Conformité Européenne (CE) marking is the European Union’s required certification for products, equipment and machinery supplied to European Economic Area (EEA) markets.
Although in the UK, UKCA marking came into effect on January 1st, 2021, the UK Government has released legislation that allows CE marking to be recognised indefinitely for products supplied to GB markets.
The manufacturer or, if applicable, the importer or distributor in those countries is entirely responsible for securing CE marking and affixing it to the product.
This involves the initial conformity assessment, setting up the technical file, issuing the Declaration of Conformity (DoC), and placing CE marking on the product.
In this guide, we’ll outline the six key steps required for CE marking compliance.
Download our free UKCA and CE Marking Guide here.
Step 1: Identify the Directive that applies to your product
The first step is to identify the specific EU regulations and standards relevant to your product type. These directives specify the key requirements that your product must satisfy.
To do so, we recommend reviewing the official safety guidelines for your product on the GOV.UK website here.
If you supply capital equipment to high-technology industries, such as semiconductor and pharmaceuticals, your product may fall under the Electromagnetic Compatibility Directive, Machinery Directive or Low Voltage Directive, among others.
It may be helpful to consult with industry experts or regulatory professionals to ensure you fully comprehend the regulations and directives that apply to your product, equipment or machinery.
Unsure if your product, equipment or machinery is covered by CE marking? Find out here.
Step 2: Verify whether you need an independent conformity assessment
Depending on your product and the applicable directives, you may need to either conduct a third-party conformity assessment through a notified body or self-declare compliance.
Self-declaration means that, as the manufacturer, you take full responsibility for declaring that your product meets the required standards and regulations.
For higher-risk products (such as medical devices, pressure equipment, and appliances using gaseous fuels), self-declaration is not permitted, and a third-party conformity assessment is generally required. In this case, you'll need to find an EU-authorised notified body to perform the assessment.
Step 3: Test your product for conformity
Test your product, equipment or machinery for conformity with the identified directives.
These tests should include:
- Evaluating your product’s design and specifications against the applicable regulatory requirements to ensure it meets the specified health and safety standards.
- Verifying that all materials used in your product comply with relevant regulations, particularly if certain substances or chemicals are restricted.
- Conducting functional tests to confirm that your product operates as intended and meets safety standards—this may include testing under different conditions to simulate real-world use.
- Carrying out risk assessments to identify and address any potential hazards associated with your product.
- Reviewing design and manufacturing documentation to ensure compliance with the regulations.
If any non-conformities are discovered during testing, you must take corrective actions to resolve them. This may involve modifying the product design, adjusting manufacturing processes, or updating the documentation.
At IES, we can test high-technology equipment against the following Directives:
- EMC (Electromagnetic Compatibility) Testing
- Machinery Safety Testing
- Electrical Equipment Safety Testing
Step 4: Prepare technical documentation
To demonstrate CE compliance, you must create and maintain technical documentation that shows your product, equipment, or machinery meets the applicable EU directives and standards.
This documentation usually includes details on the design and manufacturing process of your product, evidence of its conformity with the relevant requirements, safety inspection reports, and test certificates.
It’s also your responsibility as the manufacturer to draw up your EEA Declaration of Conformity (DoC). This serves as a formal declaration that you’ve met all requirements and safety directives applicable.
Step 5: Apply the CE marking
After your notified body completes the conformity assessment or you make your self-declaration, it's time to apply the CE marking to your product.
As the manufacturer, it’s your responsibility to place the mark.
You should apply it directly to the product, but you may also place it on its packaging, manuals, or any related materials, depending on the specific directives relevant to your product.
Use of the CE marking image is subject to the following rules:
- If you adjust the size of the marking, ensure it maintains the proper proportions as shown in the official version.
- The CE marking must be at least 5mm in height, unless otherwise specified in the applicable directives.
- The marking can vary in form but must always be clearly visible and legible.
Once the CE mark is applied, you can place your products, equipment, and machinery on the GB market.
Achieve CE marking compliance with total confidence
Our start-to-finish CE marking service covers every step of the compliance process, from assessing and testing high-technology equipment against specific directives to providing a Declaration of Conformity to aid self-declaration.
- Specialists with 30 years’ experience in compliance testing
- On-site assessments across the UK and Europe
- LVD, machinery directive and EMC testing
