• Product User Instructions Requirements in the European Union

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    Product User Instructions

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    User instructions are generally speaking documents explaining how to install, properly use, and dispose of products. User instructions can also include battery replacement instructions, warning texts, and more.

    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. Hence, failing to create a sufficient user instruction document can result in fines or a product recall.

    Keep reading, and learn the basics that importers, manufacturers, and Amazon sellers must know about creating user instructions for electronics, toys, and many other consumer products.

    Which products require user instructions in the European Union?

    Many directives and regulations in the EU require importers and manufacturers to provide instructions, sometimes also referred to as “instructions for use” or “user manual” to the end-users. This measure is to inform users of the intended purposes, proper usage, potential hazards, and other relevant information about the product.

    In this section, we provide examples of products that are required by specific directives or regulations to be accompanied by instructions.

    Electronics

    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, how to dispose of the products, and more.

    Here we list some example of electronics that should be sold with a user instruction manual:

    Here we list some directives that require the product to be accompanied by user instructions:


    Quote from Article 6.7 (Obligations of manufacturers) and 8.4 (Obligations of importers), Low Voltage Directive:

    “Manufacturers/importers shall ensure that the electrical equipment is accompanied by instructions and safety information in a language which can be easily understood by consumers and other end-users, as determined by the Member State concerned.”

    Source: Link


    Toy Safety Directive: 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

    Quote from Article 4.7 (Obligations of manufacturers) and 6.4 (Obligations of importers), Toy Safety Directive:

    “Manufacturers/importers shall ensure that the toy is accompanied by instructions and safety information in a language or languages easily understood by consumers, as determined by the Member State concerned.”

    Source: Link


    PPE Regulation: Personal Protective Equipment

    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.

    Point 1.4 of Annex II lists additional information that might be included in the instructions, such as:

    a. Class of protection for the different risks and limits of use, when applicable

    b. Date of obsolescence of the product and/or some of its components, when applicable

    c. Type of packaging and suitable for transportation, when applicable

    Also, markings, symbols, or warning statements must 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

    Quote from Article 8.7 (Obligations of manufacturers) and 10.4 (Obligations of importers), Personal Protective Regulation:

    “Manufacturer/importers shall ensure that the PPE is accompanied by the instructions and information set out in point 1.4 of Annex II in a language which can be easily understood by consumers and other end-users, as determined by the Member State concerned.”

    Source: Link


    CPR: Construction Products

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


    Quote from Articles 11.6 (Obligations of manufacturers) and 13.4 (Obligations of importers), Construction Product Regulation:

    “When making a construction product available on the market, manufacturers/importers shall ensure that the product is accompanied by instructions and safety information in a language determined by the Member State concerned which can be easily understood by users.”

    Source: Link


    Medical Devices Regulation: 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

    Quote from Article 23.1 (a), Medical Devices Regulation (Label and instructions for use):

    “The medium, format, content, legibility, and location of the label and instructions for use shall be appropriate to the particular device, its intended purpose and the technical knowledge, experience, education or training of the intended user(s). In particular, instructions for use shall be written in terms readily understood by the intended user and, where appropriate, supplemented with drawings and diagrams.”

    Source: Link


    Machinery Directive: Machinery

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

    a. Manufacturer’s information

    b. A general description of the machinery

    c. Components and spare part description

    d. Illustrations explaining the assembly, installation, use, maintenance, and repair of the machinery

    e. The condition description of when the machine is normally functioning and malfunctioning

    f. 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.


    Quote from Article 1.7.4 (Instructions), Machinery Directive:

    “All machinery must be accompanied by instructions in the official Community language or languages of the Member State in which it is placed on the market and/or put into service.”

    Source: Link


    General Product Safety Directive (GPSD)

    The General Product Safety Directive (GPSD) applies to all consumer products, and it mentions “Instruction for assembly, installation, and maintenance” as an important aspect of the safety of the product. This means that products that are covered by the GPSD should preferably contain a user manual, safety instruction brochure, or similar information to consumers.

