Which Products Require CE Marking?

Products that often require CE marking include:

Products That Do Not Need CE Marking

Items like chemicals, pharmaceuticals, and cosmetics follow different regulations and do not need CE marking.

Documents Required for CE Certification

Technical Dossier

Manufacturers must compile a technical file detailing how the product meets EU requirements. This includes design, manufacturing, and operation details.

Manufacturer’s Declaration of Conformity

This is a formal statement by the manufacturer confirming that the product complies with all relevant EU directives.

Other required documents often include:

Step-by-Step Guide to Obtaining CE Marking

Step 1- Identify EU Requirements Figure out which directives and regulations apply to your product. Different products fall under different rules.

Step 2- Assess Product Compliance Ensure your product meets the specific standards required by the applicable EU directives.

Step 3- Conduct Product TestingYou may need to test your product, either in-house or via an external lab, to prove compliance.

Step 4- Compile Technical FileGather all documentation into a technical file that can be reviewed if requested.

Step 5- Affix CE Mark and Issue Declaration Finally, place the CE mark on the product and issue a Declaration of Conformity.

Understanding Self-Certification and Notified Bodies

Minimal Risk Products

Some products with low risk can be CE-marked through self-certification —the manufacturer simply declares conformity.

When to Involve a Notified Body

For higher-risk products, an independent third-party (called a Notified Body) must verify compliance. This ensures the product meets strict safety standards before hitting the market.