March 31 2023

Are your user manuals legally compliant? Key information on EU instruction manual legislation

In our previous article on user manuals, we gave you an introduction to how these types of manuals are made, the main regulations relating to them, and the best way to get one done for your products.

However it is important to note that product user manuals in the European Union are subject to very strict regulations, which must be complied with in order to sell your product in EU countries. Therefore in this article, we will look into the EU regulations in finer detail, to ensure you have all bases covered.

While consumers often take user instructions for granted, many importers and manufacturers overlook the fact that user instructions are mandatory for a wide range of products in the European Union. Therefore, failing to create a sufficient user instruction manual could result in the issue of fines or a product recall.

Which products require user instructions in order to be sold in the European Union?

Many directives and regulations in the EU require importers and manufacturers to provide instructions for end users. This measure is to inform users of the intended purposes, proper usage, potential hazards, and other relevant information about the product.

Electronic products

Several directives require that electronic or electrical products must be provided with product usage instructions. This is to ensure that customers know how to use the products in a safe manner, how to avoid accidents such as electric shocks, and how to dispose of the products.

Here are some examples of electronics that must be sold with a user instruction manual:

AC adapters
LED lighting
Video players
Toasters
Handheld laser equipment

Many electronics products sold in the EU must comply with the below directives. All three of these directives require the product to be accompanied by user instructions:

Toys

The Toy Safety Directive requires that toys intended to be used by children under 14 years of age must be accompanied by a copy of the instruction manual which explains safety information, product usage guidance, potential hazards, and other necessary information in a language that is easily understood by the consumers.

The user instructions, if necessary, should also contain warning symbols and statements that indicate the hazards and accidents that may arise during the use of the toys, such as age warnings, choking warnings, adult supervision warnings, and allergy warnings.

Here are some examples of toys for which specific warnings are required:

Activity toys
Chemical toys
Roller skates, skateboards, toy bicycles
Aquatic toys
Percussion toys

Personal Protective Equipment (PPE)

The EU Personal Protective Equipment Regulation mandates that personal protective equipment placed in the EU market must include user instructions that contain detailed information for storage, use, cleaning, maintenance, servicing, and disinfection of the products.

Markings, symbols, or warning statements must also be included in the instructions, when this information is too big to fit into the product’s label.

Here are some examples of protective equipment that must include user instructions:

Safety goggles
Respirators
Safety helmets
Protective clothing for motorcycle riders

Construction Products

The Construction Product Regulation requires that construction products must be accompanied by instructions, including instructions for assembly and safety information.

Medical Devices

The Medical Devices Regulation requires that covered products include instructions for use, which should contain the device’s intended purpose, proper use, and precautions be taken when using the device.

Product examples include:

Surgical masks
Infrared thermometer
Electronic blood pressure test device
Handheld laser hair removers

Machinery

The Machinery Directive requires manufacturers of machinery to ensure that their products carry an instruction manual that includes at least the following information:

Manufacturer’s information
A general description of the machinery
Components and spare part description
Illustrations explaining the assembly, installation, use, maintenance, and repair of the machinery
The condition description of when the machine is normally functioning and malfunctioning
Misuse warnings

See “Annex I, part 1.7.4.2. Contents of the instructions” of the Directive to read more about the general principles of drafting the instructions and the instruction content overview for machinery.

General Product Safety Directive (GPSD)

All consumer products are subject to the General Product Safety Directive (GPSD), which places emphasis on the inclusion of “Instruction for assembly, installation, and maintenance” for ensuring product safety. Therefore, it is advisable for products covered by the GPSD to contain user manuals, safety instruction brochures, or similar information for consumers.

While the GPSD establishes general requirements, manufacturers and importers can refer to specific EU standards to obtain detailed information on how to create user instructions. For instance, for certain types of gym equipment like dumbbells, weight discs, rowing machines, or training benches, importers or manufacturers can refer to relevant sections of the EN 957 – Stationary Training Equipment, which outlines the requirements for general instructions, including assembly and maintenance instructions.

Are user instructions required for CE-marked products?

The majority of CE directives and regulations require that products within their scope must be accompanied by instructions and safety information, although some exceptions exist. For example, the RoHS Directive does not explicitly require instructions. Nevertheless, it’s worth noting that not all products may require the inclusion of an instruction manual or booklet.

Let’s take as an example a toy that doesn’t require installation, maintenance, or usage explanation, such as a small bouncy ball.

