European Union
Capitalise on the market opportunities in the European Union
The 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.
Market access information by category
Click on the respective blue bars below to get market access information for each category.
Plug type
Various types depending on country
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- The Energy-related Products (ErP) Directive has repealed the Energy-using Products (EuP) Directive, extending the scope of eco-design requirements to all ErPs.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 & 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
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.
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.
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.
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.
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.
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 Product
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.
1Since 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 for Industrial Product
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.
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
TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with EU1 (and individual country) requirements and obtaining the necessary approval.
1EU Directives are the minimum requirements that manufacturers must meet for products to enter the EU. However, individual country requirements may also be applicable.
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.
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
TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with EU1 (and individual country) requirements and obtaining the necessary approval.
1EU Directives are the minimum requirements that manufacturers must meet for products to enter the EU. However, individual country requirements may also be applicable.