Navigating CE Marking for EU Market Entry

CE marking is not optional. If your product falls under EU directives (machinery, electronics, medical devices, toys, etc.), you must affix the CE mark before you can legally sell in the European market.

What Is CE Marking?

CE marking is a certification that your product meets EU safety, health, and environmental protection standards. It is not a quality mark, but a legal requirement for market access.

Key points: - Mandatory for products covered by EU directives - Self-declaration (for some products) or third-party certification (for high-risk products) - Failure to comply results in customs holds, fines, or market exclusion

Which Products Require CE Marking?

Common categories include: - Machinery (Machinery Directive 2006/42/EC) - Electrical and electronic equipment (Low Voltage Directive, EMC Directive) - Medical devices (Medical Devices Regulation 2017/745) - Personal protective equipment (PPE Regulation 2016/425) - Toys (Toy Safety Directive 2009/48/EC) - Construction products (Construction Products Regulation 305/2011)

If your product does not fall under any directive, CE marking is not required (but other regulations may apply).

The CE Marking Process

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Step 1: Identify Applicable Directives Determine which EU directives apply to your product. Some products fall under multiple directives (e.g., an industrial robot may need Machinery, Low Voltage, and EMC compliance).

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Step 2: Verify Conformity Ensure your product meets the essential requirements of each directive. This may require: - Design changes - Material substitutions - Safety testing - Documentation (technical files, risk assessments)

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Step 3: Testing and Certification - Self-declaration: For low-risk products, you can self-certify by creating a Declaration of Conformity and technical file. - Notified Body: For high-risk products, you must engage an EU Notified Body (accredited certification lab) to test and certify your product.

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Step 4: Create Technical Documentation You must maintain a technical file that includes: - Product description and specifications - Risk assessment - Test reports - Declaration of Conformity - User manuals

This file must be available for inspection by authorities for 10 years after the product is placed on the market.

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Step 5: Affix CE Mark and Declare Conformity Once conformity is verified, you affix the CE mark to your product (or packaging if impractical) and issue a Declaration of Conformity.

Timeline and Costs

- Self-declaration: 2-6 weeks, EUR 2,000-10,000 (mostly internal labor and documentation) - Notified Body certification: 3-6 months, EUR 10,000-50,000+ (depending on product complexity and testing requirements)

Common Pitfalls

1. Assuming CE marking is not required: Check early. Customs will not accept ignorance as an excuse. 2. Using non-EU Notified Bodies: Only EU-accredited Notified Bodies are recognized. US or Asian certifications do not substitute. 3. Incomplete technical files: Authorities can request documentation at any time. Missing files result in fines or market withdrawal. 4. Counterfeit CE marks: Affixing a CE mark without proper conformity assessment is illegal and results in severe penalties.

Brexit Note

Post-Brexit, products sold in the UK require UKCA marking instead of (or in addition to) CE marking. Plan for dual certification if serving both EU and UK markets.

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Need help navigating CE marking or other EU compliance requirements? Meritum provides end-to-end Customs & Compliance services to ensure your products meet all regulatory requirements before market entry.