How to CE mark an electronic product in 5 steps

This practical step-by-step guide explains how to CE mark electronics. More specifically, the guide explains how to find applicable regulations and directives, identify harmonised standards, create labels and documentation, and manage lab testing.

Note that this guide is written from the perspective of a manufacturer, which also includes companies selling products under their brand. Further, this guide assumes that your product is not subject to notified body reviews.

Step 1: Find applicable regulations and directives

Electronic products are subject to various EU regulations and directives. In most cases, more than one such regulation or directive is applicable. Here are some of the factors that decide what you must comply with:

• Input/output voltage
• Wireless communication functionality
• Whether your product contains a battery

The scope in the table below can help you determine which regulations and directives apply to your product:

Regulation/Directive	Scope
RoHS Directive	Electrical and electronic equipment
EMC Directive	Electrical and electronic equipment
Low Voltage Directive	Electrical equipment within the following voltage rating: a. 50-1,000 V for AC b. 75-1,500 V for DC
Radio Equipment Directive	Radio equipment
Ecodesign Directive	Energy-related products
Ecodesign for Sustainable Products Regulation*	Electrical and electronic equipment
Batteries Regulation	Batteries
Cyber Resilience Act	Products with digital elements that are designed to be connected to a device or network

*Only relevant if your product is covered by a relevant delegated act.

The regulations and directives, in turn, decide the following:

• Harmonised standards
• Labelling requirements
• Testing requirements
• Documentation requirements

To avoid making this guide overly complicated, the remaining steps use the Low Voltage Directive as the basis.

Step 2: Find applicable harmonised standards

Once you have established which regulations and directives to comply with, you will need to identify relevant harmonised standards under each of these. Note that more than one harmonised standard can apply to an electronic product.

Here are a few examples of harmonised standards under the Low Voltage Directive:

EN ISO 11252 – Lasers and laser-related equipment – Laser device – Minimum requirements for documentation

EN 50106 – Safety of household and similar electrical appliances – Particular rules for routine tests referring to appliances under the scope of EN 60335-1

EN 60252-1 – AC motor capacitors – Part 1: General – Performance, testing and rating – Safety requirements – Guidance for installation and operation

EN 60309-1 – Plugs, socket-outlets and couplers for industrial purposes – Part 1: General requirements

EN IEC 60320-1 – Appliance couplers for household and similar general purposes – Part 1: General requirements

EN 60335-1 – Household and similar electrical appliances – Safety – Part 1: General requirements

EN 60519-1 – Safety in installations for electroheating and electromagnetic processing – Part 1: General requirements

EN 60598-2-1 – Luminaires – Part 2: Particular requirements – Section 1: Fixed general purpose luminaires

EN 60669-1 – Switches for household and similar fixed electrical installations – Part 1: General requirements

EN 60695-10-3 – Fire hazard testing – Part 10-3: Abnormal heat – Mould stress relief distortion test

Ensuring compliance with applicable standards requires that their principles are incorporated into your technical drawings, writing diagrams, bill of materials, firmware, and other files. It is essential to ensure that your electronic product is designed for compliance from the very beginning.

You should also consider procuring components that are already CE marked. Here are some examples:

1. RoHS compliant PCBs and components

2. LVD compliant AC adapters

3. Batteries compliant with the battery regulation

4. Bluetooth modules compliant with the Radio Equipment Directive

While combining CE marked components will not automatically make the final product compliant, it can help you reduce the risk of testing failure in step 4. It can also reduce the overall testing cost.

Step 3: Create label file

Next, we will create label files that must be affixed to the product and the packaging.

CE mark

The CE mark must be affixed to the product, packaging, or instructions.

Traceability information

The following information must also be affixed product, packaging, or instructions:

• Product name
• Model number, serial number or batch number
• Manufacturer name
• Manufacturer address

Instructions and characteristics

Electronics regulations and directives also require that instructions and product characteristics be printed on labels. This can, for example, include the current or voltage the product is designed for.

You may also need to include safety instructions and warnings, but bear in mind that these are not acceptable as substitutes for compliance with the requirements outlined in the applicable regulations and directives.

Other labelling requirements

Additional labelling requirements can be found in regulations and directives listed in the table above.

Step 4: Product testing

Product testing is required to verify compliance with applicable harmonised standards. Here are a few examples of companies providing electronics testing solutions for the EU market:

• Intertek
• Bureau Veritas
• TUV Rheinland
• SGS

You will need to submit product samples or prototypes that represent the final product. It is therefore important that submitted samples contain the same components as the final product.

Your electronic product will then undergo a testing procedure, which can take anywhere from 2 to 4 weeks. This results in a test report which in turn is included in your technical documentation and supports your Declaration of Conformity.

Step 5: Create documentation

The final step of the CE marking process for electronics is to create a set of documentation. The following is based on the requirements under the Low Voltage Directive.

Declaration of Conformity

A Declaration of Conformity is issued by the manufacturer and describes the product, applied regulations and directives, applied harmonised standards, and other information.

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1. Product model/product (product, type, batch or serial number):

2. Name and address of the manufacturer or his authorised representative:

3. This declaration of conformity is issued under the sole responsibility of the manufacturer.

4. Object of the declaration (identification of electrical equipment allowing traceability; it may include a colour image of sufficient clarity where necessary for the identification of the electrical equipment):

5. The object of the declaration described above is in conformity with the relevant Union harmonisation legislation:

6. References to the relevant harmonised standards used or references to the other technical specifications in relation to which conformity is declared:

7. Additional information:

Signed for and on behalf of:

(place and date of issue):

(name, function) (signature):

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The Declaration of Conformity, together with the test report, is often used by the authorities and marketplaces to determine if your product is compliant.

Note that the format of the Declaration of Conformity differs between regulations and directives applicable to electronics.

Technical Documentation

The technical documentation includes technical information about your product. This includes, for example, component lists and wiring diagrams.

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(a) a general description of the electrical equipment;

(b) conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.;

(c) descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the electrical equipment;

(d) a list of the harmonised standards applied in full or in part the references of which have been published in the Official Journal of the European Union or international or national standards referred to in Articles 13 and 14 and, where those harmonised standards or international or national standards have not been applied, descriptions of the solutions adopted to meet the safety objectives of this Directive, including a list of other relevant technical specifications applied. In the event of partly applied harmonised standards or international or national standards referred to in Articles 13 and 14, the technical documentation shall specify the parts which have been applied;

(e) results of design calculations made, examinations carried out, etc.; and

(f) test reports.

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Note that the exact technical documentation requirements differ between regulations and directives applicable to electronics. It is therefore important to take all applicable regulations and directives, and their respective technical documentation requirements, into account.

User Instructions

Electronic products must normally be accompanied by instructions and safety information that describe the following:

1. Installation

2. Usage

3. Precautions

4. How to replace batteries or other components

5. Maintenance

6. Disposal

7. Warnings