CE marking, overview
Pillar: European Union
The CE marking is the visible indicator that a product complies with the European directives that apply to it. Affixed by the manufacturer under its own responsibility, it is required to place the product on the market in the 27 EU member states as well as Norway, Iceland and Liechtenstein.
Who needs CE marking?
Section titled “Who needs CE marking?”CE marking applies to products covered by at least one "new approach" directive: electrical equipment, radio equipment, toys, medical devices, pressure equipment. For a connected electronic product, several directives typically apply at once:
- Directive 2014/30/EU, electromagnetic compatibility (EMC)
- Directive 2014/35/EU, low voltage electrical safety (above 50 V AC or 75 V DC)
- Directive 2014/53/EU, radio equipment (RED), for anything intentionally transmitting or receiving radio waves
- Directive 2011/65/EU, restriction of hazardous substances (RoHS)
- REACH Regulation, chemical substances
For radio equipment, the RED takes precedence: the safety and EMC requirements then apply through its Article 3.1(a) and (b), and the LVD and EMC directives do not apply separately (RED Article 1(4)).
The six-step procedure
Section titled “The six-step procedure”- Identify the applicable directives for the product. A miscall here undermines everything downstream, the RED directive in particular is often overlooked for products that integrate a commercial radio module.
- Select the corresponding harmonized standards, published in the Official Journal of the European Union. Applying them gives a presumption of conformity to essential requirements.
- Perform the required tests, in-house for equipped manufacturers, or in an accredited lab (COFRAC or any ILAC-equivalent) for tests subject to mutual recognition.
- Assemble the technical file, which must be retained for 10 years after the last unit produced and made available to market surveillance authorities.
- Draft and sign the EU Declaration of Conformity (DoC): the manufacturer's legal commitment.
- Affix the CE marking on the product or its data plate (also on the packaging for radio equipment), respecting the mandated dimensions and proportions.
Further reading
Section titled “Further reading”- Detailed scope: exclusions, custom-made products, second-hand equipment
- Step-by-step certification procedure: from standards selection to marking
- Most common pitfalls: non-recertified radio modules, missed RED directive, incomplete technical files
- Frequently asked questions: the questions that come up on every first CE project
- Comparison guide: CE vs FCC for EMC
See also
Section titled “See also”- Machinery Directive 2006/42/EC and Regulation (EU) 2023/1230: the largest sectoral directive in transition, frequently combined with CE.
- IEC 62133 and UN 38.3 for Li-ion battery safety and transport: battery requirements that complement the LVD chain.
- Cyber Resilience Act (CRA): the horizontal cybersecurity regulation that overlays the CE framework for digital products.
- Certification test plan, template and checklist: a reusable TPP structure for the CE test campaign.
- Choosing a Notified Body, NANDO and scope verification: the right way to pick an NB when one is required.
- UKCA vs CE, the difference between the two markings: what changes for Great Britain post-Brexit and when CE alone is enough.
Sources & references
- Regulation (EC) No 765/2008 , EUR-Lex eur-lex.europa.eu/eli/reg/2008/765/oj
- The European Commission's Blue Guide (2022) , European Commission eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52022XC0629(04)
Frequently asked questions
- Who is responsible for the CE marking?
- The manufacturer, or its EU-established authorized representative, bears responsibility for compliance and affixes the CE marking after assembling the technical file and signing the EU Declaration of Conformity.
- When is a Notified Body mandatory?
- When an applicable directive requires it, usually for higher-risk products (medical devices, ATEX) or when the manufacturer does not fully apply the harmonized standards.
- How long does CE marking take?
- From a few weeks (simple product, harmonized standards fully applied) to several months (external lab testing, product modifications, Notified Body involvement).
- Is CE marking a certification?
- No, in most cases it is a self-declaration of conformity. No third party "issues" the CE marking; the manufacturer affixes it under its own responsibility.
- Is CE marking valid outside the EU?
- It is mandatory in the EEA (European Economic Area) and recognized in Turkey. Switzerland has its own aligned system. Outside these areas, other certifications (FCC, PTCRB, etc.) apply.