CE Marking: A Step‑by‑Step Guide for Manufacturers

Navigating CE Certification: A Step-by-Step Guide from Stancer Testing Lab

CE certification is essential for manufacturers seeking access to the European market. The CE mark demonstrates that a product complies with European Union safety, health, and environmental protection requirements.

This guide explains the CE marking process, applicable European directives, technical documentation requirements, and how Stancer Testing Lab supports manufacturers through EMC testing and regulatory approval.

What Is CE Marking?

European Market Access Explained

The CE mark (Conformité Européenne) confirms that a product meets essential EU safety, health, and environmental protection requirements. Products bearing the CE mark may circulate freely within the European Economic Area.

Manufacturers or authorised representatives affix the mark and assume full responsibility for compliance with applicable European directives.

Why CE Marking Is Mandatory

Legal Requirement for EU Sales

Most electrical and electronic products sold in the EU must bear the CE mark. Non-compliance can lead to customs detention, fines, or product recalls.

Key directives include:

• Low Voltage Directive (2014/35/EU)

• EMC Directive (2014/30/EU)

• Radio Equipment Directive (2014/53/EU)

• RoHS Directive (2011/65/EU)

• Machinery, Medical Devices, ATEX, and ErP Directives

Step-by-Step CE Certification Process

1. Verify Applicability

Identifying Relevant Directives

Determine whether your product falls within the scope of CE-marking directives such as LVD, EMC, or RED. Products outside the scope may require other regulatory approvals but will not bear the CE mark.

2. Evaluate Product Conformity

Design Review and Risk Assessment

Collect information on the product’s design, manufacturing location, serial numbers, and variants. Identify applicable harmonised standards and conduct a formal risk analysis.

3. Determine the Need for a Notified Body

Third-Party Assessment

Low-risk products may be self-declared by the manufacturer. High-risk devices or those lacking harmonised standards require a Notified Body to perform conformity assessment.

4. Conduct Required Testing

Demonstrating Compliance

Products must meet safety, EMC, and radio-performance requirements where applicable. Accredited laboratories perform testing against harmonised European standards and issue compliance reports.

5. Compile the Technical File

Technical Construction Documentation

The technical file includes schematics, materials lists, test reports, sub-assembly descriptions, and applied standards. It must be retained for at least ten years.

6. Draft the Declaration of Conformity

Legal Responsibility Statement

The DoC is a legally binding document stating compliance with all applicable directives and must be translated for each EU market.

7. Affix the CE Mark

Final Compliance Step

After completing documentation, affix the CE mark visibly on the product. If a Notified Body was involved, its identification number must accompany the marking.

Stancer Testing Lab: Your Partner for CE Certification

End-to-End Compliance Support

• EMC and RED testing to EU harmonised standards

• Technical file and Declaration of Conformity support

• Coordination with Notified Bodies

• FCC, ISED, CSA, UKCA market access assistance

Conclusion

CE marking is essential for selling products in Europe. The process involves identifying directives, testing to harmonised standards, preparing documentation, and affixing the CE mark.

Working with Stancer Testing Lab ensures an efficient certification path and confidence in regulatory compliance.

Contact Stancer Testing Lab today to discuss CE certification and EMC testing for your next product.