UE DoCCarlo Casati

Milan, 30 September 2016

CE marking

• Legal tool

• Mainly based on new legislative

framework directives

• Fulfilment of essential requirements

• Presumption of conformity if

compliance to harmonised standards

• Application of conformity

assessment procedures

• Asserted by technical

documentation & UE declaration of

conformity.

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CE Marking

What does the CE marking on a product indicate?

By affixing the CE marking to a product, the manufacturer declares on his sole

responsibility that the product is in conformity with the essential requirements of

the applicable Union harmonisation legislation providing for its affixing and that

the relevant conformity assessment procedures have been fulfilled. Products

bearing the CE marking are presumed to be in compliance with the applicable

Union harmonisation legislation and hence benefit from free circulation in the

European Market.

What is a manufacturer’s Declaration of Conformity?

The EU Declaration of Conformity (EU DoC) is a document in which the

manufacturer, or his authorised representative within the European Economic

Area (EEA), indicates that the product meets all the necessary requirements of

the Union harmonisation legislation applicable to the specific product. The EU

DoC must be signed by an individual working for the manufacturer or his

authorised representative, and the employee’s function shall also be indicated.

Whether a Notified Body has been involved or not, the manufacturer must draw

up and sign the EE Declaration of Conformity.

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How should the EU DoC look like ?

Decision

768/2008/EC

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Presumption of Conformity

Conformity

Presumption

of Conformity

Essential Requirements

(must)

Harmonised standards

(possibility)

Ceases if:

The harmonised standard expires

The contrary is proved

• The conformity of a product may be

demonstrated not only by

harmonised standards but also by

other technical specifications.

• Other technical specifications

however do not benefit from the

presumption of conformity.

Why standards are used or not used ?

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Used • Presumption of

conformity through standards requires often less resources (time, money, competence, …) than proving essential requirements.

• Standards are worldwide recognised, may be used commercially. N

otU

sed • By means of technical

documentation the conformity of a product family can be derived (this is not possible for global approach and standard based product certification).

• No specific standards are available

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Maintaining the DoC

• The DoC should be updated:

• If the contact information for the manufacturer changes

• If device model or other information changes

• When harmonised standards change

• If conformity assessment changes

• If Directive Changes