CE Marking Conformity Readiness Assessment
CE marking is the manufacturer's declaration that a product meets the EU requirements that apply to it. This self-assessment scores how far along you are, so you can see what to fix before shipping to the EU.
1. Have you identified every EU directive or regulation that applies to the product?
For example Low Voltage, EMC, Radio Equipment, Machinery, RoHS.
2. Are harmonised standards chosen and listed for each requirement?
3. Has a risk assessment been completed for the product?
4. Which conformity assessment route applies?
Internal production control or a notified body module.
5. Is test evidence available for EMC and electrical safety?
6. Is the technical file complete and kept up to date?
Design drawings, parts lists, risk assessment, test reports, manuals, labels.
7. Do user instructions and labels meet the language and content rules?
8. Is an EU Declaration of Conformity drafted and signed by an authorised person?
9. Do you have an EU authorised representative and traceability marking if you are outside the EU?
How to use the assessment
Answer each question for one product or product family. Be honest about gaps, since the score is only useful if it reflects real evidence. Read the band result and its recommendations, then assign owners to the lowest scoring areas. Re-run it after each design change or standard update, and export the result to PDF for your quality records.
The method behind CE marking
Under EU product legislation, the manufacturer identifies applicable requirements, applies the conformity assessment procedure, compiles technical documentation, draws up the EU declaration of conformity and affixes the CE mark. Many products self-certify through internal production control. Some categories need a notified body. Using harmonised standards gives a presumption of conformity with the related requirements. Importers and authorised representatives carry their own duties.
Common mistakes
Frequent errors include citing a standard that has been superseded, assuming one directive covers everything, and treating a component's CE mark as the product's. The declaration must name the product, directives and standards correctly and be kept with the file.
- Forgetting that EMC and safety are separate requirements
- Missing RoHS in the declaration where it applies
- Not updating the file after a design change
- Affixing the mark before the declaration is signed
Frequently Asked Questions
Who is responsible for CE marking?
The manufacturer is responsible. If the manufacturer is outside the EU, an authorised representative or the importer has defined duties. Distributors must check that the mark and documents are present before supplying the product.
Is CE marking a quality or safety certificate?
It is not a quality mark. It is the manufacturer's claim of conformity with applicable EU requirements, such as health, safety and environmental protection. It is backed by technical documentation and, for some products, a notified body.
Do I need a notified body?
Not always. Many product groups allow self-declaration through internal production control. Higher risk categories, such as some machinery in Annex IV or certain medical devices, require a notified body. The directive text tells you which route applies.
How long must I keep the technical file?
Typically ten years after the product is placed on the market, though the period can differ by legislation. Keep it available to market surveillance authorities on request and update it when the design changes.
If your technical files and design revisions are spread across PLM, ERP and shared drives, we can help build a private assistant over them for your team.
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