European Union

Capitalise on the market opportunities in the European Union

EU-UnionThe European Union consists of 28 member states located in Europe. For most products entering the EU, there are harmonised regulations (EU Directives) which need to be complied with depending on its product scope. Most directives will require a CE Mark, a mandatory mark that demonstrates a manufacturers’ compliance to applicable EU directives. Individual country requirements may also apply.

CLICK ON THE RESPECTIVE CATEGORIES BELOW TO GET MARKET ACCESS INFORMATION TO EACH CATEGORY

  • Plug Types

    Various types depending on countries.

  • Electrical Safety

    Regulatory agency

    • European Commission (EC)

    Regulations

    • CE marking*, according to EU Directives, is mandatory.
    • DoC is sufficient but certification is recommended for marketing.
    • Product safety testing is required.
    • Compliance with European EN standards.
    • * CE marking is not a certification, approval or quality mark, but a manufacturer’s declaration that the product meets the essential requirements of the respective directives. Most EU Directives require CE marking.

  • EMC

    Regulatory agency

    • European Commission (EC)

    Regulations

    • CE marking according to EMC Directive.
  • Environmental

    Regulatory agency

    • European Commission (EC)

    Regulations

    ENERGY EFFICIENCY

    • The Energy-related Products (ErP) Directive has repealed the Energy-using Products (EuP) Directive, extending the scope of eco-design requirements to all ErPs.
    • The EC is still reviewing its effectiveness. For product categories with regulations in force, CE marking applies.

    RoHS & WEEE

    • RoHS is a CE marking directive. Even though WEEE is not a CE marking directive, products must comply with the RoHS and WEEE Directives where applicable.
    • Manufacturers must register compliance in target countries.
  • Medical Devices

    Regulatory agency

    • European Commission (EC)

    Regulations

    • CE marking according to the Medical Device Directive (93/42EEC), Directive of Active Implantable Medical Devices (90/385/EEC) or Directive of In Vitro Diagnostic Medical Devices (98/79/EC) is required.

    Visit our CE marking and EU Directives on Medical Devices page for more information.

  • Telecom & Wireless

    Regulatory agency

    • European Commission (EC)

    Regulations

    • CE marking according to telecom and wireless directives.
    • DoC is sufficient but certification is recommended for marketing. Where there is lack of harmonised standards, it is necessary for manufacturers to engage a Notified Body*.
    • *Notified bodies are organisations that have been accredited by EU Member States to serve as independent test laboratories to access whether products meet the requirements of product directives. They must have the necessary qualifications to meet the testing requirements set forth in the directives.

  • More information on EU regulations

    GUIDELINES

    CE MARKING PROCEDURE

    • Identify the directives that apply to the product. If more than one applies, all must be complied with.
    • Determine the extent to which the product complies with the requirements of the applicable directive(s).
    • Choose the conformity assessment procedure* based on the directive for your product.
    • Select the applicable product standards and test methods for your product and select an independent laboratory if the directive(s) states that product testing is to be done externally.
    • Compile the Technical File of technical documentation for your product. The Technical File holds information that verifies that the testing was conducted properly and that the product complies with applicable standards; it is product dependent.
    • Prepare a DoC declaring that the product fulfils the requirements of the applicable directive(s) with the legally binding signature of the manufacturer.
    • Affix the CE mark to your product. There are specific rules to adhere to in CE marking.
    • * Conformity Assessment Procedure options for products with minimal risk include DoC while products with greater risks may require tests, audits or additional certificates from a Notified Body.

    APPLICABLE PRODUCT CATEGORIES

    Product categories requiring CE marking include the products listed below.

    • Cableway equipment
    • Electrical products
    • Gas appliances
    • Medical devices
    • Telecommunications equipment
    • Toys

    A full list of product categories may be found here.

    Product groups with regulations according to the ErP Directive include:

    • Consumer electronics (televisions)
    • Electric motors
    • External power supplies
    • Household refrigerating appliances
    • Non-directional household lamps
    • Simple set-top boxes
    • Standby and off-mode losses
    • Tertiary sector lighting

    To determine if a particular product is subject to the above regulations, please contact us.

    WHY CHOOSE TÜV SÜD?

    TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with EU*(and individual country) requirements and obtaining the necessary approvals. The TÜV SÜD family is a Notified Body with the expertise and capability to test your product to a large variety of Directives.

    TÜV SÜD can provide:

    • Expert opinions in the compliance of CE marking requirements
    • Test reports to support Technical File documentation
    • CE marking
    • Certification of Conformity** for safety, EMC, energy efficiency, RoHS & WEEE and applicable standards

    * EU Directives are the minimum requirements that manufacturers must meet for products to enter the EU. However, individual country requirements may also be applicable.

    ** In addition to CE marking, which is simply a symbol for trade with the assumption of conformity, TÜV SÜD Marks are a certification of compliance with European (EN) standards.

  • Industrial Products

    Regulatory agency

    • European Commission (EC)

    Regulations

    • A declaration of conformity, issued by the manufacturer or its authorised representative, allows the product to be marked with the CE mark and offered for sale in the EU1.
    • The “ATEX” Directive 94/9/EC which provides the technical requirements to be applied to equipment intended for use in potentially explosive atmospheres.

    1 Since many machines contain electrical components or functions, the Low Voltage Directive and the EMC Directive may also be applicable and both of these directives contain additional requirements, which must be satisfied before CE marking can be applied.

  • More information on EU regulations on Industrial Products

    Guidelines

    MACHINERY (SAFETY) REGULATIONS:

    • The machinery must be able to satisfy the Essential Health and Safety Requirements (EHSRs) for any corresponding hazard which may apply to it.
    • Technical Construction File: containing technical information relative to the machinery.
    • Declaration.
    • CE mark: affix the CE mark to machines which are issued with a Declaration of Conformity only.
    ATEX DIRECTIVE:

    • For products with an EC type examination, a quality audit of your facility will be required by one of our team of technical certifiers, locally located throughout the world, providing a cost effective solution. As a Notified body we are able to offer product certification for a wide range of both electrical & non-electrical equipment under the 94/9/EC directive.

    Applicable Product categories

    • All machines supplied in the European Economic Area (EEA) from January 1st 1995, must comply with the Machinery Directive 2006/42/EC and be safe.

    The following products will be affected by the ATEX Directive:

    • Equipment: Machines, operating equipment, devices, control components and instrumentation
    • Protective systems: Explosion suppression systems, relief systems and other systems
    • Components: Components essential to the safe functioning of equipment and protective systems

    WHY CHOOSE TÜV SÜD?

    • TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with EU1 (and individual country) requirements and obtaining the necessary approval.

    1 EU Directives are the minimum requirements that manufacturers must meet for products to enter the EU. However, individual country requirements may also be applicable.

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