    Even though the GPSD only establishes general requirements, importers and manufacturers can often refer to specific EN standards for detailed information on how to draft the user instructions.

    For example, if you are an importer or manufacturer of certain types of gym equipment, such as dumbbells, weight discs, rowing machines, or training benches, you can refer to relevant parts of the EN 957 – Stationary Training Equipment, which specifies the requirements for general instruction, such as assembly and maintenance instructions.

    Here we list some examples of products for which relevant EN standards include information about how to write user instructions:

    a. EN 13209-1 – Child use and care articles – Baby carriers – Safety requirements and test methods – Framed back carriers

    b. EN 14350 – Child Care Articles. Drinking Equipment

    c. EN 957 – Stationary Training Equipment


    Quote from Article 2 (i), General Product Safety Directive:

    “the characteristics of the product, including its composition, packaging, instructions for assembly and, where applicable, for installation and maintenance.”

    Source: Link


    Are user instructions required for CE-marked products?

    Most CE directives and regulations mandate that covered products should be accompanied by instructions and safety information (there are some exceptions, such as the RoHS Directive, which doesn’t mention instructions). Having said that, not all products might need to include an instruction manual or booklet.

    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 GPSD mandates that consumer products should be safe for the user, even if they are not covered by specific CE directives or regulations. It’s the responsibility of the manufacturer or the importer to determine what kind of instructions are needed to ensure the safety of the user.

    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.

    User instructions examples

    In this section, we provide examples of what might be included in the user instructions, or user manual. Note that, in order to draft the 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.

    Table of content

    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

    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

    This section is supposed to explain how to assemble, install and use a given product. Take a household fan as an example. The user instructions for a fan should include guidance for assembly, installation, and operation. Each procedure must be explained in legible and understandable language for the general users to read.

    The assembly and installation instructions of a fan might include steps, illustrations instructing users how to assemble the fan in the correct order. The operation instruction might include a function explanation for each button, such as speed settings, oscillating settings, or other settings.

    Maintenance and cleaning instructions

    This section is supposed to introduce methods for the proper maintenance and cleaning of the product in order to maintain the normal functioning and extend the service life of the product.

    For example, the maintenance instructions of a fan might tell the users to disconnect the appliance from the outlet before cleaning and to never use metal polish or other erosive cleaning agents on the product.

    Disposal and recycling instructions

    Electronic products and batteries must bear the separate collection symbol, which is an icon of a crossed-out wheeled bin. A statement should also be added to explain that the products should not be thrown away with 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 must be written in language or languages which could be understood by the consumers of the destined market. For example, if you are importing a cellphone to Luxembourg the user instructions must be written in French and German.

    Below we provide the language requirements from the Toy Safety Directive.


    Quote from Article 4.7 (Obligations of manufacturers) and 6.4 (Obligations of importers), Toy Safety Directive:

    “Manufacturers/importers shall ensure that the toy is accompanied by instructions and safety information in a language or languages easily understood by consumers, as determined by the Member State concerned.”

    Source: Link


    User Instruction Service Providers

    In this section, we introduce several companies that provide user manual creation, development, and modification services for product importers and manufacturers.

    Manualise

    Manualise is a company specializing in providing user guide services based in Delft, The Netherlands. The company helps clients from the consumer product industries to develop, improve and manage their user manuals, quick user guides, and installation manuals that are compliant with the requirements of EU directives and regulations, and other national regulations.

    Manualise’s team is composed of experts from disciplines, such as mechanical engineering, process engineering, electrical engineering, and industrial design with background and experience of illustration, which enable the company to deliver professional writings and technical, understandable illustrative works to the clients.

    Manualise creates user guide development services for electronic and electrical devices, household appliances, furniture, and chemical products.

    Manualise has served notable clients including AkzoNobel, Schneider Electric, Fischer, Ziggo, Skil, and Eneco.

