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    Welcome to 360 Compliance
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    Major changes to CE Marking in April 2016

    March 16, 2016
    Global Market Access

    Are you ready for the 19th April? Are you confident that you have made all the changes required to ensure that your CE Marking remain valid?

    A New Legislative Framework (NLF) will get into force as from April 19th and will affect manufacturers responsibilities in the EU union.
    An explicit requirement is that all members of the supply chain ( Manufacturer, Authorized representatives, Importers, Distributes) have a duty of responsibility and Declaration of Conformity (DoC) alone will no longer be valid.

    For example, are you aware if the new EMC Directive 2014/30/EU affects you? After April, the new directive will be required for all EMC compliance files, and declarations referencing 2004/108/EC will no longer be valid.

    The nine directives which are due to come under alignment are:

    • Electromagnetic Compatibility Directive: 2004/108/EC
    • Low Voltage Electrical Equipment Directive: 2006/95/EC
    • Measuring Instruments Directive: 2004/22/EC
    • ATEX” Directive: 94/9/EC
    • Civil Explosives Directive: 93/15/EEC

    Whilst these directives may only be changing from an administrative perspective (rather than a technical one), manufacturers and the supply chain must, at an absolute minimum, update their documents and CE markings.

    DEMAND:

    CE Marking is a mandatory requirement in order to sell in the European Union.
    In order to bear the CE marking on a product, manufacturers must comply with all relevant Directives under the New Approach requirements and declare on it.
    Major Directives for Hi-Tech manufacturers are:

    • EMC (Electromagnetic Compatibility Directive: 2004/108/EC)
    • Electrical Safety (Low Voltage Electrical Equipment Directive: 2006/95/EC)
    • Radio Equipment Directive (RED) (2014/53/EU)
    • Restriction of the use of certain hazardous substances (RoHS): 2011/65/EU
    • Chemical substances (REACH) (EC) 1907/2006
    • E-Waste (WEEE, Packaging, Batteries)

    OUR SERVICES:

    Testing & Certification

    • EMC/ EMI Testing & Certification (FCC Part15, CE, VCCI..)
    • Electrical Safety Testing & Certification (UL/IEC/EN 60950)
    • Wireless Testing & Certification (FCC Part15, MiC, CE, IC..)
    • Mobile Operators approvals (PTCRB, GCF, Verizon, AT&T)
    • IT security (FIPS 140-2) Testing & Certification
    • Sustainability Testing & Certification (RoHS, Prop65, REACH, CPSIA..)
    • E-Waste Legislation frame work and ocal rep over Europe
    • Explosive Atmosphere (ATEX, HazLOc) Testing & Certification
    • Prepartion for Factory & Quality audits for ISO 8079-34 & NRTL
    • Homologation Type Approvals in 196 countries
    • Project Management in outsourcing from Start to End

    Compliance Strategy

    • Initial Technical Assesment
    • Standards choice & Test Plan – Compliance Strategy
    • Identification of non compliance Issues
    • Gap assesement: Design vs. Compliance
    • Gap assesement for previously certified product
    • Gap assesement for Critical Components
    • Market Research
    • Laboratories Technical Compliance Bidding
    • Customized Strategy approach for your compliance needs

    WHY US?

    360Compliance provides full turn key solution from Start to End for all compliance aspects relates to Electronic devices Including Testing, Certification, Project Management and Consulting minimizing your costs and shorten time to market.

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