What is CE marking? A plain guide for exporters

Which products need CE marking

CE marking applies only to products covered by EU harmonization legislation, and only those products may carry the mark. Common groups include:

• Electrical and electronic equipment (low voltage, EMC, RoHS, radio equipment)
• Machinery and lifting equipment
• Toys
• Personal protective equipment
• Construction products
• Pressure equipment, simple pressure vessels and gas appliances
• Medical devices and in vitro diagnostics
• Equipment for explosive atmospheres, measuring instruments and weighing instruments

Products outside these groups, such as most furniture or clothing, do not carry the CE mark, although they must still be safe under general product safety rules. Putting a CE mark on a product that is not covered is itself a breach of the rules.

Self-declaration or notified body

Each piece of legislation sets out conformity assessment procedures, called modules. For many lower-risk products, the manufacturer can carry out the assessment alone: test the product, prepare the technical file and declare conformity. This is often the case for low voltage electrical equipment, EMC and many machines.

Higher-risk products need a notified body, an organization designated by an EU member state to assess conformity for specific legislation. Examples include higher-category pressure equipment, certain machinery, higher-category PPE, lifts, gas appliances and most medical devices. The notified body's four-digit number then appears next to the CE mark where the rules require it.

A common misunderstanding is that a CE certificate from any company makes a product compliant. Only the manufacturer's declaration, supported by the right evidence and, where required, a notified body, does that.

The steps to CE marking

• Identify the EU legislation that applies to the product
• Identify the essential requirements and the harmonised standards that give presumption of conformity
• Decide whether a notified body is needed for your product and risk class
• Test the product and carry out a risk assessment
• Prepare the technical file: description, drawings, test reports, risk assessment, manuals and labels
• Sign the EU Declaration of Conformity
• Affix the CE mark and keep the technical file for the required period, often ten years

What US and other non-EU exporters should know

The technical requirements are the same wherever the manufacturer is based. What changes is the paperwork around market access. Products placed on the EU market generally need an economic operator in the EU, such as an importer or an authorised representative, and their details may need to appear on the product or documents.

Products designed for the US market often need changes for Europe: different standards for electrical safety and EMC, European mains plugs and voltages, instructions in the languages of the countries of sale, and EU-specific labelling such as WEEE marking for electrical equipment.

Great Britain uses its own UKCA mark for some products, while continuing to recognise CE marking in many cases. Check the current rules if you sell there.

How long it takes and what it costs

For a simple product with existing test reports, CE marking can be completed in a few weeks. Products that need new testing or a notified body take longer, often months, depending on laboratory and notified body availability.

Cost depends on the number of directives, the testing needed and whether a notified body is involved. EUROTECH offers CE marking packages from $800, with notified body fees included in the package where your product needs one.