    Service Categories

    • Quick start guide
    • Installation manual
    • User manual
    • Graphics design
    • European and other (inter)national regulations compliance check

    Company Information

    • Year of Registration: 2006
    • Locations: The Netherlands

    HQ Address: Rotterdamseweg 183 C, 2629 HD Delft, The Netherlands

    CE-CON

    CE-CON was founded in 2008 in Bremen, Germany, as a consulting agency and an online academy, helping enterprises in the field of CE compliance.

    CE-CON provides comprehensive consulting, developing, and improving services, covering external and internal documents issued to the market surveillance authorities or the customers, including instruction manuals, warnings, safety data sheets, schematics, technical drawings, and functional specification documents.

    In cases when the clients already have existing manuals but require documentation improvement, CE-CON can conduct a documentation check and examine the compliance of standards, the design, and structure of the texts, warning statements as well as working on language optimization and localization.

    Service Categories

    • Installation manuals
    • Warning statement
    • Safety data sheets
    • Schematics
    • Technical drawings creation
    • Quality assurance verification

    Company Information

    • Year of Registration: 2008
    • Locations: Germany, United States

    HQ Address: Lloydstraße 4 – 6, 28217 Bremen, Germany

    INSTRKTIV

    INSTRKTIV was founded in 2006 and specializes in offering solutions on legal compliant user instructions and user manuals for products manufactured in and imported into the EU.

    INSTRKTIV has a team of professionals with technical knowledge, legal expertise, and industrial design skills, providing user manuals development and improvement services against the EU regulations and directives.

    The core services provided by INSTRKTIV include mapping out legal requirements, language translation and localization, illustrations and graphic work design, generating online and a physical copy of the manual.

    At the same time, INSTRKTIV also provides add-value services such as providing user manual templates, software, and courses to help users create customized manuals.

    INSTRKTIV has extensive experience in the industry of electronics and medical devices, covering products including 3D printers, machinery, and electric cars.

    Service Categories

    • Installation manuals
    • User guides
    • Maintenance manuals
    • Work instructions
    • Packing instructions
    • Training manuals

    Company Information

    • Year of Registration: 2006
    • Locations: Germany, The Netherlands, United States

    HQ Address: Lohmühlenstraße 65, 12435 Berlin, Germany

    Impala Services

    Impala Services is a professional user manual creator and developer with locations in Hong Kong, Beijing, and Shenzhen. The company provides user manual compilation services in accordance with the national standards of the United States, Germany, Japan, and other European and Asian countries.

    Impala offers services for a wide range of products including household products, power tools, audio & video, ITE, and technical products.

    According to the information on Impala’s official website, 75% of their full-time technical writers own a Master’s Degree in Technical Communication, which guarantees the professionalism and high quality of the content.

    Service Categories

    • User manual
    • Assembly instructions
    • Quick start guide
    • 3D solutions
    • Packaging

    Company Information

    • Year of Registration: 2005
    • Locations: Hong Kong, Beijing, Shenzhen

    HQ Address: Unit E & F, 7/F, Selwyn Factory Building, 404 Kwun Tong Road, Kwun Tong, Hong Kong

    SGS

    SGS is one of the world’s largest and most influential testing and certification companies with its history dating back to the mid 19th century.

    Other than offering traditional testing and certification for consumer products and systems, the company also provides documentation assessment, verification, guidance, and improvement services, covering user manuals, technical files, declaration of conformity, safety data sheets, and functional specification documents.

    Service Categories

    • User manual and instruction card assessment
    • Technical files guidance
    • Identification of interpretation issues
    • EC declaration of conformity issuance guidance

    Company Information

    • Year of Registration: 1878
    • Locations: US, UK, EU, China, Korea, Japan

    HQ Address: 1 Place des Alpes, P.O. Box 2152, 1211 Geneva 1, Switzerland

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    Changes/Updates: Product standards and substance restrictions are subject to frequent updates and changes. In addition, new regulations, standards, and/or requirements may also become effective at any time. We don’t update our articles whenever new standards/regulations/rules are added or changed. We recommend that you consult a lab testing company or other professional to get the latest information about mandatory standards/regulations in your market, country, or state. Lab testing companies generally stay up to date on new and updated standards and regulations.

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