When CE marking is mandatory
CE marking certification is legally required only for products falling under one or more EU directives or regulations that explicitly demand it. If a product is not covered by such legislation, CE marking must not be used, even voluntarily.
Typical product groups include:
● Electrical and electronic devices (e.g., under the Low Voltage Directive, EMC Directive, and Radio Equipment Directive).
● Machinery, toys, personal protective equipment, pressure equipment, and certain construction products.
● Many consumer goods may impact user safety, health, or the environment when placed on the EU market.
Responsibilities of manufacturers and other actors
The CE mark is primarily the responsibility of the manufacturer or the entity placing the product on the EU market.
Key responsibilities:
● Manufacturers must identify all applicable EU legislation, carry out conformity assessment (self-assessment or via a notified body), and compile a complete technical documentation file.
● They must draw up and sign an EU Declaration of Conformity (DoC) stating that the product meets all relevant requirements and keep this documentation available for at least 10 years after the last unit is placed on the market.
● Importers and distributors must check that products bear the CE mark, are accompanied by required documents, and that the manufacturer has fulfilled its obligations before making products available in the EU.
Core steps to obtain CE marking
While details vary by product category, the CE compliance journey usually follows a structured process.
Typical step sequence:
1. Identify applicable directives and regulations
Determine which EU laws cover the product (e.g., EMC Directive 2014/30/EU, Machinery Directive 2006/42/EC, Radio Equipment Directive 2014/53/EU).
2. Assess essential requirements and harmonised standards
Map relevant essential safety, health, and environmental requirements, and choose harmonised European standards to demonstrate presumption of conformity.
3. Conduct risk analysis and product testing
Perform a documented risk assessment to identify hazards and verify that design measures and testing adequately mitigate them.
Testing may be done in-house or in external labs, depending on the directive and whether a third-party notified body is required.
4. Compile the technical documentation
Prepare a technical file covering product description, design drawings, bill of materials, risk analysis, test reports, user instructions, and compliance evidence.
5. Draw up the EU Declaration of Conformity
The manufacturer signs a DoC listing applied directives, regulations, and standards, formally declaring compliance.
6. Affix the CE mark correctly
The CE marking must be visible, legible, and indelible, affixed to the product, its data plate, or packaging in line with the design and placement rules.
Why CE marking matters for businesses
For manufacturers and exporters, CE marking is both a legal requirement and a strategic advantage.
Key benefits:
● Legal access to all EU and EEA markets with a single set of regulatory approvals, avoiding separate national certifications.
● Increased trust from customers, regulators, and partners because the mark signals systematic control of safety and regulatory risks.
● Streamlined product portfolio management, as harmonised standards enable consistent design and testing strategies across multiple EU countries.
Treating CE marking as a continuous compliance system—rather than a one‑time label—helps companies reduce recall risks, maintain market access, and support sustainable growth in the European market.
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