• CE Marking and Product Lab Testing: A Complete Guide

    Posted on 17 Comments

    CE marking is mandatory when importing toys, electronics, eyewear, protective equipment, machinery and a range of other products to the European Union. In this guide, we explain why third-party lab testing is an essential part of the CE certification process.

    What is CE testing?

    CE marking is mandatory for products covered by one or more ‘CE marking directives’. Here are a few examples:

    • RoHS Directive
    • Low Voltage Directive
    • EMC Directive
    • Toy Safety Directive
    • Personal Protective Equipment Directive

    These directives provide general safety requirements applicable to the products. It’s then up to the company placing the product on the market (e.g. importing or manufacturing) to apply the relevant EN, IEC, and ISO standards to ensure that the product meets the requirements.

    CE testing essentially comes down to third-party lab testing for the sake of verifying compliance with applicable standards (e.g. EN 55035). That said, there is no such thing as a uniform ‘CE test’ or ‘CE testing standard’.

    Is CE testing mandatory?

    Third-party lab testing is not mandatory for most products that must be CE marked. However, the importer must still ensure that a certain product meets the requirements outlined in the applicable EU directives.

    In reality, very few importers, and their overseas manufacturers, have the necessary expertise and equipment required to verify if a product is compliant.

    As such, third-party lab testing is almost always a necessity when importing and selling CE marked products in the EU.

    How much does CE testing cost?

    The cost depends on the number of applicable directives and, by extension, the number of applicable EN, IEC and ISO standards. Lab testing costs are normally priced on a ‘per test’ basis.

    While there is no standard ‘CE testing cost’, these cost examples may still be useful:

    • Power Bank: USD 1500 to 3000
    • Electronic Component: USD 5 to 50
    • AC Adapter: USD 500 to 1000
    • Wooden toy: USD 400 to 600
    • Sunglasses: USD 400 to 600

    CE product testing

    How do I know which standards and tests apply to my product?

    You can either use a service like Productip.com or CE-check.eu or request a lab test quotation. As mentioned, lab testing costs are based on the number of required tests. Lab testing companies, therefore, tend to include a list of applicable standards in their quotations.

    Example

    Test Cost
    Directive 2011/65/EC RoHS XRF Screening USD 350
    Directive 2015/863/EU RoHS Phthalate Test USD 100
    Electromagnetic Compatibility (EMC) – EN 55032 / EN 55035 USD 400
    Total: USD 850

    Is a lab test report sufficient when selling CE marked products?

    Not at all. In addition to the test report, you must also issue a Declaration of Conformity and Technical File. The latter normally includes the following:

    • Design drawings/Technical drawings
    • Bill of materials
    • Packaging file
    • List of applicable EN/IEC/ISO standards
    • User manual
    • Risk assessment

    Note that the test report is often used as a support document to the technical file. The test reports serve as proof that your product is compliant with all applicable standards.

    Why do I need lab testing if my product is already CE marked?

    The CE mark alone is not sufficient to prove that a product is compliant with all relevant EU directives and standards. In fact, there are plenty of unsafe products manufactured outside Europe, carrying the CE mark, but failing to comply with even the most basic safety standards.

    Obviously, printing a CE mark doesn’t magically make a product safe.

    This is also why lab testing is necessary when importing both custom-designed (OEM) and factory designed products (ODM) from China, and other countries.

    Can I get a test report from my supplier?

    It’s possible, at least in theory, to use lab test reports held by the supplier. However, this is rarely a viable option for these reasons:

    1. It’s very rare that suppliers can provide CE test reports their own factory-designed products. If they do, they normally only have valid test reports for a limited number of SKUs.

    2. You cannot apply test reports from one product to another. As such, you cannot apply supplier test reports to a new OEM product that has previously not been produced.

    3. Using existing supplier test reports is risky even if a valid test report exists for the exact same SKU. The reason is that the supplier may change components and materials from one production run to another.

    4. Many supplier test reports held by manufacturers in China are issued by unknown lab testing companies. Such test reports can be impossible to verify.

    In short, there are few scenarios in which you can apply existing supplier test reports to both factories designed (ODM) products and custom-designed (OEM products). Still, many importers have a tendency to accept any test report provided by the supplier at face value.

    How do I check if a CE test report is valid?

    You can contact the issuing company (e.g. QIMA or Bureau Veritas) and request a test report verification. This is normally provided free of charge. Some testing companies also allow you to verify test reports directly on their website.

    What can happen if I don’t have a valid lab test report?

    Market surveillance authorities mainly request two documents from importers when performing compliance checks:

    • Lab test reports
    • Declaration of Conformity (DoC)

    Failing to provide a valid test report can result in a forced recall, meaning that you must stop selling your product immediately.

    Also, note that not just any test report is accepted at face value. The company name, product SKU, list of standards and other relevant information must all add up.

