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CE Approval Guide for Manufacturers <11>

Regulatory Guide > European Area > European Union > CE Approval Guide for Manufacturers <11>
Manufacturers

Manufacturers play a crucial role in ensuring that products placed on the extended single market of the European Economic Area (EEA) are safe. They are responsible for checking that their products meet EU safety, health, and environmental protection requirements. It is the manufacturer’s responsibility to carry out the conformity assessment, set up the technical file, issue the EU declaration of conformity, and affix the CE marking to a product. Only then can this product be traded on the EEA market.

If you are a manufacturer, you have to follow these 6 steps to affix a CE marking to your product:

  1. Identify the applicable directive(s) and harmonised standards
  2. Verify product specific requirements
  3. Identify whether an independent conformity assessment (by a notified body) is necessary
  4. Test the product and check its conformity
  5. Draw up and keep available the required technical documentation
  6. Affix the CE marking and draw up the EU Declaration of Conformity (27 KB).

These 6 steps may differ by product as the conformity assessment procedure varies. Manufacturers must not affix CE marking to products that don’t fall under the scope of one of the directives providing for its affixing.

For products that present higher safety risks such as gas boilers, safety cannot be checked by the manufacturer alone. In these cases, an independent organisation, specifically a notified body appointed by national authorities, has to perform the safety check. The manufacturer may affix the CE marking to the product only once this has been done.

Product groups

Directives

If your product(s) fall(s) within the sector related to lifts, the following Directive applies.

     

    Verify requirements

    The New Approach Directives for the CE marking have been designed by the European Union in such a manner that they cover all requirements for products from each of the aforementioned sectors.

    The Directive 2014/33/EU on lifts specifies in detail the essential requirements the product must meet in order for the lift installer or the manufacturer of the safety components for lifts to affix the CE marking.

    The directive covers lifts permanently serving buildings and construction and intended for the transport of persons and/or goods. It also applies to the safety components for use in such lifts listed in Annex III.

    It does not cover lifting appliances whose speed is not greater than 0,15 m/s; construction site hoists; cableways, including funicular railways; lifts specially designed and constructed for military or police purposes; lifting appliances from which work can be carried out; mine winding gear; lifting appliances intended for lifting performers during artistic performances; lifting appliances fitted in means of transport; lifting appliances connected to machinery and intended exclusively for access to workstations including maintenance and inspection points on the machinery; rack and pinion trains; escalators and mechanical walkways.

    Lifts covered by this directive must satisfy the essential health and safety requirements set out in Annex I.

    Please consult Directive 2014/33/EU carefully in order to ensure that your product complies with all the essential requirements.

     

    Need for notified body?

    The lift installer or the manufacturer of the safety components for lifts must always involve a notified body in the conformity assessment procedure.

    Also in the case of conformity assessment for lifts, the involvement of a notified body is obligatory.

    A notified body verifies the compliance of a product by conducting a conformity assessment. It also ensures that the technical documentation sufficiently supports product compliance. If the notified body is involved in (a) the final inspection referred to in Annex V; (b) unit verification, referred to in Annex VIII; or (c) quality assurance referred to in Annexes X, XI or XII, its identification number will follow the CE marking.

    Where the type of the safety component for lifts or lift meets the relevant conditions of the Directive, the notified body issues a certificate of conformity to confirm this. Then the lift installer or the manufacturer of the safety components for lifts draws up the EU declaration of conformity (DoC) to declare that it is his sole responsibility to ensure conformity to the relevant directive. The establishment of the EU DoC is a legal obligation.

    The EU declaration of conformity must include the details of the lift installer or of the manufacturer of the safety components for lifts, such as name and address, description of the safety component or of the lift, details of the type or series and serial number (and address where the lift is installed), year of manufacture of the safety component for lift and/or year of installation of lift, all relevant provisions with which the safety component for lifts and/or lift complies, a statement that the safety component or lift is in conformity with the relevant EU harmonisation legislation, where appropriate references to harmonised standards used, any harmonised standards used and the name, address and identification number of the notified body, as well as the name and function of the person empowered to sign the declaration on behalf of the manufacturer or installer, place and date of signature and signature. For further details please consult your specific directive.

    To find the notified bodies appointed by the Member States to carry out conformity assessment, please consult NANDO – the New Approach Notified and Designated Organisations database. You can search for notified bodies by directive or by country via the NANDO homepage.

