EUROPE : CERINS (ENG)

What is CE Marking?

CE Marking (Conformité Européenne) is a mandatory conformity marking for products placed on the market within the European Economic Area (EEA). By affixing the CE marking, the manufacturer declares that the product complies with the requirements set out in applicable EU product legislation.

The CE marking allows products to be freely moved and marketed throughout the EU, regardless of where they are manufactured. It is required only for products that fall under harmonised EU legislation which explicitly mandates CE marking.

The manufacturer is responsible for ensuring that the product meets all applicable EU requirements and for affixing the CE marking. When required by legislation, a Notified Body—an independent organization designated by an EU Member State—may be involved in assessing product conformity. Notified Bodies are typically used for third-party conformity assessments of higher-risk products.

When a Notified Body is involved, its four-digit identification number must appear next to the CE marking.

Our Comprehensive CE Marking Support

Gap Analysis & Product Assessment

Determine which EU directives and regulations apply to your product
Identify current compliance gaps and requirements
Assess technical documentation and test report needs
Review product design against applicable standards
Provide a clear roadmap to achieve CE compliance

Technical Documentation Preparation

Compile comprehensive Technical Files as required by EU legislation
Prepare Declaration of Conformity (DoC) documents
Document risk assessments and safety analyses
Create user manuals and safety instructions in required languages
Maintain proper documentation for regulatory inspection readiness

Testing and Certification Coordination

Connect with accredited EU Notified Bodies when required
Coordinate product testing to relevant EN (European Norm) standards
Manage the certification process for products requiring third-party assessment
Review and verify test reports for compliance
Support module selection under the New Legislative Framework

Applicable Product Categories

Our CE marking services cover a wide range of consumer products including:

Toys (Toy Safety Directive 2009/48/EC)
Electrical and electronic equipment (Low Voltage Directive, EMC Directive, RoHS)
Personal Protective Equipment (PPE Regulation EU 2016/425)
Machinery and equipment (Machinery Directive 2006/42/EC)
Construction products (CPR 305/2011)
Medical devices (MDR 2017/745, IVDR 2017/746)
Radio equipment (RED 2014/53/EU)
Pressure equipment (PED 2014/68/EU)

Post-Market Surveillance Support

Guidance on maintaining CE compliance throughout product lifecycle
Support for design modifications and recertification
Assistance with market surveillance authority inquiries
Training on EU compliance obligations and best practices
Updates on regulatory changes affecting your products

CERTIFICATION

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