In this case, a manual might not be needed. However, according to the dimensions of the product, you might need to add a small part warning to the product or the product labeling, indicating that the toy should not be given to children younger than 3 years, as it presents a choking hazard.

Are user instructions required for other (non-CE) products?

The General Product Safety Directive (GPSD) requires that consumer products be safe for use, even if they are not explicitly covered by particular CE directives or regulations. It is the responsibility of either the manufacturer or the importer to determine the necessary instructions required to ensure user safety.

Here some examples of products that should include detailed user instructions, including installation, assembly, and manutention instructions:

Baby cribs
Rowing machines
Steppers

Now, let’s take as an example a t-shirt. In this case, a user manual is generally not needed, as it is reasonable to assume that everybody knows how to wear a t-shirt. Note that you might still need to include care instructions, at least on the labeling of the products.

Examples of instruction content

In this section, we are going to give some examples of what might be included in the user instructions, or user manual. Note that, in order to draft your user instructions, you can also refer to the following voluntary standard, which provides principles and requirements for products user instructions:

IEC/IEEE 82079-1 – Preparation of information for use (instructions for use) of products — Part 1: Principles and general requirements.

First of all, it is important to include a table of content, in order to make the information easily accessible to consumers.

Product and company information

The product information shows the identity and specification of the product, which usually contain the following details:

Product name
Model number
Serial number
Dimension
Color
Rated voltage/power (for electronics)

The importer or manufacturer’s information usually is displayed in the first few or end pages of the user instructions, and it might include the following:

Company name and/or trademark name
Postal address
Email address and/or company’s website
Contact person

Intended use

This section explains the intended purposes of the product. It must describe what and how the device is used for.

Let’s take baby carriers as an example. The description of the intended use of a baby carrier could specify these elements:

Different methods of using the products
Intended user group
Intended use environment

List of components and accessories

Product components, spare parts, and accessories description constitute an important part of the user instruction. Take a toaster, for example, the part description could be broken down to:

Toastrack
Rack control handle
Bread slot
Carriage handle
Control panel
Crumb tray

Usually, diagrams are added to help users quickly recognize and understand the parts and their functions.

Safety warnings and compliance marks

Warning statements and safety instructions are an essential part of the user instructions. As an example, specific toys might require specific safety warnings, including:

Toys containing small parts
Science experiment kits
Electric scooters
Aquatic toys

For electrical and electronic products, the safety instructions might include the description, warning, and instruction of these following aspects:

Electric shock hazards
Suitable power voltage/source
Suitable usage environment
Appropriate use age for children
Flammability hazards

Compliance marks, if applicable, such as CE Mark, separate collection symbol, and other marks should be indicated in the user instruction.

Assembly, installation & use instructions

The aim of this section is to provide instructions on the assembly, installation, and usage of a particular product, using a household fan as an illustration. The user manual for a fan must contain clear and comprehensible instructions for general users to follow while assembling, installing, and operating it.

The assembly and installation instructions for a fan should consist of a series of steps with accompanying illustrations that demonstrate the correct sequence for assembling the fan. The operational instructions should include an explanation of each button’s function, such as speed settings, oscillating settings, or other settings.

Maintenance and cleaning instructions

The purpose of this section is to present techniques for maintaining and cleaning the product to ensure its proper functioning and prolong its lifespan.

For instance, the maintenance instructions for a fan might advise users to unplug the device before cleaning and to avoid using abrasive cleaning agents such as metal polish on the product.

Disposal and recycling instructions

The symbol of a crossed-out wheeled bin, indicating separate collection, must be displayed on electronic products and batteries. Additionally, a statement should accompany the symbol, stating that these products should not be disposed of with regular household waste.

Other Information

Other information such as important notices and warranty information might also be included in the user instruction if necessary.

Language Requirements

User instructions should be composed in a language or languages that can be understood by the intended market’s consumers. For instance, if a cellphone is being imported to Luxembourg, the user instructions must be provided in both French and German. For this step, it is highly recommended to call upon the services of a translation agency specializing in user manual translation.

Source

How can we help you with the next steps?

HI-COM has a wealth of experience in handling multilingual translations of user manuals for a wide range of consumer goods manufacturers such as BMW, FRANKE, MIKRON TOOL, CASINO GROUP, and DECATHLON.

To find out how HI-COM can help with the translation of your product instruction manuals, get in touch with us today!