In Force Checked October 24, 2026
Each product law sets its own route to CE marking; the general rules come from Regulation (EC) 765/2008 and Decision 768/2008/EC.
What It Covers
The marking a manufacturer affixes to show that a product meets every applicable EU product law, and the technical file and declaration of conformity behind it.
Who It Applies To
Manufacturers of products covered by EU harmonization legislation such as machinery, toys, electrical equipment and medical devices, and importers who must check the manufacturer has done so.
Key Requirements
- Identify every EU law that applies to the product, not only the obvious one.
- Follow each law’s conformity assessment route, using a notified body where required.
- Compile the technical documentation and sign the EU declaration of conformity.
- Affix the CE marking, and keep the file available to authorities for the required period.
What an Auditor Asks to See
- The technical file and declaration of conformity, and the list of laws and standards cited.
Where Systems Fall Short
- Declarations of conformity that cite superseded directives or standards.
How QES Helps
Technical file audits that check every applicable law and the editions cited.
Related Standards
Sources. EUR-Lex — Decision No 768/2008/EC (New Legislative Framework) (opens in a new tab); EUR-Lex — Regulation (EC) No 765/2008 (opens in a new tab). Status checked October 24, 2026. This page summarizes CE Marking; it does not reproduce or replace it. Buy the standard from its publisher, or read the regulation in its official text, before relying on a detail. Not legal advice.