// GLOSSARY
Notified Body
A notified body is an organisation designated by an EU Member State to carry out third-party conformity assessment for products subject to EU legislation. Notified bodies assess whether products meet the applicable requirements before manufacturers can affix the CE marking and place products on the EU market.
Truth Anchor: This definition is based on Regulation (EU) 2024/1781 (ESPR) and related EU legislation. Source: EUR-Lex CELEX:32024R1781
Role in ESPR Compliance
Under ESPR, notified bodies may be required to carry out third-party conformity assessment for specific product categories where the delegated act requires it. For most ESPR products, manufacturers can self-declare conformity under Module A (internal production control). However, for products with higher environmental risk or where the delegated act specifies third-party assessment, a notified body must be involved.
How to Find a Notified Body
The European Commission maintains the NANDO (New Approach Notified and Designated Organisations) database, which lists all notified bodies designated by EU Member States. Manufacturers can search the NANDO database by product category and country to find a notified body for their specific product. The NANDO database is available at ec.europa.eu/growth/tools-databases/nando/.
Notified Body Scope
Each notified body is designated for a specific scope of products and conformity assessment procedures. Manufacturers must use a notified body whose scope covers their product category and the required conformity assessment procedure. Using a notified body outside its designated scope invalidates the conformity assessment.
Costs and Timelines
Notified body assessment costs vary significantly depending on the product category, the complexity of the assessment, and the notified body. Manufacturers should budget 3–6 months for notified body assessment and factor this into their compliance timelines. Early engagement with a notified body is recommended to ensure availability and to identify any issues that may delay certification.
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Notified Body Designation and Accreditation
A notified body is a conformity assessment body that has been designated by a national authority in an EU member state to conduct third-party conformity assessments under EU product legislation. The designation process requires the conformity assessment body to demonstrate its technical competence, impartiality, and operational independence through accreditation by a national accreditation body (such as UKAS in the UK, DAkkS in Germany, or COFRAC in France). The accreditation is based on ISO/IEC 17065 (Conformity assessment — requirements for bodies certifying products, processes, and services) for product certification bodies, or ISO/IEC 17020 (Conformity assessment — requirements for the operation of various types of bodies performing inspection) for inspection bodies. Once designated, the notified body is assigned a four-digit identification number and listed in the NANDO database.
Notified Body Obligations Under ESPR
Notified bodies that conduct conformity assessments under ESPR have specific obligations: they must conduct assessments impartially and without conflicts of interest, they must maintain the technical competence needed to assess the product categories for which they are designated, they must keep records of all conformity assessments conducted, they must cooperate with market surveillance authorities and provide them with information on request, and they must report to the designating national authority any cases where they have reason to believe that a manufacturer has provided false information or has not corrected non-conformities. Notified bodies are subject to regular surveillance by the national accreditation body to verify that they continue to meet the designation requirements.