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Product Service
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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:
applicable directives.
• 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 Ltd
TÜV SÜD Group
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Product Service
www.tuvps.co.uk
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 Ltd • 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: [email protected]