EuropeAid /114385/D/SV/CY ProjectAssessment and administration capacity buildingfor the harmonisation with the New Approach directives

SEMINAR on New Approach DirectivesMarch 4+5, 2004 in Nicosia

Directive 2000/9/EC of the European Parliament and of the Council

of 20 March 2000 relating to

CABLEWAY INSTALLATIONS DESIGNED TO CARRY PERSONS

Administrative Obligations

The views expressed in this publication do not necessarily reflect the views of the European Commission.

CablInst – Administrative Obligations:

The Technical Document

• The producer may assume that the documentation will be

examined by an expert.

• Know-how in the product area may be expected from the

market surveillance authorities

• No need to start with all the basics.

• The documentation should not be excessively voluminous.

• The documentation can be maintained in electronic format.

• Part A & B, Part A should be at hand at all times

• at least 10 years after the last date of manufacture of the

product concerned.

CabLinst – Administrative Obligations:The Technical Document - part A

• First aid kit

• Name(s) and adress of mft.

• ID of product

• Description (prospectus)

• Manual

• Declaration of conformity

• List of standards & directives

• Content of part B

CablInst – Administrative Obligations:The Technical Document - part B

• Start with the Essential Requirement at top of page

• Identify the hazards

• Proof of remedy:

– a general type-description,

– conceptual design and manufacturing drawings and diagrams of

components, subassemblies, circuits, etc.,

– descriptions and explanations necessary for the understanding of

the drawings and diagrams and the operation of the product,

– a list of the standards applied in full or in part, and descriptions of

the solutions adopted to meet the essential requirements of the

Directive where the standards have not been applied,

– results of design calculations made, examinations carried out, etc.,

– test reports.

CablInst – Administrative Obligations:

The Manual

• From start to finish

• Essential for limiting product liability

• Suitable instructions in respect of

– safe handling,

– storage,

– use

– disposal

• in the official language or languages of the

recipient Member State.

CablInst – Administrative Obligations:

The Declaration of Conformity

• Need a model: PPE• The EC declaration of

conformity should contain all relevant information to identify the directives according to which it is issued, as well as the manufacturer, the authorised representative, the notified body if applicable, the product, and where appropriate a reference to harmonised standards or other normative documents.

CablInst – Administrative Obligations:The Declaration of Conformityfor Subsystems

• The EC declaration of conformity must be drawn up by the manufacturer, or his authorised representative established in the Community, or the person who places the subsystem on the market

• The declaration of conformity and the technical documentation must be drawn up in the same language or languages as the instruction manual

• The declaration must state the following particulars

1. the reference of this Directive,

2. the name and address of the person who ordered EC examination,

3. a description of the subsystem,

4. the name and address of the notified body which carried out the EC examination,

CablInst – Administrative Obligations:The Declaration of Conformityfor Subsystems

The declaration must state the following particulars

5. all relevant provisions with which the subsystem must

comply, in particular any operating restrictions or

operating conditions,

6. the outcome of EC examination referred to in Annex VII

(EC conformity certificate),

7. particulars of the person who is authorised to sign a legally

binding declaration for the manufacturer, or his authorised

representative or, where such a person is not available, the

natural or legal person, who places the subsystem on the

market.

CablInst – Administrative Obligations:The Declaration of Conformityfor Safety Components

• The declaration must be drawn up in the same language or languages as the instruction manual

• The declaration must state the following particulars1. the references of this Directive,

2. name, business name and full address of the manufacturer or his authorised representative established in the Community. An authorised representative must also give the name, business name and full address of the manufacturer,

3. description of the component (make, type, etc.),

4. details of the conformity declaration procedure used

5. all relevant provisions with which the component must comply and, in particular, the conditions of use,

CablInst – Administrative Obligations:The Declaration of Conformityfor Safety Components

• The declaration must state the following particulars6. the name and address of any body notified,

involved in the conformity procedure and the date of the EC examination certificate with details, where appropriate, of the duration and conditions of validity of the certificate,

7. where appropriate, the reference of the harmonised standards applicable

8. identification of the person empowered to sign on behalf of the manufacturer or his authorised representative established in the Community.

9. It must be dated and signed.

CablInst - CE-marking & Labelling:

Requirements

The CE marking of conformity shall be affixed in such a way as to be

• visible, • easily legible and • indelible • on the product itselve or,

• if this is not possible, on an identification plate attached thereto or, • in the last resort, if the first two methods cannot be used, on the packaging.

• The identification plate must be so designed as to make its reuse impossible.

• The model to be used for the CE marking shall be that reproduced in Annex IX.

CablInst - CE-marking & Labelling:

Confusion with other markings

• It is illegal to affix on Safety Components any mark or

inscription which may confuse third persons as to the

meaning and style of writing of the CE marking.

• Any other mark may be affixed on Safety Components

provided the visiblility and legibility of the CE marking

is not impaired