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.

CE marking, overview

Author Hugues Orgitello Last updated 25 May 2026

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?

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

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, its packaging and its documentation, respecting the mandated dimensions and proportions.

CE marking, overview

Who needs CE marking?

The six-step procedure

Further reading