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Frequently Asked Questions

CE Marking frequently asked questions

Still have questions regarding the CE marking of your products or installations or the conformity assessment procedures ?  Below are  frequently asked questions that are daily answered by our regulatory compliance engineers.  If you have any other questions which cannot be found on the list below ,  do not hesitate to contact our compliance experts. They will clearly indicate what the certification procedure is for your company.

Does my product need to comply with CE certification?

That depends on your product. There are CE guidelines and directives for a large number of product groups. If your product does not fall within the scope of one of these guidelines or directives, your product may not bear the CE-marking.

Even if your product does not fall within the scope of CE certification, the product must always comply with the specific product safety requirements. These depend on the type of product.

Would you like to know whether your product needs to bear the CE-marking, or which other product safety requirements apply? Then contact us. We would be happy to assist.

I wish to have my product CE certified, what do I need to do?

Product certification entails a number of steps:

  1. Does my product need to comply with CE certification?
    You first need to ascertain whether your product needs to comply with a CE guideline and/or directive. The answer can be found in the first FAQ.
  2. Determining the essential safety requirements for your product.
    The essential criteria that apply to the product are determined based on the established guidelines and/or directives. In most cases, standards are used to demonstrate that the product complies with safety requirements.
  3. Testing and/or inspection
    The product is tested or inspected based on the standards and/or other requirements.
  4. Preparing the technical documentation
    The technical documentation contains information that shows the product meets the applicable criteria. The content of the technical documentation is set out in the guidelines and directives and is therefore dependent on the product.
  5. Drawing up the declaration of compliance
    If you can demonstrate by means of the technical documentation that the product complies with the guidelines and/or directives, you can draw up and sign the declaration of compliance. The CE-marking may now be affixed.

Which guidelines, requirements and/or standards apply to my product?

In some cases, it is very obvious which guidelines apply to the product. In other cases, it requires research. This entails reading multiple guidelines to decide which best applies to the product. We would be happy to do this for you.

Once it has been established which guidelines apply, the essential requirements for your product can be determined. The standards can be established based on this. Note that these are not freely available.

The manufacturer has certified the product, can I offer the product to the European market on this basis?

That depends whether you are offering the product to the market as an importer or under your own name.

The importer must ensure the manufacturer has fulfilled its obligations. That means the importer is responsible for ensuring the product complies with European product safety requirements.

To demonstrate that the product complies, the importer must ensure the technical documentation is complete and correct. In addition, the importer’s name, registered trade name or trademark, as well as the postal address where the importer can be reached, must be shown on the product.

If you offer the product to the market under your own name, you are regarded as the manufacturer. In that case, you may, with permission, use the manufacturer’s documentation. You can only use this documentation if you are sure it is correct, this is your own responsibility. If you use the manufacturer’s documentation, the declaration must be in your own name.

If you use the manufacturer’s certification, the product may no longer be modified.
If you wish to be certain the documentation supplied by the manufacturer is complete and correct, we would be happy to check the documentation for you. You thus fulfill your obligations in full.

What is the cost of CE certification?

That depends on many factors. For example, specific tests that need to be carried out, whether or not by an accredited lab, the complexity of the product, whether the product can be shipped, whether the product already includes certified components, etc. We can provide a specific cost estimate in the form of a quote.

How long does CE certification take?

On average, certification takes six to eight weeks for a single product. This depends on the test results, whether the product still needs to be modified, and how quickly the technical documentation can be supplied. If it is urgent, we can fast-track the process, depending on the product.

How do I ensure my product meets all requirements worldwide?

There are no hallmarks that apply globally. If you wish to offer your product to the market worldwide, we can prepare a customized strategy. It is important that we start with the markings with the most stringent criteria.

What does the CE marking on a product indicate?
By affixing the CE marking to a product, the manufacturer declares on his sole responsibility that the product is in conformity with the essential requirements of the applicable Union harmonisation legislation providing for its affixing and that the relevant conformity assessment procedures have been fulfilled. Products bearing the CE marking are presumed to be in compliance with the applicable Union harmonisation legislation and hence benefit from free circulation in the European Market.
– Source: “European Commission
Is a product affixed with the CE marking always produced in the EU?
No. The CE marking only signals that all essential requirements have been fulfilled when the product was manufactured. The CE marking is not a mark of origin, as it does not indicate that the product was manufactured in the European Union. Consequently, a product affixed with the CE marking may have been produced anywhere in the world.
– Source: “European Commission
Are all CE marked products tested and approved by authorities?
No. In fact, the assessment of the conformity of the products with the legislative requirements applying to them is the sole responsibility of the manufacturer. The manufacturer affixes the CE marking and drafts the EU declaration of conformity. Only products which are regarded as presenting a high risk to the public interest, e.g. pressure vessels, lifts and certain machine tools, require conformity assessment by a third party, i.e. a notified body.
– Source: “European Commission
Can I, as a manufacturer, affix my products with the CE marking myself?

