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.
Various types depending on countries.
* 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.
RoHS & WEEE
Visit our CE marking and EU Directives on Medical Devices page for more information.
*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.
* 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.
A full list of product categories may be found here.
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.
* 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.
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.
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.