National frameworks and European Union regulations consistently define a notified body as an authorized independent or third-party entity designated by national authorities to conduct conformity assessments—such as auditing technical documentation, testing, inspection, and issuing certificates—to verify compliance before market entry. While most sources, including Regulation (EU) 2024/1689 (which applies in Estonia as EU regulation) and Zákon č. 318/2025 Z. z., limit these assessment duties strictly to high-risk AI systems, Regulation (EU) 2023/1230 on machinery applies the mandate to high-risk machinery products. The definitions also diverge regarding organizational classification and specific designating entities: the Amendments to the Law on Information Society Services explicitly allows public, private, or academic bodies and names the Innovation Agency as the national notifying authority, whereas the Law of 20 December 2024 specifically requires an accredited third-party organisation operating under statutory confidentiality and procedural standards set by a general notifying authority.
Synthesised from the 8 statutory definitions below. Each one is quoted in full, with its source.
How jurisdictions differ
What is distinctive in each definition, binding law in force first. Showing 7 of the 8 instruments that define this term; all are listed under Definitions below.
| Jurisdiction | Instrument | Status | What is distinctive |
|---|---|---|---|
| European Union | Regulation (EU) 2023/1230 of the European Parliament and of the Council of 14 June 2023 on machinery and repealing Directive 2006/42/EC of the European Parliament and of the Council and Council Directive 73/361/EEC | In Force | Limits notified bodies to machinery products under the EU Machinery Regulation, requiring mandatory third-party assessment for certain high-risk machinery. |
| Lithuania | Amendments to the Law on Information Society Services (measures to implement EU AI Act / accelerate AI development) | In Force | Specifies public, private or academic conformity assessment bodies notified by Lithuania's Innovation Agency with harmonised procedures and public registry requirements. |
| Slovakia | Act No. 318/2025 Coll., amending and supplementing Act No. 56/2018 Coll. on product conformity assessment (EU AI Act adaptation) | In Force | Adds verification of safety, ethical, and technical standards for high-risk AI systems before market placement by Slovakia's national authorities. |
| Luxembourg | Law of 20 December 2024 on implementing rules and penalties related to the EU Artificial Intelligence Act | Under Review | Requires accreditation, supervision by notifying authority, and compliance with procedural and confidentiality standards under Luxembourg's implementing rules. |
| Cyprus | Governance Framework for the Implementation of Regulation (EU) 2024/1689 on Artificial Intelligence in Cyprus | Adopted | Defines designation under Cyprus's non-binding national framework for ex ante checks and issuing conformity certifications. |
| Lithuania | Amendments to the Law on Technology and Innovation | In Force | Emphasizes authorisation by Lithuania's Innovation Agency for certification, national technical evaluation, and proposal to EU conformity assessment network. |
| Lithuania | AI Regulatory Sandbox Policy | Adopted | Describes coordination by competent authority in Lithuania's non-binding AI Regulatory Sandbox to align assessments with EU acts for market access. |
What it triggers
- Under Regulation (EU) 2023/1230, third-party assessment by a Notified Body is mandatory for certain high-risk machinery.source
- In Lithuania, the Innovation Agency designates notified bodies to carry out conformity assessments of high-risk AI systems.sourcesource
- In Slovakia, notified bodies verify that high-risk AI systems meet required safety, ethical, and technical standards before being placed on the market.source
Definitions (8)
A body designated under national procedures and notified to the Commission to carry out conformity assessment activities for high-risk AI systems, including auditing technical documentation and issuing certificates where required; notified bodies operate under oversight of notifying authorities.
An organisation formally designated under the national framework to carry out conformity‑assessment procedures (including ex ante checks) for high‑risk AI systems and to issue conformity certifications in accordance with the AI Act and national implementing measures.
An entity authorized to carry out conformity assessment of high‑risk AI systems, whose involvement may be coordinated by the competent authority and which aligns assessment practices with EU delegated and implementing acts to support market access.
A conformity assessment body (public, private or academic) that has been assessed, designated, and notified by the national notifying authority (Innovation Agency) to carry out conformity assessments of high-risk AI systems in accordance with harmonised procedures and public registry requirements.
An organisation authorised by the national notifying authority (the Innovation Agency) to perform conformity assessment and certification activities for high‑risk AI systems in accordance with EU AI Act procedures. Notified bodies are evaluated under national technical procedures and may be proposed for notification into the EU conformity assessment network.
An accredited third‑party conformity assessment organisation authorised by the notifying authority to perform conformity assessments and issue attestations for high‑risk AI systems in accordance with the AI Act and national implementing rules. Notified bodies are supervised by the notifying authority and must meet accreditation, procedural and confidentiality standards set out in the implementing framework.
A Notified Body is an independent third-party organization designated by a Member State to carry out conformity assessment tasks, such as testing, inspection, and certification, for products falling under specific EU legislation. For certain high-risk machinery under the EU Machinery Regulation, third-party assessment by a Notified Body is mandatory.
Notified bodies are independent third-party organizations designated by national authorities to carry out conformity assessment tasks for high-risk AI systems. Their role is to verify that these systems meet the required safety, ethical, and technical standards before being placed on the market.
Not to be confused with
Conformity assessment is the process verified by notified bodies, while notified body is the designated organization performing that verification for high-risk AI systems.
High-risk AI system is the AI posing significant risks that requires assessment by a notified body, not the assessing organization itself.
CE marking is the conformity mark resulting from successful assessment, while notified body conducts the assessment leading to it.
Questions and answers
What designates a notified body in Lithuania?
In Lithuania, the Innovation Agency as national notifying authority assesses, designates, and notifies conformity assessment bodies for high-risk AI systems. This applies under amendments to the Law on Information Society Services and Law on Technology and Innovation.
Is notified body assessment mandatory for high-risk AI?
Under Regulation (EU) 2023/1230, it is mandatory for certain high-risk machinery. For high-risk AI systems, designated notified bodies carry out conformity assessments as specified in national laws like Slovakia's Act No. 318/2025 Coll.
What supervision applies to notified bodies?
In Luxembourg, notified bodies are supervised by the notifying authority and must meet accreditation, procedural, and confidentiality standards. Other definitions mention oversight by national authorities.
Related Terms
Conformity Assessment
Process to verify that high-risk AI systems meet regulatory requirements before market placement....
High-Risk AI System
AI systems that pose significant risks to health, safety, or fundamental rights....
CE Marking
Conformity mark indicating AI system compliance with EU requirements....