Yes, the CE marking is always affixed by the manufacturer himself or his authorised representative after the necessary conformity assessment procedure has been performed. This means that, before being affixed with the CE marking and being placed on the market, the product must be subject to the conformity assessment procedure provided for in one or more of the applicable Union harmonisation acts. The latter establish whether the conformity assessment may be performed by the manufacturer him- self or if the intervention of a third party (the notified body) is required.
– Source: “European Commission

Where should the CE marking be affixed?
The marking shall be affixed either to the product or to the product’s data plate. When that is not possible due to the nature of the product, the CE marking shall be affixed to the packaging and/or to any accompanying documents.
– Source: “European Commission
What is a manufacturer's declaration of conformity?
The EU declaration of conformity (EU DoC) is a document in which the manufacturer, or his authorised representative within the European Economic Area (EEA), indicates that the product meets all the necessary requirements of the Union harmonisation legislation applicable to the specific product. The EU DoC shall also contain the name and address of the manufacturer along with information about the product, such as the brand and serial number. The EU DoC must be signed by an individual working for the manufacturer or his authorised representative, and the employee’s function shall also be indicated. Whether a Notified Body has been involved or not, the manufacturer must draw up and sign the EE declaration of conformity.
– Source: “European Commission
Is CE marking mandatory, and if so; for what products?
Yes, CE marking is mandatory. However, only the products that are covered by the scope of one or more of the Union harmonisation acts providing for CE marking shall be affixed with it in order to be placed on the Union market. Examples of products that fall under Union harmonisation acts providing for CE marking are toys, electrical products, machinery, personal protective equipment and lifts. Products that are not covered by CE marking legislation shall not bear the CE marking. 26.7.2016 EN Official Journal of the European Union C 272/147  Information the products that are CE marked and the Union harmonisation legislation providing for CE Marking under http://ec.europa.eu/growth/single-market/ce-marking/index_en.htm
– Source: “European Commission
What is the difference between the CE marking and other markings, and can other markings be affixed on the product if there is a CE marking?
The CE marking is the only marking that indicates conformity to all the essential requirements of the Union harmonization legislation that provide for its affixing. A product may bear additional markings provided that they do not have the same meaning as the CE marking, that they are not liable to cause confusion with the CE marking and that they do not impair the legibility and visibility of the CE marking. In this respect, other markings may be used only if they contribute to the improvement of consumer protection and are not covered by harmonisation legislation of the European Union.
– Source: “European Commission
Who supervises the correct use of the CE marking?
In order to guarantee the impartiality of market surveillance operations, the supervision of the CE marking is the responsibility of public authorities in the Member States in cooperation with the European Commission.
– Source: “European Commission
What are the sanctions for counterfeiting the CE marking?
The procedures, measures and sanctions that apply to counterfeiting of the CE marking are laid down in Member State’s national administrative and penal law. Depending on the seriousness of the crime, economic operators may be liable to a fine and, in some circumstances, imprisonment. However, if the product is not regarded as an imminent safety risk, the manufacturer may be given a second opportunity to ensure that the product is in conformity with the applicable legislation before being obliged to take the product off the market.
– Source: “European Commission
What implications may the affixing of the CE marking have for the manufacturer/importer/distributor?
While manufacturers are responsible for ensuring product compliance and affixing the CE marking, importers and distributors also play an important role in making sure that only products complying with legislation and bearing the CE marking are placed on the market. Not only does this help to reinforce the EU’s health, safety and environmental protection requirements, it also supports fair competition with all players being held accountable to the same rules. When products are produced in third countries and the manufacturer is not represented in the EEA, importers must make sure that the products placed by them on the market comply with the applicable requirements and do not present a risk to the European public. The importer must verify that the manufacturer outside the EU has undertaken the necessary steps and that the documentation is available upon request. Thus, importers must have an overall knowledge of the respective Union harmonisation acts and are obliged to support national authorities should problems arise. Importers should have a written assurance from the manufacturer that they will have access to the necessary documentation — such as the EU declaration of conformity and the technical documentation — and be able to provide it to national authorities, if requested. Importers should also make sure that contact with the manufacturer can always be established.

Further along in the supply chain, distributors play an important role in ensuring that only compliant products are on the market and must act with due care to ensure that their handling of the product does not adversely affect its compliance. The distributor must also have a basic knowledge of the legal requirements — including which products must bear the CE marking and the ac- companying documentation — and should be able to identify products that are clearly not in compliance.

Distributors must be able to demonstrate to national authorities that they have acted with due care and have affirmation from the manufacturer or the importer that the necessary measures have been taken. Furthermore, a distributor must be able to assist the national authority in its efforts to receive the required documentation.

If the importer or distributor markets the products under his own name, he then takes over the manufacturer’s responsibilities. In this case, he must have sufficient information on the design and production of the product, as he will be assuming the legal responsibility when affixing the CE marking.   C 272/148 EN Official Journal of the European Union 26.7.2016
– Source: “European Commission

Where can I find more information?
Information about CE marking, the products that are CE marked, the Union harmonisation legislation providing for CE Marking and the steps to follow under http://ec.europa.eu/growth/single-market/ce-marking/index_en.htm Economic operators may contact the Enterprise Europe Network under http://een.ec.europa.eu/ 26.7.2016 EN Official Journal of the European Union C 272/1
– Source: “European Commission

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