Conformity Assessment
Definition
The procedure by which it is demonstrated that the applicable requirements of European Union product legislation have been fulfilled for a product, carried out through one of the standard assessment modules set out in the relevant legislation.
Expanded Explanation
Decision No 768/2008/EC defines a set of modules, ranging from internal production control by the manufacturer, to type examination and quality assurance procedures involving an independent notified body. Each piece of product legislation states which modules are available for that product, according to the risk involved.
Whichever module applies, the manufacturer must compile technical documentation, draw up a declaration of conformity and, where required, affix the CE marking. Harmonised standards published in the Official Journal give a presumption of conformity: following them is voluntary, but doing so shifts the burden of proof.
Under the Ecodesign for Sustainable Products Regulation, passport related requirements form part of this picture rather than sitting beside it. Where a delegated act requires passport information, its correctness becomes part of what conformity means for that product.
Why It Matters
Passport content and technical documentation must agree. If a declared material composition, efficiency figure or certification reference in the passport differs from the technical file, the inconsistency is itself a compliance finding, and it is visible to anyone who scans the product.
Common Misconceptions
The CE marking is the manufacturer’s own declaration that the product meets applicable EU requirements. Only some product categories require a notified body, and the marking says nothing about quality beyond legal conformity.
Related Terms
Related Knowledge Base Articles
Related Articles
- EU Declaration of Conformity
- Harmonised Standard
- Notified Body
- Presumption of Conformity
- Technical Documentation
- Authorised Representative
- Corrective Action
- Market Surveillance
See Also
References
- Decision No 768/2008/EC on a common framework for the marketing of products: https://eur-lex.europa.eu/eli/dec/2008/768(1)/oj
- European Commission, The Blue Guide on the implementation of EU product rules: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A52022XC0629%2804%29
- Regulation (EU) 2024/1781, Official Journal of the European Union: https://eur-lex.europa.eu/eli/reg/2024/1781/oj
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.