Harmonized standards and European Directives for CE marking

Harmonized standards and European Directives for CE marking

What are harmonized technical rules?

The harmonized standards are standards in which it is described how to verify the requirements laid down by the directives in the field of security, health and environmental safeguard.

Who harmonized standards are developed?

The harmonized technical standards are developed by European Standardization Bodies: CENELEC for the products of the electrical / electronic compartment, FIND for products in telecommunications, CEN for the products of other sectors.

What it is determined in the harmonized standards?

Harmonized standards determine the suitability of a certain method of verification to assume that the product complies with the Directive.
These standards are called "harmonized", when their references are published in the Official Journal of the European Communities (GUCE) in relation to a directive.

The full application of harmonized standards allows the manufacturer to place the product on the market without previously subjecting the technical construction file to a notified body.
This allows for, independently, the CE certification of products and the drafting of EC declaration of conformity.
The producer who is suitably equipped can perform the tests in its own laboratories or they will turn to a referral laboratory.

The EC Directives have compulsory nature?

Yup, Directives are mandatory. The manufacturer (if the product is manufactured in the EEA – European Economic Area) or importer (if the product is manufactured outside the EEA) It is obliged to draw up a technical file for CE marking containing the tests to which the product has been subjected.
The tests are specific to each product category and the technical file must be shown on request to the national supervisory authorities.

The EC standards are voluntary?

the term “volunteer” there is still confusion.
The EC Directives do not make it mandatory to adopt the harmonized standards, however it is always necessary to prove the compliance of the product with the requirements of the directives applicable to the product.
You can in fact choose other technical and procedural solutions to comply with the essential requirements set out in Directives. These solutions typically require more in-depth technical assessments and the involvement of a Notified Body. Although most challenging, the latter is the only feasible in the case of products which due to their technical characteristics can not be evaluated by applying to the entire harmonized standards.

When you contact a Notified Body?

The intervention of a notified body is required when all the applicable harmonized standards are not executed in full. The costs in this case are more especially because the test methods outside the standard should be evaluated in advance, developing and developed.

What is the fastest route to get the CE mark?

The quickest route, less expensive and more tutelante for the producer is the full adoption of all harmonized standards applicable to the product, In fact, these are the "recipe" developed and tested over time to verify that the product conforms to the requirements of the directives.

Sicom Testing It offers a complete service for CE marking products.

To request more information on this topic, write to info@sicomtesting.com
or call +39 0481 778931.

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16 thoughts on “Harmonized standards and European Directives for CE marking”

  1. Good morning,

    once identified the Directive (or directives) applicable to a product as can be traced back to the harmonized standards relating to the Directive?

    • Good morning Alessandro,
      thanks for contacting us.
      The harmonized standards relating to directives are published in a list in the European Official Journal. The lists are available online on the Commission website.
      Sicom testing can help you identify the rules applicable to the product and perform the tests. To receive a quote can write here https://www.sicomtesting.com/richiesta-di-preventivo/.
      Sincerely
      Staff Sicom

  2. Good morning,

    I wanted to ask a question about the updating of harmonized standards. In particular the Machinery Directive. How can I check a possible update of the list? To date it should apply as published in the Gazette on 09/03/18. How can I check if you have run the updates to that list?

  3. I have a special product (plug-socket). But there is no harmonized or local standard for this. The product voltage is 220-240 V. If I simply apply the Annex I of the LVD, This is sufficient for the CE mark?

    • Good morning Serkan,
      plugs and sockets for domestic use are excluded from the scope of the LVD, as described in Annex II. However, if your product is intended for industrial use and / or powered in some way, It should be tested to verify its compliance with the applicable requirements. For more information, write to info@sicomtesting.com
      Kind regards
      Staff Sicom

    • Hello Sergio.
      The involvement of the Notified Body is indeed mandatory in cases prescribed by the Directives. However, for products that go beyond the cases expressly indicated, the intervention of a Notified Body is necessary if they have not been applied in full harmonized standards.
      Sincerely
      Staff Sicom testing

  4. Hello,

    am I right with the assunption that a new or revised standards can be counted as harmonized once published by one EU member state ?
    Is there a reliable statement about this which can be cited ?

    • Good morning,
      a harmonized standard can be considered as such when published in the EU Official Journal.
      Sincerely
      Staff Sicom Testing

      • Hello,

        agree.
        But I think it is possible to adopt a new or revised standard once published by national standard organisation in one EU member state even if the standard or its revision is not yet listed in the OJ of the EU? Being an early adaptor fulfill the requirement to design products according to latest technical developments (state-of-the-art). Or, theoretically, can I get problems if I list up standards not yet listed in the OJ ? Basically I’m free how to demonstrate compliance. I need to be able to explain my approach. State-of-the-art approach is a good argument, isn’t it ?

        • Good morning,
          in this case, in general, We need to involve a Notified Body in Product Certification.
          Sincerely
          Staff Sicom Testing

  5. Good morning,
    EN 16012/2015 It is a European standard but it is not a harmonized standard as it does not appear in the list of harmonized standards. What does it mean?

    • A standard svilupato is to create a common understanding of some aspect of the product. For example dimensional aspects, aspects of quality or safety aspects.
      These standards can be used to adjust for the sale or to declare the type or quality of a product to the customer.
      Some standards are assessed capable of demonstrating the compliance of a product with the requirements of a European directive, in these cases are included in the list of harmonized standards that Directive.
      To date, EN standard 16012 It is not harmonized standard, so it can not be used alone to demonstrate the conformity of a product with the requirements of Directive.
      good job
      Sicom Testing

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