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    Disclaimer: The content on this website is provided for general information only. The content includes summaries written by our team members based on publicly available information about product safety standards, labeling, documentation, testing, processes, and other product compliance related topics. However, we don’t guarantee that we cover every single relevant regulation/standard/requirement, or that the information is free from errors, or covering every single scenario and exemption. We do make mistakes from time to time. We never provide legal advice of any sort.

    Changes/Updates: Product standards and substance restrictions are subject to frequent updates and changes. In addition, new regulations, standards, and/or requirements may also become effective at any time. We don’t update our articles whenever new standards/regulations/rules are added or changed. We recommend that you consult a lab testing company or other professional to get the latest information about mandatory standards/regulations in your market, country, or state. Lab testing companies generally stay up to date on new and updated standards and regulations.

    National/State-Level Standards/Regulations: Many articles don't cover all European national and US state standards, regulations, and requirements. We recommend that you consult a testing company or other professional to confirm all relevant (and current) national/state level standards and regulations.
  • 17 Responses to “CE Marking and Product Lab Testing: A Complete Guide

    1. Saba at 2:42 pm

      Hey,
      Can you send me the list of tests required for CE marking?

      1. Fredrik Gronkvist at 10:00 am

        Hi Saba,

        There is no such list. That depends on the applicable regulations/directives and by extension the applicable EN, IEC, and other standards.

        The EN standards and corresponding lab tests applied to a toy are very different compared to, say, a power bank.

        1. Saba at 6:22 pm

          And for medical devices as well. Right?

          1. Fredrik Gronkvist at 9:58 am

            We don’t cover medical devices

    2. kevin at 5:40 pm

      my supplier has recommended a lab, their certificate says they are CNAS and ILAC accredited, are there any more checks i need to do before using this lab? I tried using Qima, they quoted $1k then doubled it to $2k once receiving an expensive amount of samples.

      1. Fredrik Gronkvist at 11:05 am

        Hi Kevin,

        Not sure how relevant CNAS and ILAC are in this case.

    3. Rehan Qamar at 7:57 pm

      Dear Fredrik,
      It is stated that we are manufacturer of N95 Mask and we have tested our product is tested as per EN-149 standard. Now we want CE Certificate for our product. Please help us to apply CE certification of CAT-II N95 mask according to FFP2 class.
      your kind favour will be highly appreciated.

    4. Mohamed Ahmed at 7:39 pm

      Hello Sir,

      I need a quotation to get CE certification for NFC reader product.

      Also if you can provide FCC quotation for the same product it would be appreciated.

      Here are some details about the product:
      The product is NFC reader/writer with USB interface to PC
      Power Supply: USB powered
      Interfaces: 1 x USB
      Case: ABS plastic
      Dimensions: 80mm x 40mm x 12mm
      internal chipset: RFID chip coming from NXP and it is CE and FCC marked

      Regards,
      Mohamed Ahmed.

    5. Jennifer H at 9:47 am

      And if selling a bluetooth handsfree Item? I need the Bluetooth report from the Supplier?

      And I need to sign up on the bluetooth website for the free account?
      And then what document do I need to draw up for the supplier, Bluetooth Co. and I? Stating what?
      And am I aloud to have the bluetooth Logo on my website or marketing Material?
      and I do know that my product should be marked with the bluetooth symbol on the product and if not on the packaging forsure with the FCC and CE as well??
      And Does a Bluetooth Chip Roda 1536U have the same regulations as the Bluetooth speaker?
      Is it a real bluetooth Chip? And this might be a stupid question but if its not by Bluetooth then do I still need to go through Bluetooth or just the FCC and CE?
      Thanks!

      1. Fredrik Gronkvist at 11:35 am

        Hello Jennifer,

        Bluetooth is licensed technology. I know they charge fees, ranging from 2500 up to 8000 USD per SKU or something like that. Not sure if that only applies to the chip makers or also end products.

    6. John Percival at 10:00 pm

      Do you have a list of labs in the EU or UK that can do testing to EN14605?

    7. Venkat Iyer at 7:28 pm

      What are mandatory lab tests required for a dehumidifer which has CE Marking in order to meet Machinery and Low Voltage Directives

      1. Fredrik Gronkvist at 1:56 pm

        You need to ask a lab to help you assess applicable EN, IEC and ISO standards

    8. Maggie Ho at 4:37 pm

      So far as I read your articles and others in the internet, may you pls. clarify if there is an EU database which can check whether a manufacturer is qualified to affix CE mark ? Besides, is there an EU Authorised Representative which based in Asia ?

      1. Fredrik Gronkvist at 1:15 pm

        Hi Maggie,

        I don’t think this such a database exists. For most products, the CE mark is “self affixed”.

        No, I don’t think an EU authorized representative can be based in Asia, or anywhere outside the EU for that matter. That would defeat the entire purpose of having a European representative.

    9. MASSIMO at 7:16 pm

      Can you give me the company ho make CE test report for non medcical KN 95

      1. Fredrik Gronkvist at 7:18 pm

        KN 95 is a Chinese standard. It has nothing to do with CE marking.

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