We previously covered "what CE certification actually is," explaining the relationship between the mark, the declaration, and testing. This article goes a level deeper, covering the complete operational process for CE certification in practice.
Step 1: Determine Which EU Directives Apply
The CE mark itself isn't a single standard — it's a "marking system" representing whichever specific EU directives apply to the product. The same product type may fall under multiple directives at once — for example, a wireless-enabled electronic toy might simultaneously involve the Toy Safety Directive, the Radio Equipment Directive (RED), the EMC Directive, and even RoHS. This first determination step directly decides which tests need to be done afterward — getting it wrong leads to an incomplete testing scope later.
Step 2: Determine the Compliance Path
Different directives allow different conformity assessment paths, commonly including:
- Manufacturer's self-declaration: applies to relatively lower-risk products — the manufacturer completes the technical file and issues the declaration of conformity themselves, without a mandatory third-party body, though a third-party test report is typically still needed as the technical basis
- Third-party body assessment: applies to higher-risk product categories, requiring a "Notified Body" to participate in the assessment or issue a certificate
Step 3: Prepare the Technical File
This is an often-underestimated part of CE certification. The technical file needs to include the product description, list of applicable directives, design drawings, risk assessment, test reports, and instructions for use. This file doesn't need to be submitted to an EU official body, but must be available on request from market surveillance authorities — typically required to be retained for at least 10 years.
Step 4: Complete Testing and Issue the Declaration of Conformity (DoC)
Based on the test results, the manufacturer needs to issue an EU Declaration of Conformity — a legally valid formal document declaring the product meets all applicable directives. The declaration needs to include specific content like manufacturer information, product model, the list of applicable directives, and the reference numbers of the harmonized standards relied upon.
Step 5: Affix the CE Mark
The mark itself has fixed shape and proportion requirements and can't be freely resized or distorted. It's typically required to be affixed to the product itself (or on the packaging/accompanying documents where that isn't feasible). This step seems simple but commonly runs into detail issues like "incorrect mark proportions" or "non-compliant placement."
Common Process Mistakes
- Skipping the directive determination step and directly copying the test scope from a similar product, missing an applicable directive
- Incomplete technical file preparation, unable to provide complete materials promptly if a market surveillance authority spot-checks
- Non-standard declaration of conformity content, missing applicable directives or standard reference numbers
Frequently Asked Questions
Q: Does CE certification need to be submitted to an EU body for approval? A: In most cases, no — CE certification is fundamentally a self-declaration system, with companies completing the assessment process themselves and keeping the technical file available on request. Higher-risk product categories may require a Notified Body's involvement.
Q: Can I write the declaration of conformity myself? A: Yes, but the content needs to be accurate and standardized — best drafted based on the test report and applicable directive list, to avoid omitting key information that would render the declaration legally invalid.
If you're unsure which EU directives apply to your product, send us your product details and we can help with an initial determination.