Product displaying CE Certification Marking

When selling a product or piece of equipment in the European Union, you must determine if it requires a CE Marking, the formal name for CE certification. Several European laws mandate certain products carry the CE Marking.

The term “CE” stands for conformité européenne, which is French for European Conformity. When a product has a CE Marking, it is a symbol that it complies with all the applicable laws. If the regulations apply to your product, you can’t sell it or put it in service anywhere in the European Union without the CE Marking.

An example of a CE Marking can be found in the image to the right; it contains the stylized letters C and E. It is the EU market’s way of regulating goods sold in Europe and has been in place since 1985. While many people call it a “CE Mark,” the correct terminology is actually “CE Marking.”

What Does CE Marking My Product Indicate?

When your product has a CE Marking, you are legally declaring that:

  • It complies with all relevant product directives and regulations in the European Union
  • You have checked and identified all the laws that apply to it
  • It conforms to all of the applicable health, safety, and environmental laws
  • It is legally compliant enough to sell everywhere in the European Union
  • It meets the laws’ essential requirements, and you can prove it with documentation
  • You can provide the EU Authorities at their request with a legally correct and complete Technical File that demonstrates conformity
  • You have given a legal assurance, and you take full legal responsibility for any failings and their consequences

What Happens if I Don’t Secure a CE Marking?

If any relevant product regulations or directives in the European Union apply to your product, you must obtain a CE Marking, declaring its conformity to the relevant regulation(s) and directive(s). If you fail to secure a CE Marking, your product or equipment cannot be sold or used commercially in the European Union.

If you affix a CE Marking to your product or equipment and you fail to ensure your product has the proper CE certification, you can face harsh penalties ranging from steep fines to jail time. Your product can also be temporarily removed from service or impounded until improved. Your product may even be subject to a European Union-wide product recall. You are also responsible for any resulting costs.

Self Declaration vs. Certification from an EU-Notified Body

Most CE Marking is based on self-certification, only a very few aspects formally require you to use a special government-approved CE third party, called a Notified Body. An EU Notified Body is an organization that is accredited by the European Union to assess the conformity of certain products before they are eligible to be placed on the market. Technology International Inc is a fully accredited EU Notified Body located in the USA.

Self-certification requires a rigorous conformity assessment of your products against each applicable clause of each applicable regulation or directive. It also requires risk assessments, frequent standards assessments, and test reports. Once you’ve completed all necessary assessments, you must then issue a Declaration of Conformity (DoC), arrange any mandatory EU legal representation, and affix the CE Marking to your product.

While some choose self-declaration to save on the costs of working with a third party, most companies that don’t have extensive CE marking experience find significant benefits from being guided through the process by a CE Marking expert, since it is time-consuming, can be very exacting, and the penalties for misrepresentation are severe.

There are often many hidden costs in compliance work, particularly for CE Marking compliance. The overall cost of ownership can be significantly reduced by working with an accredited inspection body like Technology International. Having a CE Marking expert guide you through the process ensures that you are compliant with all relevant regulations and directives, equipped with the proper documentation, and able to avoid any unexpected costs by having to redo parts of the process or even making changes to your product or equipment.

Countries That Require CE Marking

CE Marking is required for relevant products sold in all member countries of the European Union (EU) as well as the non-EU EEA countries. Though not part of the EU or EEA, Switzerland and Turkey have adopted certain regulations and directives. The UK does not use CE marking, but has almost identical technical requirements – at least for now – and instead uses UKCA marking. That is not discussed further here. Current CE Marking countries are:

  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Czech Republic
  • Cyprus
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Liechtenstein
  • Luxembourg
  • Malta
  • Norway
  • The Netherlands
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • Switzerland
  • Turkey

When an inspection body is “notified”, it is accredited by the local national authorities and that accreditation is shared with the European Commission (EC), the legislative head of the European Union (EU). So you will sometimes see EU or EC notified body used, They are the same thing. In addition to Technology International being an EC-accredited Notified Body, we are a UK-accredited Approved Body UKCA Marking too.

Additional Facts about CE Marking

  • If the law requires your product to carry the CE Marking, it is illegal to sell the product or put it into service without the CE Marking
  • It is unlawful to affix the CE Marking incorrectly
  • There is no alternative qualification to CE in the European Union, EEA, Switzerland, or Turkey
  • CE is entirely different from US and Canadian requirements: US and Canadian qualifications and certificates don’t satisfy CE requirements in any way, nor vice-a-versa

How do I Get a CE Marking on My Product?

You will need to take four primary steps once you’re ready to get a CE Marking for your product.

Identify what legislation applies to your product

Most, but not all, manufactured products fall under one or more of the CE Marking regulations or directives. There are multiple laws with frequent updates, additions, and modifications. All details can be found on the European Commission Website.

Show your product satisfies the legal requirements

You need to assess your product against the requirements of the relevant regulation(s) and directive(s). To demonstrate conformity to some of the legal clauses, you may choose to show compliance to certain “harmonized” European standards. Under particular circumstances, you may be additionally required to have your work checked and certified by an accredited Notified Body. In many cases, it may be optional to have a Notified Body certify your work. Most of the products that require certification from an EU Notified Body are products to which the Radio Equipment Directive, ATEX Directive or Pressure Equipment Directive are applicable; these products often require additional testing and documentation (Type Examinations) to be done by an EU Notified Body.

