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General overview of CE marking

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Transcript of General overview of CE marking

What does it means ?
What
CE marking means that a product complies with European safety requirements.

National standards can't be compulsory for products concerned by CE marking.
The 4 main steps of CE marking
For which products?


Active implantable medical devices
Appliances burning gaseous fuels
Cableway installations designed to carry persons
Construction products
Eco-design of energy related products
Electromagnetic compatibility
Equipment and protective systems intended for use potentially explosive atmospheres
Explosives for civil uses
Hot-water boilers
In vitro diagnostic medical devices
Lifts

CE marking in a nutshell
Who does what ?
Where can I find
useful information?
European Commission's website
http://ec.europa.eu/enterprise/index_en.htm

Notifying authorities
http://ec.europa.eu/enterprise/newapproach/nando/index.cfm?fuseaction=na.main

CE marking template
http://ec.europa.eu/enterprise/faq/ce-mark.htm

European Committee for Standardization
http://esearch.cen.eu/esearch/

Your national standardization body
http://www.cen.eu/cen/Members/Pages/default.aspx

The blue guide
http://ec.europa.eu/enterprise/policies/single-market-goods/files/blue-guide/guidepublic_en.pdf

4- How to affix the CE marking ?
Low Voltage Devices
Machinery
Measuring Instruments
Medical devices
Noise emission in the environment
Non-automatic weighing instruments
Personal protective equipment
Pressure equipment
Pyrotechnics
Radio and telecommunications terminal equipment
Recreational craft
Restriction of Hazardous Substances in Electrical and Electronic Equipment
Safety of toys
Simple pressure vessels
1 - Identify the directive(s) and harmonised standards applicable to the product
A product can be concerned by more than one directive

Some products in directive's scope can be exempted

Harmonized European standards give technical terms in order to fulfill directives essential requirements.

They are not compulsory (except for construction products)
the best way to prove product's compliance with CE marking's requirements
Thank you

Any questions ?
Tiphaine ROCTON
tiphaine.rocton@lorraine.cci.fr
2- Which procedure to comply with the essential requirements ?
The procedure depends on the product's dangerousness
check which one is applying
3- Which paperworks ?
The technical documentation
Information required to show that the product properly complies with the requirements of the directives.

Usually :
Description of the product
Conceptual design and manufacturing drawings
List of standards applied
Records of risk assessments and assessments to standards
Test reports
Copy of instructions (user, maintenance, installation)
Quality control & commissioning procedures
CE declaration of Conformity
Each directive lists the compulsory information
Only for relevant national authorities (fraud,customs...)
The EC declaration of conformity
The manufacturer must draw it up and sign it


attest the conformity of the products
information required are listed on each directive
EC declaration of conformity must be linked to the product

It is compulsory to provide it to the client and to relevant national authorities
Must be placed visibly and legibly on the product

Must be indelible

If not possible, affixed to the packaging and the accompanying document

Not smaller than 5 mm

Proportions are compulsory

If a Notified Body is involved, its identification number must be also displayed.

Some texts ask for supplementary markings/information
Manufacturers
Importers
Distributors
Verify requirements

Check for conformity

Draw up the technical documentation and the EC declaration of conformity

Affix the CE marking
Why is it important?
No conformity

Insurance

Customs and fraud
Client's reinsurance

Fees
Only products in conformity with EU rules

Check manufacturer's knowledge and implementation of CE marking requirements

Have a written assurance that the compulsory documents are available upon request

Verify that they are correctly written

Providing the EC declaration of conformity

If importers market the products under their own names, they take over the manufacturer’s responsibilities.
sufficient information on the design and production of the product

assuming the legal responsibility when affixing the CE marking
Ensure that storage and handling do not affect product's compliance

Affirmation from the manufacturer or the importer that the necessary measures have been taken and that technical documentation is available upon request.

Providing the EC declaration of conformity

If distributors market the products under their own names, they take over the manufacturer’s responsibilities.
sufficient information on the design and production of the product

assuming the legal responsibility when affixing the CE marking
Where?
28 Member States and Iceland, Norway, Liechtenstein
Why ?
Where ?
Your EEN colleagues
Guides
Specific forum on Merlin
Full transcript