Embedded Files
CE marking indicates that a product complies with EU safety, health, and environmental requirements, allowing it to be legally sold throughout the European Economic Area (EEA), Turkey, and Northern Ireland. It acts as a "passport" for products, declaring manufacturer responsibility for compliance. It is not a quality mark, but a legal, mandatory requirement for specific product categories like toys, electronics, and machinery.
Step‑by‑step CE process
Step‑by‑step CE process
- Check if your product requires CE marking and which rules apply
Determine whether your product falls under one or more EU “New Approach” directives/regulations (e.g. Machinery, LVD, EMC, Toys, Medical Devices).
See: CE marking – Your Europe (europa.eu)
See: Manufacturers – Single market for goods (single-market-economy.ec.europa.eu)
See: Instructions for AI to automate this
- Identify essential requirements and relevant harmonised standards
For each applicable directive/regulation, identify the essential health, safety, performance and environmental requirements, then select relevant harmonised standards to demonstrate presumption of conformity.
See: “Identify the applicable directive(s)/regulation(s) and harmonised standards” on the Manufacturers page (single-market-economy.ec.europa.eu)
See: Instructions for AI to automate this
- Choose the appropriate conformity assessment procedure
Based on the product type, risk level and legislation, select the correct conformity assessment module(s); determine whether you can self‑assess or must involve a notified body.
See: “Conformity assessment procedures” on CE marking – Your Europe (europa.eu)
See: Instructions for AI to automate this
- Involve a notified body if required
If the legislation mandates third‑party assessment (e.g. certain PPE, medical devices, pressure equipment), select a suitable notified body and complete the required testing, audits or certification.
See: “Notified bodies” section on CE marking – Your Europe (europa.eu)
See: Instructions for AI to automate this
- Carry out risk assessment, design controls and testing
Perform and document a risk assessment, implement risk‑reduction measures in design and instructions, and conduct all required tests (in‑house or external) to show compliance with the essential requirements and standards. Note, correct risk assessment is the most important condition for achieving CE compliance. See all CE Risks.
See: “Manufacturers’ responsibilities” on Manufacturers – Single market for goods (single-market-economy.ec.europa.eu)
See: Instructions for AI to automate this
- Compile and maintain technical documentation (technical file)
Prepare a technical file covering design, manufacture and operation of the product (drawings, BOM, test reports, risk assessment, instructions, labels, quality controls, etc.) and keep it available for market surveillance authorities for the required retention period.
See: “Technical documentation” on CE marking – Your Europe (europa.eu)
EU and practical guidance of how Technical File should look like:
The European Commission’s Preparing Technical Documentation page defines mandatory sections
Minimum components to be included:
Product description and identification
Design and manufacturing information (drawings, schematics, BOM)
Applicable EU legislation and standards
Risk assessment and test reports
Instructions and labelling
Copy of EU Declaration of Conformity
Directive Annex Structure Examples in Machinery Regulation EU 2023/1230 Annex VII:
General description of the machinery
Design, manufacture and operation drawings
Risk assessment documentation
Standards applied
Copy of instructions and DoC
See: Instructions for AI to automate this
- Draft and sign the EU Declaration of Conformity (DoC)
Draw up the EU Declaration of Conformity stating that the product meets all applicable EU legislation; ensure it is signed by the manufacturer or authorised representative and accompanies the product as required.
See: “EU Declaration of Conformity” on CE marking – Your Europe (europa.eu)
See: Instructions for AI to automate this
- Affix the CE marking correctly to the product
Affix the CE mark visibly, legibly and indelibly to the product (or its data plate/packaging where allowed), following the size and proportion rules; add any required notified body number.
See: “Affixing the CE marking” on CE marking – Your Europe (europa.eu)
See: Instructions for AI to automate this
- Ensure ongoing compliance and post‑market surveillance
Monitor product performance, handle complaints and incidents, take corrective actions (including recalls) where necessary, and update documentation if design or legislation changes.
See: “Obligations of manufacturers” on Manufacturers – Single market for goods (single-market-economy.ec.europa.eu)
See: Instructions for AI to automate this
- Cross‑document consistency checking (high‑value AI use)
Ensure risk assessment, standards, technical file, and DoC are internally consistent.
See: “Obligations of manufacturers” on Manufacturers – Single market for goods (single-market-economy.ec.europa.eu)
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