Notified Body
Definition
A notified body is a conformity assessment body that a Member State has designated and notified to the European Commission as competent to carry out third-party conformity assessment tasks under a specific piece of Union harmonisation legislation.
Expanded Explanation
Notified bodies are private or public organisations assessed against competence, impartiality and capability criteria, then designated for a defined scope. They are listed in the Commission’s NANDO database with the legislation and product ranges they cover, and each carries a four-digit identification number.
Whether a notified body is involved at all depends on the conformity assessment module that the applicable legislation prescribes. Many modules are internal production control, where the manufacturer assesses conformity itself; others require type examination or quality system approval by a third party. Under the current ESPR framework, the assessment route for a given product group is set by the applicable delegated act rather than by the framework regulation.
Why It Matters
Involving a notified body changes lead times, cost and the documentary trail. Assuming third-party assessment where none is required wastes budget; assuming self-assessment where a module requires a notified body invalidates the declaration.
Legal and Regulatory Context
Regulation (EU) 2024/1781, Chapter X on notification of conformity assessment bodies, and Decision No 768/2008/EC for the underlying module framework.
Relationship to Adjacent Concepts
A notified body performs conformity assessment before placing on the market. A market surveillance authority acts afterwards. Neither issues the EU declaration of conformity.
Common Misconceptions
Most have not. Where a notified body is involved its identification number appears alongside the CE marking; where the module is internal production control, no number appears.
Related Terms
- Conformity Assessment
- EU Declaration of Conformity
- Technical Documentation
- Harmonised Standard
- Market Surveillance Authority
Related Knowledge Base Articles
- How Conformity Assessment Works for Digital Product Passports
- How Will Digital Product Passports Change Product Compliance?
Related Articles
- Conformity Assessment
- EU Declaration of Conformity
- Harmonised Standard
- Presumption of Conformity
- Technical Documentation
- Authorised Representative
- Corrective Action
- Market Surveillance
See Also
References
- Regulation (EU) 2024/1781, Chapter X: https://eur-lex.europa.eu/eli/reg/2024/1781/oj
- Decision No 768/2008/EC on a common framework for the marketing of products: https://eur-lex.europa.eu/eli/dec/2008/768/oj
- European Commission, NANDO information system for notified bodies: https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies
About This Article
tieback Knowledge is a continuously maintained reference library covering Digital Product Passports, product traceability, product compliance and related regulations. Articles are reviewed regularly as legislation, standards and implementation guidance evolve.