EU Technical Documentation Requirements for Electronic Products

Technical documentation is generally required for electronics covered by one or more EU regulations or directives mandating CE marking. In this guide, we use technical documentation requirements listed in the Low Voltage Directive as a case study demonstrating how to create technical documentation for electronic and electrical products sold in the European Union.

We also address common questions about technical documentation for electronic products in the FAQ section.

(a) a general description of the electrical equipment;

It must be immediately clear which product the technical documentation is valid for. The general description of the electrical product often includes the following information:

• Product name
• Model number/SKU
• Batch number format
• Serial number format
• General product description
• Functionality description

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

This part of the technical documentation includes information, screenshots, and references to other files concerning the hardware and software of the electronic product. This is information you or the manufacturer likely already possess in the form of a product specification.

Here are some more specific examples of information that can be included:

Enclosure files

• Technical drawings of enclosures
• 3D files
• Label files

Electronic components

• PCB schematics
• Circuit diagrams

Bill of materials

The bill of materials (BoM) normally consists of a list of components and the quantity of each component used to assemble a single unit.

• Molded parts
• PCBs
• Cables
• Charging ports
• AC adapters
• Batteries
• Mounting brackets or screws
• Antennas
• Other components
• Other subassemblies

Software

• Firmware index
• Firmware documentation

Packaging

• Packaging dielines
• Packaging artwork

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

It is necessary to complement the files listed above with descriptions explaining their purpose and use. It should be possible for a market surveillance authority or other outside party to understand what the files are for and how they are relevant to your product.

(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;

In this section, you must list all harmonised standards identified under the applicable directives and regulations for your products. Here are some examples of harmonised standards under the Low Voltage Directive:

EN 60335-2-2 – Household and similar electrical appliances – Safety – Part 2-2: Particular requirements for vacuum cleaners and water-suction cleaning appliances

EN 60335-2-28 – Household and similar electrical appliances – Safety – Part 2-28: Particular requirements for sewing machines

EN 50618 – Electric cables for photovoltaic systems

EN 50689 – Safety of laser products – Particular Requirements for Consumer Laser Products

EN 60598-2-8 – Luminaires – Part 2-8: Particular requirements – Handlamps

EN 61199 – Single-capped fluorescent lamps – Safety specifications

EN 50289-1-3 – Communication cables – Specifications for test methods – Part 1-3: Electrical test methods – Dielectric strength

EN 50556 – Road traffic signal systems

EN 60034-11 – Rotating electrical machines – Part 11: Thermal protection

EN 61010-1 – Safety requirements for electrical equipment for measurement, control, and laboratory use – Part 1: General requirements

Note that more than one EU directive or regulation can apply to electronic products. In these situations, you must list harmonised standards which demonstrate compliance with all applicable EU regulations and directives. Standard can also be applied in part, in which case it’s necessary to clarify which parts have been applied.

When applied, the following must also be listed under this section:

• EN standards, which are not harmonised
• European national standards
• IEC standards, ISO standards, or other international standards
• Other technical specifications

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

Verifying compliance with applicable harmonised standards requires that your electronic product undergo some sort of testing procedure. Regardless of whether this is done in-house or at a third-party testing laboratory, the methods used to verify compliance must be explained in detail.

This can include detailed descriptions of the following:

1. Lab tests carried out and their corresponding standards

2. Testing standards applied for each lab testing procedure

3. Compliance verified through estimates and calculations

The purpose of this section is to provide clarity on how you verified compliance with the applied standards, which in turn are meant to demonstrate compliance with the applicable EU regulations and directives.

It’s essential that you provide a clear description of the sequence your product went through to achieve this. Testing standards, test methods and calculations are normally written in the test report.

(f) test reports.

Test reports demonstrating that your product passed testing must be indexed and referenced in your technical documentation.

Test report index example

Test report title	Scope	Harmonised standards
INT0725-001-RoHS	RoHS Directive	EN IEC 63000:2018 – Technical documentation for the assessment of electrical and electronic products with respect to the restriction of hazardous substances
INT0725-002-LVD	Low Voltage Directive	EN 60204-1:2018 – Safety of machinery – Electrical equipment of machines – Part 1: General requirements EN 60204-32:2008 – Safety of machinery – Electrical equipment of machines – Part 32: Requirements for hoisting machines
INT0725-003-EMD	EMC Directive	EN 50370-1:2005 – Electromagnetic compatibility (EMC) – Product family standard for machine tools – Part 1: Emission EN 50370-2:2003 – Electromagnetic compatibility (EMC) – Product family standard for machine tools – Part 2: Immunity

Product information

It’s essential that the test reports included in your technical documentation can be linked to the relevant electronic product. As such, you should only include test reports that indicate the correct product model or SKU.

Including a product photo, which is standard practice, also makes it easier to link the test report to your product.

Other information

You can also specify the following information about the test reports:

• Test date
• Testing company
• Test facility
• Contact details

Component test reports

In some cases, you can also include test reports obtained from component suppliers. This can, for example, include the following:

• RoHS test reports for electronic components
• Battery test reports
• AC adapter test reports

While you normally cannot rely entirely on test reports for individual components, these can still help you reduce testing costs and minimise the risk of testing failure.

Other technical documentation requirements for electronics

This article uses the technical documentation requirements of the Low Voltage Directive as the basis. However, technical documentation requirements can also be found in the following EU regulations and directives for electronic and electrical products:

• RoHS Directive: Module A of Annex II to Decision No 768/2008/EC
• Low Voltage Directive: Annex III
• EMC Directive: Annex II, Annex III
• Radio Equipment Directive: Annex V
• Ecodesign Directive: Annex IV
• Ecodesign for Sustainable Products Regulation: Annex IV
• Cyber Resilience Act: Annex VII
• Batteries Regulation: Annex VIII

FAQ

Is technical documentation mandatory for electronic products?

Yes, electronic products covered by one or more CE marking directives (which is almost always the case) must come with a set of technical documentation.

Who is responsible for creating the technical documentation for electronics?

The manufacturer is generally responsible for creating the technical documentation.

Do we need to create technical documentation for each electronic product?

Manufacturers normally create one set of technical documentation for each individual electronic product model or SKU. It would not be practical to group multiple products together in a single set, as the files, standards, test procedures, and so on are different.

Do we need multiple sets of technical documentation if our electronic product is subject to many different EU regulations and directives?

The typical approach is to create a single set of technical documentation for each product model. However, as the technical documentation requirements differ depending on the applicable regulations and directives, it’s often necessary to include document items from all applicable requirements.

If, for example, your product is subject to both the Low Voltage Directive and the EMC Directive, then you will need to ensure that your technical documentation contains information and file items mandated by both directives.