CE Marking Documentation – Simple Guide

CE marking requires manufacturers to maintain certain documents to show that their products meet the applicable EU requirements. The exact documents depend on the laws that apply to the specific product, but the general requirements are as follows.

1. Declaration of Conformity

The Declaration of Conformity (DoC) is a formal document in which the manufacturer declares that the product meets all applicable EU requirements.

It generally includes:

• A unique identification of the product.

• The manufacturer's name and address.

• Details of the authorised representative, if applicable.

• A statement confirming that the manufacturer takes full responsibility for the declaration.

• Product identification details for traceability, which may include a photograph.

• The EU legislation that the product complies with.

• The harmonised standards or other technical specifications used, including their relevant versions.

• Details of the notified body, including its identification number and certificate, where applicable.

• Any additional information required by the applicable legislation.

• Place and date of issue.

• Name, position and signature of the authorised person.

The Declaration of Conformity must be kept up to date and translated into the languages required in the EU countries where the product is sold.

2. Technical Documentation

The technical documentation, often called the technical file, is maintained by the manufacturer and must be provided to authorities if requested.

It generally contains:

• A general description of the product.

• Product design and manufacturing drawings.

• Schematics of components and electrical circuits, where applicable.

• Explanations needed to understand the drawings and design.

• A list of harmonised standards used, either fully or partially.

• Details of alternative solutions used when harmonised standards were not followed.

• Product risk assessment.

• Results of design calculations, inspections and testing.

• Test reports.

• User instructions and safety information.

• Notified body certificates and reports, where applicable.

• Details of how conformity will be maintained during series production.

3. Document Retention

The Declaration of Conformity and technical documentation must be kept for the period specified by the applicable EU legislation after the last product has been placed on the market.

Companies should clearly define:

• Who is responsible for maintaining the documents.

• Where the documents are stored.

• How documents will be protected from loss.

• How records will remain accessible when employees leave or systems are changed.

Losing or being unable to retrieve the technical file can create a serious compliance problem.

4. Instructions and Safety Information

Products must be supplied with the required instructions and safety information.

These instructions must be available in a language that users can easily understand in the EU country where the product is sold.

Providing documentation only in English may not be sufficient. Translation requirements are an important part of product compliance, especially when the information relates to safety.

5. CE Marking Requirements

The CE mark itself must follow specific rules relating to:

• Shape and design.

• Minimum size.

• Correct proportions when enlarged or reduced.

• Visibility and readability.

• Permanence.

• Correct placement on the product.

If a notified body is involved in the relevant production-control process, its identification number must appear with the CE marking where required.

Other markings required by specific EU legislation must also be applied correctly. Markings that could be confused with the CE mark may also be restricted.

6. Practical Compliance Tips

Keep standards updated

Maintain a dated list of the standards used. Standards can be revised, so referring to an outdated version may raise compliance questions.

Cover all product variants

If one Declaration of Conformity covers several models or product variants, the technical documentation should clearly explain why the same assessment applies to all of them.

Document the legislation assessment

Keep a record showing which EU legislation was considered and why certain legislation was included or excluded.

Ensure production remains compliant

Compliance should not be established only for the product sample that was tested. The company must also have controls to ensure that mass-produced products continue to meet the same requirements.

Introduce a change-control process

Changes can affect CE compliance. Review the Declaration of Conformity when there are changes such as:

• Product or design changes.

• Replacement of components.

• Supplier changes.

• Changes in manufacturing processes.

• Revisions to applicable standards.

7. Common CE Compliance Findings

Some common problems identified during compliance reviews include:

1. Declaration of Conformity is missing, while only a test report is available.

2. Applicable EU legislation has not been fully identified.

3. Standards are listed without evidence showing that the product was actually assessed against them.

4. Risk assessment is missing or inadequate, particularly regarding reasonably foreseeable misuse.

5. Instructions are not translated into the languages required for the countries where the product is sold.

6. Technical documentation does not cover all product variants mentioned in the declaration.

7. No process exists to maintain conformity during series production.

8. Documents are not properly retained or cannot be retrieved when required.

Key Takeaway

CE marking is more than simply putting the CE logo on a product. Manufacturers need to demonstrate compliance through proper documentation, risk assessment, testing, production controls, instructions and ongoing document management.

A well-maintained Declaration of Conformity + Technical File + Change-Control Process provides the foundation for maintaining CE compliance throughout the product lifecycle.