EU Certification Services

The CE-Certificate.EU expert group offers the following services to enterprises:

1. Assessment of conformity (certification) of products to the requirements of European Directives and Regulations 
2. Regulatory and technical support of projects 
3. Services of an Authorized Representative in the EU 
4. Creation of a Quality Management System (QMS) at the enterprise
  • 1. Conformity assessment (certification) of products with the requirements of European Directives and Regulations

    1.1 Products by Industry CE marked:

    • Machinery (machines and mechanisms)
    • Electrical and electronic equipment
    • Radio equipment
    • Pressure equipment
    • Equipment and protective systems intended for use in a potentially explosive atmospheres
    • Personal protection equipment
    • Measuring instruments
    • Medical devices
    • Construction products
    • Toys

    1.2  Products requiring certification (but not requiring CE marking):

    • Products intended for contact with food products
    • Textiles used as items for children
    • Garden furniture
    • Sports simulators
    • Equipment used as recreation on water
    • Some other products

    1.3  EU Product Certification Procedures:

    • Development of procedure for product conformity assessment according to European Directives, Regulations and international standards
    • Testing of products in EU-accredited laboratories for compliance of product parameters and characteristics with European and international standards
    • Risks analysis at all stages of the production and application life cycle, preparation of proposals for risk reduction
    • Analysis of the company's quality management system (QMS) in accordance with European regulatory requirements
    • Preparation of Technical File documents in accordance with EU Directives and Regulations
    • Compliance Confirmation of Technical Files documents for Products and QMS with EU-certified bodies in accordance with the requirements of European Standards, Directives and Regulations
    • Submission to enterprises of the official Certification Conclusion (certificate) of the EU Notified Body
    • Conformity Declarations and CE labelling projects preparation

    1.4  Testing of product samples for compliance with the requirements of European and international standards:

    • Selection of European test laboratories accredited by EN standards
    • Receipt of product samples from the manufacturer, customs clearance in the EU zone and delivery to the EU-accredited test laboratory
    • Tests Monitoring in the EU-accredited laboratory and customer information
    • Prompt problems solution with the testing laboratory
    • Provision of Test Reports and Classification Conclusions to the manufacturer

    1.5  Services:

    • Product Life Cycle Assessment (LCA) and Product Environmental Declaration (EPD) as required by EN 15804
    • Vehicle type testing and confirmation services for agricultural wheeled and tracked tractors and their trailers in accordance with the requirements of Regulation (EU) 167/2013

    1.6 RoHS:

    • Assessment of the restriction of the use of certain hazardous substances in electrical and electronic equipment
  • 2. Regulatory and technical support of projects

    Within the framework of regulatory technical support of projects, our expert group ensures:

    • Provision of information on existing official documents of the European Union
    • Purchase and supply to manufacturer of existing EN standards in English with licensed overprint
    • Provision of information on EU regulations, documents, and reference materials newly introduced
    • Translation of EN standards as well as EU Directives and Regulations into Russian
    • Information on implementation of new harmonized European standards in the EU, information on changes and additions in the existing harmonized European standards

     

  • 3. Authorized Representative services of the Enterprise in EU

    The need for an Authorized Representative in EU countries for a product supplier is determined by the requirements of the European Directives and Regulations.

    The authorized representative acts by proxy of the manufacturer. The terms and functions of the Authorized Representative shall be determined within the framework of the contract with the manufacturer and on the basis of the Power of Attorney signed by the manufacturer.

    At the request of the national regulatory authorities of the EU countries, the Authorized Representative, in agreement with the manufacturer, may submit to the regulatory authorities documents of the Technical File, including product test reports.


  • 4. Creation of a quality management system (QMS) at the enterprise

    The presence of a functioning Quality Management System in the enterprises according to the requirements of the international standard ISO 9001 (QMS) or Factory Production Control (FPC) is a mandatory condition of the EU Directives and Regulations when supplying products to the European Union market.

    To create a QMS (or FPC) at the enterprise, our expert group provides:

    • Preliminary analysis of the Company's Quality Management System (QMS) or Factory Production Control (FPC)
    • Identification of inconsistencies in QMS operating at the enterprise and preparation of proposals for their elimination
    • Development of QMS documents draft
    • Participation in preliminary audit of QMS (FPC) as well as joint audit with EU-notified body 
    • Preparation of proposals for revision of QMS (FPC) based on audit results
    • Execution of the EU Certificate for the Quality Management System (QMS) or Factory Production Control (FPC)

  • 5. Issued certification documents (list)

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