    Check conformity

    The conformity assessment procedures the lift installer or the manufacturer of the safety components for lifts must follow prior to affixing the CE marking are set out in Chapter III, Articles 15 and 16 of the directive.

    The conformity assessment procedure of the safety components for lifts entails different possibilities

    • EU type examination set out in Annex IV, Part A and the conformity to type shall be ensured with random checking of the safety component for lifts set out in Annex IX
    • EU type examination set out in Annex IV, Part A and be subject to conformity to type based on product quality assurance in accordance with Annex VI
    • conformity based on full quality assurance set out in Annex VII

    The conformity assessment procedure for lifts shall be one of the following

    a) if they are designed and manufactured in accordance with a model lift that has undergone an EU-type examination set out in in Annex IV, Part B

    (i) final inspection for lifts set out in Annex V

    (ii) conformity to type based on product quality assurance for lifts set out in Annex X

    (iii) conformity to type based on production quality assurance for lifts set out in Annex XII

    (b) if they are designed and manufactured under a quality system approved in accordance with Annex XI

    (i) final inspection for lifts set out in Annex V

    (ii) conformity to type based on product quality assurance for lifts set out in Annex X

    (iii) conformity to type based on production quality assurance for lifts set out in Annex XII

    (c) conformity based on unit verification for lifts set out in Annex VIII

    (d) conformity based on full quality assurance plus design examination for lifts set out in Annex XI

    The manufacturer must draw up and sign the EU declaration of conformity.

    Technical documentation

    Upon successful conformity assessment, Directive 2014/33/EU on lifts requires technical documentation (e.g. as laid out in Annex IV) according to the respective conformity assessment procedure. The technical documents must enable assessment of the conformity of the safety component for lifts or of lift with the requirements of the directive. The assessment must cover the design, the manufacturing and the operation of the safety component for lifts or lift and contain

    • a description of the safety component, including its area of use (in particular possible limits on speed, load and power) and conditions (in particular explosive environments and exposure to the elements); or, in case of lifts, a description of the model lift indicating clearly all the permitted variations of the model lift
    • design and manufacturing drawings or diagrams
    • explanations necessary for the understanding of those drawings and diagrams and the operation of the safety component for lifts (or lifts)
    • a list of the harmonised standards applied in full or in part the references of which have been published in the Official Journal of the European Union and, where those harmonised standards have not been applied, descriptions of the solutions adopted to enable the safety component for lifts to meet the conditions referred to in point 1, including a list of other relevant technical specifications applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied; and in case of lifts, also a list of the essential health and safety requirements taken into consideration, and a copy of EU declaration of conformity of the safety components for lifts incorporated in the lift
    • results of design calculations performed by or for the manufacturer or installer
    • test reports
    • a copy of the instructions for the safety components for lifts or, in case of lifts, a copy of the instructions referred to in point 6.2. of Annex I
    • steps taken at the manufacturing stage to ensure that series-produced safety components conform to the safety component examined,  in case of lifts, steps taken at the installation phase to ensure that the series-produced lift conforms to the essential health and safety requirements.

    The manufacturer of the safety component for lifts, the installer, or their authorised representative established in the European Union is requested to keep copies of the technical documentation for a period of 10 years after the last the safety component for lifts or lift is placed on the market.

    Affix CE marking

    Once the necessary steps have been successfully completed, the logo must be affixed to the product.

    The marking must be placed visibly and legibly on the product or, if not possible due to the nature of the product, be affixed to the packaging and the accompanying document. The CE marking shall consist of the initials 'CE' taking the following form:

    Affixing CE marking

    The various components of the CE marking must have the same vertical dimension and may not be smaller than 5 mm. If the CE marking is reduced or enlarged, the proportions given in the above graduated drawing must be respected.

    When the product is subject to other directives covering other aspects that also provide for the ‘CE’ marking, the accompanying documents must indicate that the product also conforms to those other directives.

    However, when one or more of those directives allow the manufacturer, during a transitional period, to choose which arrangements to apply, the ‘CE’ marking must indicate conformity only with the directives applied by the manufacturer. In this case, the particularities of the directives applied, as published in the Official Journal of the European Union, must be given in the documents, notices or instructions required by the directives and accompanying such products.

    The identification number of the notified body involved in the conformity assessment procedure must also be displayed.


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