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CE-Marking - The Ultimate Guide (2022)

23/04/2021 Ferry Vermeulen Law & Legislation

What Are the CE Certification Costs?

That is a very tough question to answer, but let's give it a try.

CE certification costs can vary from below $ 100 to over $100,000. The CE marking costs totally depend on the kind of product and the certification procedure to be followed.

The certification procedure, or procedures, that apply, is based on the intended use and the technical specifications of a product.

As 90% of all products can be certified without a Notified Body (NoBo), in many cases you won’t need third party testing. This will be a massive cost saver.

As quite a lot of conformity assessments are visual inspections, without the need of special testing equipment, these visual checks can be done by yourself.

When you build your technical file yourself and when you can conduct all testing yourself, you will also save quite a lot of money.

When you outsource the testing, without the need of a NoBo, you will at least have to pay for the testing costs.

Also, some testing might have been done by the supplier or by the manufacturer of components. In those cases, a certain amount of testing can be skipped; sometimes, after validation of the supplier’s documentation.

For example, when you manufacture a product that contains a Bluetooth module that already has been tested and CE approved, you don't need to do the testing all over again.

The possible costs of CE marking in an overview:

  • CE consultant
    • General guidance/support
    • Determining directives and standards
    • Conformity assessment
    • Compiling the technical file
    • Check compliance and completeness of technical files/tes reports done by the manufacturer.
    • Risk analysis
  • Testing done by the testing lab
  • Notified Body for conformity assessment
  • Creating the user manual

A testing lab might charge you everything starting at $100 to test if a product complies with a standard. Certification of a complete production line can cost over $100,000.

The time that consultants, test labs or notified bodies need to spend on your product and/or technical file, will determine the largest part of the total cost of CE marking. Do you think that more than a day is needed for testing, conformity assessment, risk analysis, compiling the technical file etc? Then multiply the estimated hours with a reasonable hourly fee of a legal expert, to conclude that the cost of CE marking is likely to exceed $ 1500.

In order to determine the exact costs of CE marking, you first need to determine the following:

  • Which CE directives or regulations apply to your product?
  • Which (harmonised) standards apply to your product?
  • Which certification procedure(s) apply/applies?

Once this is known, you can collect and compare quotes from test laboratories, consultants, notified bodies and user manual service providers.

Does Amazon Require CE Marking?

Ecommerce platforms in general, and specifically Amazon, are more and more taking your responsibility when it comes to product safety seriously. Why?

Because when you for example import products from Asia and sell them on Amazon, you are fully responsible for making sure that your products comply with all mandatory safety requirements.

These include requirements on the packaging, labelling, technical file and declaration of conformity.

The person or company that places a product on the European market, and not the supplier, is responsible for the product.

Certain products are classified by Amazon as requiring “pre-approval”. Product groups that need pre-approval include, but are not limited to, kitchen equipment, toys, lighting, batteries and chargers.

For these product groups, Amazon requires you to upload the Declaration of Conformity before the product can be sold.

A team of Amazon’s product compliance experts will then manually check if your declaration complies with the European requirements.

Make sure you have completed the full CE marking process before you draft and sign the declaration of conformity.

By signing the declaration, you declare that the product meets all European requirements and you will be held liable for the product.

You should take the following steps:

  1. Identify applicable directives and standards
  2. Identify all applicable requirements
  3. Determine if third party testing is needed
  4. Conduct the conformity assessment
  5. Create the technical file
  6. Draw up and sign the declaration of conformity

The CE Marking Logo (Free Download CE Mark Logo)

The last step of the CE marking process is affixing the CE mark to the product.

The individual directives have requirements on the CE mark. In general you should make sure that:

  • The initials ‘CE’ are in the standard, predefined form
  • The CE marking has a height of at least 5 millimetres.
  • The CE marking is placed onto the product or to its data plate. When the size of the product does not allow this, the marking can be placed onto the packaging or in accompanying documents, such as the user manual.
  • The CE marking is easily visible, readable and permanent.

Download the CE mark logo here. 

Conclusion

So do you want to CE certify your products to sell on the European market?

In this article I have discussed some of the most relevant CE marking topics.

By now you should know is CE marking is mandatory for your product. You know where you can sell your product as soon as you comply and you know what your responsibilities are.

Summarised, in order to sell your product legally on the European market, you should follow the steps of the CE marking process.

For more information, listen to this podcast on How to CE mark a product.

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