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Why Are There Legal Requirements
Certain products, such as machinery and electrical equipment, involve inherent risks. To protect users and ensure safe use, authorities impose legal requirements on these products. These requirements often extend to the accompanying user manual.
A clear and well-structured user manual enables users to install, operate and maintain a product safely and correctly. Legal requirements primarily focus on safety and clarity. They also relate to product liability and consumer protection. For example, manufacturers are typically required to include their name and contact details in the user manual.
Regulations, Directives, and (Harmonised) Standards
Within the European Economic Area (EEA)—which includes the EU Member States, Norway, Iceland and Liechtenstein—product safety and compliance are governed by three main types of legal instruments:
- Regulations
- Directives
- (Harmonised) standards
The table below explains these forms of legislation and provides an example for the product category “Toys”.
| Legislation form | Description | Example (Toys): |
| Regulation | A regulation applies directly in all EU Member States. It does not require national implementation. Regulations establish detailed and uniform rules that must be followed immediately. | Regulation (EC) No 765/2008 sets requirements for market surveillance and product conformity, including toys. It ensures that products placed on the EU market meet safety requirements. |
| Directive | A directive defines general objectives. Member States must implement these objectives in their national legislation. The method of implementation may differ per country. | Directive 2009/48/EC (Toy Safety Directive) sets safety requirements for toys sold in the EU, including chemical safety, physical safety and labelling. |
| (Harmonised) Standard | Standards provide technical specifications that help manufacturers comply with legislation. Compliance with harmonised standards generally creates a presumption of conformity with applicable directives and simplifies CE marking. | EN 71 is a harmonised standard for toy safety. It specifies mechanical and chemical safety requirements. |
By understanding the relationship between regulations, directives and standards, you can determine which requirements apply to your product and its user manual.
Harmonised Standards: A Practical Advantage
Compliance with a standard is generally voluntary. Standards provide technical guidance and support clarity, safety and quality.
Following a harmonised standard offers an important advantage: presumption of conformity. This means that compliance with the standard is accepted as evidence that your product meets the essential requirements of the applicable directive. As a result, conformity assessment and CE marking become more straightforward.
Which Regulations, Directives and Standards Are Relevant
The applicable legislation depends on the type of product and the market in which it is sold.
Examples of product-specific directives within the EEA include:
- Machinery Directive (2006/42/EC)
- Low Voltage Directive (2014/35/EU)
- Radio Equipment Directive (2014/53/EU)
- Toy Safety Directive (2009/48/EC)
Legal requirements for a user manual typically focus on safety and clarity. Common requirements include:
- Language Requirements
The user manual must be available in the official language or languages of the country where the product is placed on the market. - Safety Information
The user manual must include warnings where risks of injury or damage exist. - Intended and Foreseeable Use
The manual must state the intended use of the product and warn against reasonably foreseeable misuse. - Identification of Product and Manufacturer
The manual must include the name and address of the manufacturer or authorised representative. This enables users to contact the responsible party in case of questions or problems.
In addition to legislation, specific standards provide guidance on preparing user manuals. Examples include:
- IEC/IEEE 82079-1:2019 — Preparation of information for use (instructions for use)
- NEN 5509:2017 — User manuals
- ISO 20607:2019 — Safety of machinery – Instruction handbook – General drafting principles
General Legislation within the EEA
In addition to product-specific directives, general legislation applies to all products placed on the market within the EEA. Two important examples are Regulation (EU) 2023/988 and Directive 2024/2853.
Regulation (EU) 2023/988, which replaces Directive 2001/95/EC on general product safety, focuses on prevention. It requires manufacturers and distributors to place only safe products on the market.
Directive 85/374/EEC on product liability, and its successor Directive 2024/2853, address liability after damage or injury has occurred. They define when a manufacturer can be held responsible for harm caused by a defective product.
A product may be considered defective if the user manual contains significant shortcomings. Inadequate warnings or unclear instructions may therefore lead to liability. If you are unsure whether your documentation meets legal requirements, consider having a compliance check carried out by a specialist.
International Legislation
When exporting products, the legislation of the destination country applies.
In the United States, product regulations fall under various federal authorities. Depending on the product type, one or more agencies may be involved:
- OSHA (Occupational Safety and Health Administration) regulates workplace equipment, such as tools and machinery.
- CPSC (Consumer Product Safety Commission) oversees consumer product safety and sets safety standards.
In the United States, products often include more extensive warnings than in Europe. Court rulings have confirmed that manufacturers may be held liable if they fail to provide adequate warnings about potential risks. This legal environment encourages manufacturers to include clear and comprehensive warning labels. A well-known example is the warning “Caution: contents hot!” on beverage cups. Following a 1994 lawsuit involving severe burns caused by spilled coffee, the court ruled that the warning provided by McDonalds at the time was insufficient.
Understanding these differences helps you adapt your user manual to the legal expectations of each market.
Have Your User Manual Checked by Manualise
Are you unsure whether your documentation meets all applicable legal requirement for a user manual? Have it reviewed by Manualise.
Our legal compliance check includes the following steps:
- Review of your (draft) Declaration of Conformity
- Identification of the applicable conformity requirements for your user manual
- Preparation of a practical checklist with relevant legal requirements
- Detailed review of your user manual
- Delivery of a clear advisory report with findings and recommendations
This structured approach provides insight into potential risks and areas for improvement.
Would you like support in implementing the recommendations? Manualise will be pleased to assist you in updating and optimising your user manual.