European Union (EU) product compliance is recognised by CE (Conformité Européenne) marking. This marking of products is based on compliance with the European Harmonized Standards and is used to show that products comply with the relevant health and safety requirements.

Many of the CE marking directives impact the requirements for user’s instructions. So how do you make your product documentation compliant with EU regulations?

CE marking and the General Product Safety Directive 2011/95/EC (GPSD) provide advice and guidelines for the manufacture and selling of consumer and professional products. However, the IEC 82079-1 Preparation Of Instructions For Use standard specifically covers product documentation.

To ensure compliance with EU documentation standards, here are some of the key points covered by this standard.

Clear and concise documentation

  • Consistent terminology: Throughout your documentation you should be consistent in the use of terminology. For example, product names, parts naming, description of procedures.
  • Short and concise stepped procedures: Procedures should be clearly numbered and long procedures should be avoided. Typically a procedure should be between 5-7 steps and each step should contain only one instruction or action.
  • Short paragraphs: Paragraphs should be short and only contain one or two points. For example, from the IEC 82709-1 standard:
    “The text of instructions for use shall be written in simple, clear, direct phrases within short sentences, thus following the principle One expression, one simple meaning. The logical structure of the text shall be clear.”
  • Text with illustrations: Illustrations should accompany the text that explains the context and content of the illustration. This eliminates the possibility of misunderstanding the text or illustration.
  • Illustrations easy to understand: Illustrations should limit the amount of information being shown. Too much information, for example, multiple callouts or long text labels could be confusing.

Structured content

  • Easy to find content: With good document structure you should be able to find the information you need with minimal effort. For example, using a well-designed table of contents or clear and visual chapter breaks.
  • Use a style guide: Using a style guide ensures consistency within a document and across a range of documents. Consistency helps the reader to identify important content because they know what to look for, for example, bold user interface labels or titles.
  • Page numbers and other numbered content: Numbering of pages, chapters, and sections helps a reader to navigate a document. A quick scan of a page should provide a clear indication of where the reader is in the document. This can also be helped using footers and page headings.
  • Table of contents: A table of contents helps the reader find content. It also helps provide a high-level overview of the content. For example, using a table of contents, a reader can quickly see the name of chapters and identify the chapter they think can best help them.

Document control and versioning

  • Document versioning: A document should include the document version. It should also include a date of production. This helps a reader identify documentation and its relevance to the product they are trying to use.
  • Contact details for manufacturer: As part of liability requirements (see below) it is recommended that contact details are provided for the primary manufacturer or supplier. This can include an address, telephone numbers, email, and a company or support website.
  • Part numbers: It should be easy for a reader to identify a product or parts of a product. This is particularly important for products that need to be maintained and used by skilled operators. Providing this information using tables and illustrations helps identify parts and related part numbers.

Clear product identification

  • Product versions: It should be easy for the reader to match the documentation with the product they are using. This can be done using part numbers, illustrations, or photos. If the documentation covers a range of products this should also be made clear to the reader.
  • Product specifications: Documentation should provide basic product information, for example, weight or size.
    For professional and regulated products the specifications may need to be more detailed and include regulatory compliance information.

Warnings and safety information

  • Warnings and cautions must be easy to find: It should be easy for a reader to identify a warning or caution or notice. A warning or caution includes a graphical element to highlight the information. Warnings, cautions and notices and their use is covered by – ISO 3864, for example:safety warning examples
  • Proper use of product: Apart from warnings, cautions and notices, the document should clearly explain the proper use of a product.
  • Consequences of improper use: It is not possible to cover all potential uses of a product. However it should be made clear to the reader the consequences of not using a product correctly. This could be anything from loss of warranty to serious harm for the user. This is usually covered in the second part of a warning notice.
  • Warnings before procedures: It is recommended that you put warnings before the start of a procedure. This ensures that the reader is fully aware of potential issues before they start using the product.
  • Repeating warnings: For some products, warnings and cautions must be included on the surface of the product itself. These warnings should also be repeated in the documentation in case the warning on the product is damaged or obscured.
  • Always read warnings: To limit liability you should include a reminder for the reader to read and understand all warnings before using the product.
  • Warnings always look the same: Throughout the documentation you should style warnings to look and present information in the same way. This helps a reader to quickly pick out a warning. For example, the graphical symbol for a warning should be positioned in the side margin with clear white space around it.
  • Handling procedures: For regulated products it may be necessary to include any specific handling procedures to ensure the product is not damaged and does not cause harm.

Legibility

  • Text easy to read: Text in printed or online documentation should be large and clear enough to be read. As the standard states:
    “Text fonts and graphical symbols used for information integrated in the product, of printed material and of computerized information shall be as clear and as large as practicable to ensure the best possible legibility for all users, including older users and users with visual impairment.”
  • Captions for table and illustrations: Captions should be included with illustrations and tables to help identify the content, again, helping with navigation and comprehension.
  • Tables: It is recommended that you use tables when providing lists of items, particularly items with matching content. Tables present content that is easier to visually search through, for example, by scanning down one column and then reviewing that item.
  • Bullets: Using bullets is another way to present lists that make it easier to find information.
  • Use white space: Use white space, for example, margins or paragraph spacing, to provide clear boundaries between content. Using white space prevents the reader from being distracted by other content that may not be relevant.

Product liability

So what happens if you do not follow the EU directives and standards?

Your products (manufactured or imported) must be safe and comply with the applicable legislation. You can be held responsible for damage or harm caused by your products. By ensuring that your products comply with the relevant safety requirements, you can minimise product liability claims.

Directive 85/374/EEC relates to liability. When a defective product causes harm to a user, you may be liable. Liability is assessed using the following principles:

  • The way the product was sold, for example, sales literature.
  • Any instructions or warnings that are given with the product. Either on the product or within any supporting documentation.
  • Adequate description of the product in the product documentation.

Additional requirements to the EU documentation standards

Although EU directives require adequate instructions for use, regulated products may require additional detailed or specific instructions and content. This specific content is defined as part of the product-specific regulations.

As the EU is made up from many countries, you may also have to take into account country-specific legislation that could impact your documentation. If you are producing non-consumer products that must comply with specific regulations and legislation, this is particularly important.

Conclusion

If you follow the directives, complying with EU documentation standards is straight forward. EU directives and regulations are generated and managed from a single authority so it is easier to write documentation that is compliant.

Does your current product documentation comply with the EU product documentation standards? Use 3di’s Documentation Audit Tool to help you do your own health-check on your documentation and documentation processes. To download the Tool fill the contact form and we will send it to you.