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CE Marking CE Marking is a mandatory legal conformity requirement for all products sold within the European Union that fall within the scope of a CE marking directive. By affixing a CE Marking logo to a product and signing the Declaration of Conformity, a product supplier is declaring to the EU authorities that the requirements of all applicable directives have been met. Depending on the directive, involvement of a European Union ‘Notified Body’ may be mandatory or voluntary. TÜV SÜD Product Service assists companies to demonstrate their products’ compliance with the requirements of all applicable CE marking directives, by offering testing and certification in line with these requirements.
CE Marking Services • Advice • Assessments • Testing • Training CE Marking Process • Decide which directives are applicable to your product. • Ensure that your product is compliant with the
To those unfamiliar with the CE marking process, the EC directives can seem confusing and the simple steps described above quite complex when addressing the requirements in detail. Advice and technical testing services from an external expert can usually speed up the CE marking process and get the product to market much faster than would otherwise be the case.
TÜV SÜD Product Service or BABT are accredited as a Notified Body against the following CE Marking Directives: • Low Voltage Directive 2006/95/EC • EMC Directive 2004/108/EC • R&TTE Directive 1999/5/EC • Machinery Directive 98/37/EC • In-vitro Diagnostic Medical Devices Directive 98/79/EEC
• Active Implantable Medical Devices Directive 90/385/EEC • Medical Devices Directive 93/42/EEC
Benefits of using TÜV SÜD Product Service for CE Marking:
• Compile and retain a technical file, which
• You can sign your declaration of conformity
satisfies the requirements of the directives. • Write and sign a Declaration of Conformity, which has a format that satisfies the requirements of the applicable directives, and keep the original with the technical file. • Apply CE marking to the equipment in accordance with the requirements of the directive.
with confidence that your products are compliant. • You receive comprehensive support in following the CE marking procedures. • You benefit from TÜV SÜD Product Service’s wide-ranging knowledge of EU directives.
TÜV SÜD Product Service TÜV SÜD Group
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CE Marking Frequently Asked Questions ‘CE’ stands for Communauté Européenne (European Community). Introduced in 1995, CE Marking was created to stimulate the free circulation of goods within the European Community. What does CE Marking signify? CE marking when applied to any product or equipment indicates that the manufacturer or its authorised EU representative has declared that the product or equipment complies with all applicable European Directives. Who can perform CE Marking? The company that places the product or equipment on the market is responsible for declaring that the item is compliant with all applicable EU Directives and for placing the CE marking on the product or equipment. The responsibility for CE marking will fall on the manufacturer if the manufacturer is EU-based and selling products directly or on the manufacturer’s agent within the European Union if the manufacturer is based outside of the European Union. Third parties cannot apply the CE marking or make declarations of conformity unless they are responsible for placing the product in the EU. Who is responsible for affixing the CE Marking? The manufacturer of a product is responsible for ensuring compliance with European Directives and for affixing the CE marking – irrespective of whether the manufacturer is located within or outside the European Union. To do this, manufacturers may appoint an authorised representative established in the European Union to act on their behalf.
The CE marking is generally a declaration by the manufacturer, importer, or the entity first placing the product on the market that the product conforms to the appropriate directives. This is confirmed by the legally binding signature on the Declaration of Conformity. I am a manufacturer, importer, or entity placing the product on the market. When do I have to affix the CE Marking? For you as a manufacturer, importer, or entity first placing the product on the EU market, CE marking is mandatory if your product is covered by a CE Marking Directive. By fixing the CE marking to your product, you are responsible for ensuring that your product complies with the requirements of all relevant EU Directives and for providing documentary evidence of conformity. If you fail to deliver the requisite evidence of conformity in your capacity as a manufacturer or importer, the competent market surveillance authority may prohibit you from placing your products on the market. Gaining a competitive edge with the CE Marking through a Notified Body certification or opinion. The CE marking itself is solely a means to facilitate the free passage of goods throughout Europe and to demonstrate compliance with uniform safety standards. Although CE marking is mandatory, you can still use it to carve out a competitive profile for your company and your machinery by asking a recognized EU Notified Body such as TÜV SÜD Product Service or BABT to assess your products and by showing the Notified Body's registration number alongside the CE marking on your product. CE marking thus becomes an opportunity for you to demonstrate to your customers that your product has been independently assessed against all applicable standards.
TÜV SÜD Product Service • TÜV SÜD Group Octagon House • Concorde Way • Segensworth North • Fareham Hampshire • PO15 5RL • United Kingdom Tel: +44 (0)1489 558202 • Fax: +44 (0)1489 558101 • Email: firstname.lastname@example.org