CE mark is a symbol that manufacturers affix to certain products in order to be able to sell them legally in Europe. However, CE certification involves a lot more than just labelling the product.
How do you get CE certification?
If your products are subject to CE marking rules, you must follow six specific steps to CE marking compliance.
Step 1: Identify applicable directive(s) and standards
Different directives and standards may apply to your product. These are harmonised at European Union (EU) level and lay down the essential requirements (eg on safety) that your product has to fulfil. The CE marking process you must follow depends on which EU directives apply to your product.
Not all products require CE marking. Only products that fall under one or more of the European product directives are subject to CE marking rules. See products that need CE marking.
Step 2: Check the essential requirements for your product
Each directive outlines what the EU legally requires in order for your product to be compliant. It is up to you to ensure that your product conforms to the requirements. The directives don't tell you how you must achieve this. You can use harmonised standards (if they exist for your product) or choose other ways to fulfil the requirements set out in the directives.
STEP 3: Check if your product needs a third-party conformity assessment
Some directives require that an authorised third party, known as a notified body, tests and certifies your product in order to ensure conformity with the requirements. This conformity assessment procedure is not compulsory for all products. However, if you find that you need a notified body, use NANDO database to search by country and by directive.
Important: If the UK leaves the EU without an agreed deal, the EU will no longer recognise CE marking certification issued by UK-based notified bodies. To secure EU market access, you may need to transfer your certificate of conformity to an EU-recognised body. See status of conformity assessment bodies under no deal.
STEP 4: Test the product and check its conformity
Where it is not necessary to involve a notified body, you must rely on your own facilities to access your product's conformity. The directives outline which conformity assessments procedures - also known as modules - you can undertake.
STEP 5: Create and maintain technical documentation
All CE marking directives require manufacturers to create and make available technical documentation (ie a technical file) that shows the product's conformity to the requirements of the applicable directive. The kind of information that you have to keep, and the period you have to maintain it for, varies with directives and regulations. Examples of what is required may include a general description of the product, detailed drawings, a list of standards that apply, a copy of the risk assessment, copies of technical reports, instructions, the manufacturer's declaration, etc.
STEP 6: Sign the EU Declaration of Conformity and affix the CE mark
The final steps in the CE marking process include affixing the mark to your product and signing a Declaration of Conformity. The declaration acknowledges that the manufacturer is solely responsible for the compliance of their product with all applicable CE marking directives. See an example EU Declaration of Conformity.
The manufacturer (or their authorised representative within the EEA or Turkey) must affix the CE mark according to specific rules. Only after the mark is properly affixed, your product will be ready for the market. Find rules on using the CE marking.