Declare Conformity

Draw up and sign a legal declaration that your product conforms to all applicable regulations and directives. This is an easy step, but with huge consequences–so be sure you know legally what you are doing. You are effectively signing a contract with all European Governments that require CE Marking compliance.

Apply the CE Marking

Affixing the stylized CE letters to your product is a legal claim that you have done the previous three steps and that your product conforms to all applicable laws. Like Step 3, this is effectively signing a contract.

How Long Does it Take to Obtain a CE Marking?

It can take anywhere from two weeks to two or three months to go through the CE Marking process in most cases, but sometimes it can take as long as years with very large and complex projects, and rolling installations.

The stages of CE Marking are:

  • Legislation identification
  • Product compliance
  • Technical documentation
  • Apply CE Marking
  • Placing the product on the market

During the technical assessment, deficiencies may be found in the product. You will need to address these. Any required retests will delay the process. There are also associated costs in remediating your product’s non-conformities. This is why it pays to work with the experts at Technology International. We have the experience and know-how to guide you through this often-complicated process.

If you are installing complex gear such as production lines, process plants, or other facilities subject to CE marking, the CE Marking needs to cover the equipment as installed and integrated, so assessing the product compliance refers to the final “as installed” product. When multiple parties are involved from multiple companies in different countries, and a flurry of contracts cover all the details, figuring out where the various responsibilities start and stop can become tricky. This is where Technology International has deep expertise, with years of figuring this stuff out so you don’t have to. We have large-program experience in aerospace, energy, water, semiconductor, automotive, warehouse automation, and general manufacturing to name a few.

CE Marking vs. CE Certified

The general term for following the process required by the CE Marking laws is CE Marking: a verb. The stylized symbol CE that gets put on the product after the process is complete is also called a CE Marking: a noun. The words CE-certificate, CE-certified, CE-certification, and related do not formally exist. They are simply common terms for the different aspects of CE Marking, but they are incorrect. “CE certificate” is a common misnomer for a Declaration of Conformity.

In cases where an EU Notified body gets involved, they conduct an exercise formally called an “EU [or EC] Type Examination” (EUTE or ECTE), and they produce an EUTE Certificate. That is not the same as or a substitute for the Declaration of Conformity.

How Much Does CE Marking Cost?

Many factors impact the overall total cost of obtaining a CE Marking for your product:

  • What is your product and what laws apply to it?
  • At what stage of development is your product when you start the CE marking process?
  • What standards do you need or want to use to demonstrate conformity?
  • Have you designed the product explicitly to meet those laws or standards?
  • What is your design practice like – how close is your design naturally to those laws and standards?
  • What quality of parts and components have you used – will they satisfy those laws and standards?
  • Do the parts and components have CE Markings themselves? Or, are they of poor quality and likely need to be replaced?
  • How mature is your design – is CE going to find big or small gaps in the design?
  • What is the product’s history like – is CE going to find a history of accidents implying extensive upgrades?
  • How complex is the product? Typically, the more complex the product, the more time and testing required.
  • What is your organization like – if CE compliance requires significant updates to the product or equipment, then what?
  • What level of quality management does your organization have – do the drawings match the build?
  • What are your contractual terms with your client? If CE compliance requires changes to your product or equipment, how will that impact your current business relationships?
  • What timescales do you have – if those changes are going to take weeks, are there damage clauses to consider?
  • What is your supply chain like – even if the change is easy, can you get the parts on time?
  • What is your staffing like vs your commitments – do you have folks available to make the changes, and at what rates?
  • What’s the sticker price for Technology International’s support?

The list is almost endless, and that’s just getting to the CE Marking. The vast majority of costs of CE marking come down to your company’s business situation and the nature of the product, not third parties or testing costs. If you leave CE marking to the last minute or as an afterthought, it is likely to cost you vastly more than if you address it early on. Say you make two left shoes. If you catch it at the start, you just click the flip button in CAD. If you wait until the end, you have to throw one away and start again from scratch. Technology International’s assessment costs don’t matter to you at that stage…

Part two of the cost is after it goes on the market. You are on the hook for ten years as the manufacturer. Any incident in the first ten years of the product’s operation is potentially on you. Your project manager may be happy and long gone, the project delivered, but if he or she cut corners and someone gets hurt 8 years later, the project might suddenly end up as a court case costing 100 times what you thought you’d made on it all those years ago… Wise folk factor that into their business case, and call Technology International at least for a quote!

Trust Technology International with Your CE Marking Needs

At Technology International, we are CE Marking experts with over 30 years of experience providing CE Marking services to thousands of companies. The CE Marking process is very technical and rigorous and can have severe consequences when not done properly. We can guide you through the entire process to ensure your compliance with all relevant regulations and directives so you can sell your product or equipment in the European Union with peace of mind. Click the button below to start the CE Marking process or to hear from one of our experts.


Helpful Resources

Click one of the resource links below to learn more about the CE Marking process.