How to get CE marking for your product
Prepare your product’s compliance steps before placing it on the European market
Are you developing, importing or selling equipment intended for the European market? The CE marking process starts with identifying the requirements that apply to your product. It then covers the conformity assessment, the preparation of technical evidence and the formalities required to place the product on the market.
The Emitech Group supports you in defining this approach, preparing your tests and building the evidence for your demonstration of conformity.
Who is responsible for CE marking?
The manufacturer bears primary responsibility for the product’s conformity. Other economic operators also have obligations, depending on their role and the applicable legislation.
The manufacturer
The manufacturer designs and manufactures a product, or has it designed or manufactured, and markets it under its own name or trademark. It organises the conformity assessment, draws up the technical documentation, draws up and signs the required declaration, and ensures that the CE marking is affixed.
The importer
Established in the European Union, the importer places on the market a product from a third country. It checks that the manufacturer has fulfilled its obligations: assessment procedure, technical documentation, marking, traceability and instructions for use in the required languages. It indicates its own name, registered trade name or trademark and address on the product or, where this is not possible, on its packaging or in a document accompanying the product. It must be able to have the necessary documents made available to the authorities.
The distributor
Before making a product available on the market, the distributor carries out the required checks on the marking, the documents and the identification of operators. Storage and transport conditions must not jeopardise conformity. A product it considers non-compliant must not be made available until it has been brought into conformity.
The authorised representative
Established in the European Union, the authorised representative performs the tasks specified in a written mandate from the manufacturer, in particular making documents available and cooperating with the authorities. The mandate cannot cover the product’s compliant design or the drawing up of the technical documentation, which remain the manufacturer’s responsibility.
Own brand or modification: when do you become the manufacturer?
An importer or distributor that places the product on the market under its own name or trademark, or modifies a product already placed on the market in such a way that its conformity may be affected, is considered a manufacturer and takes on the manufacturer’s obligations. This point should be examined before marketing a white-label product or modifying a product.
Manufacturer established outside the European Union?
For many products subject to CE marking, in particular under the EMC, Low Voltage, RED and Machinery directives, Regulation (EU) 2019/1020 requires an economic operator established in the Union to be identified for the product: manufacturer, importer, authorised representative or fulfilment service provider. Its contact details must appear on the product, its packaging, the parcel or an accompanying document.
Using a laboratory or a notified body does not release any operator from its obligations.
Steps to prepare your CE marking
01
Check whether your product is subject to CE marking
Start by clarifying your role: manufacturer, importer, distributor or authorised representative. Marketing a product under your own brand or modifying it may mean you take on the manufacturer’s obligations.
Not all products must bear the CE marking. Determine whether your equipment falls within the scope of one or more pieces of EU legislation that require it.
Its function, intended use and users.
Its operating environment and electrical characteristics.
The presence of radio functions or specific components.
Whether it is marketed as a finished product, a component or an assembly.
Describing the product precisely makes it possible to define the scope of the process from the design stage.
Identify the requirements with our regulatory engineering team
02
Identify the applicable legislation and standards
Requirements relating to electromagnetic compatibility, electrical safety or radio equipment must be examined where relevant. Several regulations may apply to the same product.
Harmonised standards can facilitate the demonstration of conformity with the requirements they cover. Their relevance, version and status must be checked for the product concerned.
Explore the requirements specific to your equipment:
EMC Directive Low Voltage Directive RED Directive
Machinery Medical devices (MD) and IVDs
03
Define the conformity assessment procedure
The procedure depends on the applicable legislation and the product’s characteristics. It determines the assessments, the supporting evidence and the possible involvement of a notified body.
Such involvement is not systematic. Check which procedures are permitted or required before starting the project.
Understand the role of Emitech Certification
04
Prepare the necessary assessments and tests
The assessment plan turns requirements into concrete checks. It specifies the tests, the product configurations to be examined and the documents needed to prepare them.
- Representative operating modes and conditions of use.
- Accessories, cables and associated peripherals.
- Hardware and software versions.
- Assessment criteria and available supporting evidence.
Assessments during the development phase can help identify gaps before the final test campaign. Any necessary modification must be examined for its effects on conformity.
Plan your test campaigns ahead
Do you have a prototype or are you preparing a new version? Tell us about your equipment, its use and your schedule so we can scope the necessary assessments.
Contact us05
Compile your technical documentation
The documentation brings together the elements that demonstrate conformity. Its content depends on the applicable legislation and may include in particular:
- Product description, drawings and design information.
- Risk analysis and measures adopted.
- References of the standards and methods used.
- Calculations, assessments and test reports.
- Instructions and information for users.
Prepare these elements throughout development to ensure the traceability of choices and consistency between the product assessed and the product placed on the market.
06
Draw up the declaration and affix the marking
Once conformity has been demonstrated and the procedure completed, the manufacturer draws up the required declaration of conformity and affixes the CE marking in accordance with the rules specific to the product.
The manufacturer also checks the identification, traceability, instructions and safety information. The supporting evidence must correspond to the version placed on the market. Subsequent changes must be examined to determine their impact on conformity.
How the Emitech Group can support you
Our support
Depending on the stage of your project, our support can cover:
- Identifying regulatory requirements.
- Defining the assessment and test plan.
- Development assessments and compliance testing.
- Assistance with technical documentation.
- Involvement of Emitech Certification within the scope of its notification.
Call on our teams for a specific step or to organise several aspects of your process.
Prepare for our first discussion
A few details to help us scope your needs:
- Your role in the supply chain.
- The product description and intended use.
- The main technical characteristics.
- The stage of development.
- The documents and test reports available.
- The target market launch date.
Talk to our CE marking experts
Your questions about CE marking
You may be considered the manufacturer even if you do not carry out the manufacturing yourself. Placing a product on the market under your own name or trademark means you take on the corresponding obligations. The same applies if you modify a product already placed on the market in such a way that its conformity may be affected.
The budget depends on the product, the requirements, the tests and the supporting evidence available. Modifications and the possible involvement of a notified body can also affect the cost. A technical scoping phase allows us to draw up a tailored proposal.
The timeline depends on the maturity of the product, the documents available from your suppliers, the assessments and any rework.
Anticipating the requirements from the design stage makes it easier to organise the steps.
Its supporting evidence may contribute to the assessment, but does not replace the analysis of the final product. Integration, interfaces and conditions of use may change the results or introduce other requirements.
Not systematically. The answer depends on the legislation and the assessment procedure. A test laboratory and a notified body have distinct roles.
Tests are one part of the demonstration. You must also complete the applicable procedure, compile the documentation and meet the other obligations.
Penalties vary according to the national legislation of the Member States. They may combine administrative penalties (withdrawal of the product from the market, consignment of the goods in the company’s warehouse) and criminal penalties (fines and imprisonment).
Further information on CE marking is available on the European Commission’s official website: CE Marking.
You can also consult the European Commission’s Blue Guide
Why choose Emitech to make your products compliant?
- Complete expertise in EMC, electrical safety, radio frequency and mechanical testing.
- Accredited laboratories for reliable, standards-compliant testing.
- Notified Body (NB 0536) for rapid regulatory validation.
- End-to-end support: from design to market launch.
- Secure compliance and proactive regulatory monitoring.
- Possibility of integrating your regulatory procedures for your export markets.
Related Services
Needs
Discover a selection of additional resources that explore topics related to this page including regulatory contexts, technical articles, and specific areas of expertise. These materials provide further insight to help you better understand the key challenges and available solutions.
Prepare your project with our experts
Would you like to determine the procedures required for your product?
Tell us about your equipment, its intended use and your deadline. Our teams will help you clarify your needs.
