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    Ce Marking Directives

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    ALOKE GANGULY
    CE marking indicates that a product has been assessed and deemed to meet EU safety, health and environmental protection requirements. It is required for products manufactured anywhere in the world that are then marketed in the EU. To apply the CE marking, manufacturers must demonstrate that their product complies with all applicable EU directives through testing and documentation in a technical file. Some high-risk products also require assessment by a notified body.

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    Ce Marking Directives

    Uploaded by

    ALOKE GANGULY
    45 views3 pages
    CE marking indicates that a product has been assessed and deemed to meet EU safety, health and environmental protection requirements. It is required for products manufactured anywhere in the world that are then marketed in the EU. To apply the CE marking, manufacturers must demonstrate that their product complies with all applicable EU directives through testing and documentation in a technical file. Some high-risk products also require assessment by a notified body.

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    CE MARKING DIRECTIVES

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    CE MARKING DIRECTIVES

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    CE marking indicates that a product has been assessed and deemed to meet EU safety, health and environmental protection requirements. It is required for products manufactured anywhere in the world that are then marketed in the EU. To apply the CE marking, manufacturers must demonstrate that their product complies with all applicable EU directives through testing and documentation in a technical file. Some high-risk products also require assessment by a notified body.

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    45 views3 pages

    Ce Marking Directives

    Uploaded by

    ALOKE GANGULY
    CE marking indicates that a product has been assessed and deemed to meet EU safety, health and environmental protection requirements. It is required for products manufactured anywhere in the world that are then marketed in the EU. To apply the CE marking, manufacturers must demonstrate that their product complies with all applicable EU directives through testing and documentation in a technical file. Some high-risk products also require assessment by a notified body.

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 3

    CE Marking

    GURANTIED QUALITY

    Many products require CE


    marking before they can be sold
    in the EU. CE marking indicates
    that a product has been
    assessed by the manufacturer
    and deemed to meet EU safety,
    health and environmental
    protection requirements. It is
    required for products
    manufactured anywhere in the
    world that are then marketed in
    the EU .

    QCS MANAGEMENT PVT LTD. +918697724963, [email protected] , www.qcspl.com


    CE Marking

    What are the directives that allow for CE


    Marking?
    Any product that is classified under CE regulations( European health, safety & environmental
    legislations) , must bear CE mark before placing it within the EEA market. Not all Products
    need to have the CE Mark . The products which need to bear the CE marks are as follows;
    1. Active implantable medical devices
    2. Appliances burning gaseous fuels
    3. Cableway installations designed to carry persons
    4. Eco-design of energy related products
    5. Electromagnetic compatibility
    6. Equipment and protective systems intended for use in potentially explosive
    atmospheres
    7. Explosives for civil uses
    8. Hot-water boilers
    9. Household refrigerators and freezers
    10. In vitro diagnostic medical devices
    11. Lifts
    12. Low voltage
    13. Machinery
    14. Measuring instruments
    15. Medical devices
    16. Noise emission in the environment
    17. Non-automatic weighing instruments
    18. Personal protective equipment
    19. Pressure equipment
    20. Pyrotechnics
    21. Radio and telecommunications terminal equipment
    22. Recreational craft
    23. Safety of toys
    24. Simple pressure vessels

    What should be the content of “Technical


    Construction File” (TCF)?
    Generally the technical file requires the following things:
    1. Description of the product
    2. Conceptual Drawing, Component Drawings etc
    3. Result of Risk Analysis
    4. Test Reports against applied Harmonised EN Standards
    5. Labels
    6. Instruction for Use
    7. Signed “Declaration of Conformity”(DOC)

    QCS MANAGEMENT PVT LTD. +918697724963, [email protected] , www.qcspl.com


    CE Marking
    Can you claim CE Marking without testing
    your product?
    No. Annex IV of LVD Directive and EMC Directive and Annex VII of the Machinery
    Directive clearly asks for test report as a part of the Technical File.

    CE Marking Process
    Application Review & Certification Contract> Determination of applicable directives &
    harmonised standards > Determination of applicable conformity assessment route >
    Products testing>
    TCF-Technical Construction File > DOC – Declaration Of Conformity.> Self Certification /
    Notified body assessment > affix CE mark on products> Post Market Surveillance.

    Do you need an independent assessment?


    You need to check if your product has to be tested by a notified body. You can find this
    information in the relevant legislation applicable to your product: check the rules by product
    category. This step is not obligatory for all products.

    If you need to involve a notified body, the CE marking must be accompanied by the
    identification number of the notified body. The CE mark and the identification number can be
    affixed separately, as long as they appear clearly linked to each other.

    You can use the Nando database to search for a notified body that can certify your product.
    If your product doesn’t need to be verified by an independent body, then it is up to you to
    check that it complies with the technical requirements. This includes estimating and
    documenting the possible risks when using your product.

    How can we help ?


    QCS accredited by EUAS USA against ISO 17065 (Products Certifications standard) and our
    partner Euro-Tech group hold various accreditations such as ESYD Greece, UKAS ,
    approved notified body (NB1128) and NABL, provide the following services to demonstrate
    conformity of products against various EU regulations ;
     Determine the regulations & harmonised standards applicable to the product’s
    category
     Determine the conformity assessment route (voluntary or notified sector) as per the
    regulation
     Test products as per the EN harmonised standards from NABL authorised
    laboratories
     Preparation of TCF and DOC
     Assessment by an independent third party notified body ( in notified sectors ) or
     an independent assessment to guarantee the Quality safety and security of products(
    in voluntary areas)
     Appointment of European representative
     Affix CE marking on your products.

    QCS MANAGEMENT PVT LTD. +918697724963, [email protected] , www.qcspl.com

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