CE Marking Requirements Guide: Complete Certification Process 2025
If you manufacture or distribute products in the European Union, you need to understand CE marking. This guide explains the CE marking requirements, including CE certification requirements, documentation standards, and how to avoid common mistakes. Use it to ensure your products meet EU regulations and are ready for market entry.
What is CE Marking and When is it Required?
CE Mark Purpose and Legal Framework
The CE mark (Conformité Européenne) shows that your product complies with EU safety, health, and environmental protection standards. It is not a quality mark, but a legal requirement for many product categories.
Relevant EU legislation includes:
- Machinery Directive (2006/42/EC)
- Low Voltage Directive (2014/35/EU)
- EMC Directive (2014/30/EU)
- Medical Device Regulation (MDR 2017/745)
Products That Require CE Marking
CE marking applies to many product categories sold within the EU. Each category is governed by its own directive or regulation, which sets out the essential requirements for safety, performance, and documentation. Understanding where your product fits helps you determine which obligations apply and what evidence you need to prepare.
- Electrical and electronic equipment
- Machinery and tools
- Medical devices
- Toys
- Construction products
- Personal protective equipment (PPE)
Check the specific directive that applies to your product.
EU Market Access Requirements
Without the CE mark, your product cannot be legally sold in the EU or European Economic Area (EEA). Customs authorities may block your shipment, and market surveillance bodies can recall non-compliant products.
CE Marking vs Other Compliance Marks
The CE mark is not the same as UKCA, FCC, or UL marks. Each applies to different regions and follows different rules.
CE Certification Requirements: Essential Checklist
Meeting CE certification requirements means more than placing a logo. You need to complete formal assessments and document compliance.
Conformity Assessment Procedures
Choose the right procedure based on your product's risk level:
Product Manual Requirements
A well-prepared product manual supports safe use, clear communication, and smooth market access. It brings together essential information that helps users understand the product and provides evidence that the correct documentation has been created. Keeping this content organised also makes it easier to respond to requests from partners or authorities.
- Product description and intended use
- Risk assessment
- Design and manufacturing drawings
- Test reports and certificates
- Standards applied
- CE marking artwork
Keep this file updated and ready for inspection.
EU Declaration of Conformity
The EU Declaration of Conformity is the formal document that states a product has been assessed against the relevant EU legislation. It must be complete, accurate, and kept up to date. This document is part of the technical file and may be requested by authorities, distributors, or partners at any time.
- Manufacturer’s name and address
- Product model and description
- Applied directives and standards
- Name and signature of authorised person
- Issue date and place
Authorised Representative Requirements
If you are based outside the EU, you must appoint an EU Authorised Representative. They:
- Act as your legal contact in the EU
- Hold your technical file
- Communicate with market authorities
CE User Manual Requirements
User manuals are a legal part of CE compliance. They must be complete, clear, and accessible in the language of the destination country.
Mandatory Manual Content
Include the following:
Safety Instructions and Warnings
Use plain language and clear formatting to highlight:
- Personal protective equipment (PPE)
- Electrical or mechanical risks
- Emergency procedures
Use standard icons and symbols where possible.
Multi-language Requirements
When placing products on the EU market, user manuals must be available in the official language or languages of the country where the product is sold. This ensures users can understand safety information, installation steps, and operating instructions without relying on translations from third parties. Clear, accessible language versions help support safe and correct product use across all markets.
- Germany: German
- France: French
- Spain: Spanish
Summaries or partial translations are not compliant.
Check out Pergamon's Manual Translation Features!
CE Manual Format and Documentation Standards
Manual Structure and Layout
A clear, logical structure helps users find the information they need quickly, whether they are setting up the product for the first time or troubleshooting an issue. Consistent layout and predictable headings also make the manual easier to navigate, especially for readers who skim rather than read from start to finish.
- Cover page with product name and CE mark
- Table of contents
- Introduction and intended use
- Safety information
- Installation instructions
- Operating instructions
- Maintenance guidance
- Troubleshooting
- Technical specifications
- Legal notices and contact info
Pergamon is built for companies selling products under their own brand into the EU market - including OBMs, virtual OBMs, private-label brands, and manufacturers using their own brand.
Digital vs Print Manual Requirements
Product manuals can be delivered in different formats depending on the market, product category, and distribution method. Digital manuals offer convenience and lower printing costs, while printed manuals remain essential in certain regions or for specific user groups. Understanding these differences helps you choose the right format for each product launch.
- Digital manuals (PDFs, help systems) are acceptable in most cases
- Some markets or products still require printed manuals
- Always confirm with local market authorities
Common CE Marking Mistakes to Avoid
Incorrect CE Mark Application
The CE mark must be applied correctly for it to be recognised by authorities, distributors, and market surveillance teams. Incorrect use can cause delays, rejections, or requests for additional documentation. Following the official guidelines ensures the mark is clear, consistent, and used only where appropriate.
- Use only the official CE logo
- Maintain correct proportions and minimum size (5 mm)
- Do not use the mark on ineligible products
Incomplete Technical Documentation
Technical documentation must be complete, organised, and easy to understand. Missing elements can slow down product launches, create confusion for partners, and make it harder to demonstrate how the product was assessed. Identifying common gaps helps teams strengthen their documentation early in the process.
- Risk assessments
- Product schematics
- Language versions of the manual
Missing Declaration of Conformity
You must include the Declaration of Conformity with the product or manual. Without it, the CE mark is invalid.
Non-Compliant User Manual Format
Manual issues that lead to non-compliance:
Frequently Asked Questions About CE Marking Requirements
Is CE marking mandatory for all products?
No. Only for products covered by EU directives or regulations.
Can I self-declare CE marking?
Yes, for low-risk products. Higher-risk products require a Notified Body.
What languages must manuals be in?
Manuals must be in the official language(s) of the destination country.
How long is CE marking valid?
As long as the product and standards remain unchanged.
What size should the CE mark be?
At least 5 mm high, visible, and permanently applied.
Do I need a Notified Body?
Only for high-risk products or when required by the relevant directive.
Getting Started with CE Marking: Your Action Plan
- Identify relevant EU directives and regulations
- Select the appropriate conformity procedure
- Conduct testing and create technical documentation
- Draft and sign the EU Declaration of Conformity
- Apply the CE mark to your product
- Translate and publish the user manual
- Keep all documentation available for inspection
Need to automate CE manual creation and translations?
Use Pergamon to streamline compliance documentation and multilingual publishing.
