Creating compliant manuals for the EU
Are you selling your products on the European market? The following will instruct you in the proper way to create a compliant user manual specifically targeted to the European Union. Follow these instructions to avoid legal pitfalls. Ferry Vermeulen provides guidance to help you comply with European standards.
This article was published originally in Communicator (Summer 2017). Communicator is the authoritative, award winning, journal for UK technical communicators. It is home to high quality, objective, and peer-reviewed features – current, relevant, and in-depth.
How to use the COMPLIAN-CE-Method to achieve EU compliance
Using the method, which I have named the COMPLIAN-CE-Method, will give you the following benefits:
- You will get an idea of how product compliance and product safety in the EU is organised
- You will know how to find out which products are regulated in the EU.
- Within your organisation, you will be seen as an expert on the European product legislation.
- You will know which standards to use for creating user instructions.
- You can develop manuals that are compliant for the European market.
Let’s break it all down into actionable steps.
The four steps to using the COMPLIAN-CE-Method to draw up EU-compliant manuals
There are four steps that make up the COMPLIAN-CE-Method:
1. Determine the directives and the harmonised standards specific to the product.
2. Determine all requirements for creating instructions for product use as specified in the applicable, relevant product legislation.
3. Determine the appropriate harmonised standard to instruct users. The most common of these is: EN-IEC 82079-1.
4. Draw up the instructions (and other technical documentation) according to the requirements.
Step 1: Determine the directives and the harmonised standards specific to the product.
Within the EU, any manufacturer can make use of Europe-specific harmonised standards in order to comply with relevant safety and health specifications. This enables the manufacturer to attach CE marking. Often these specifications establish requirements and instructions.
To identify the applicable directives and harmonised standards:
1. Go to http://ec.europa.eu/growth/single- market/european-standards/harmonised- standards_en (if the URL does not exist any longer, Google ‘harmonised standards’ and try to find the site of the European Commission, starting with ‘ec.europe’.
2. Determine which product groups or characteristics apply to your product (for example, for a battery-powered toy this could be Toy Safety, Electronic compatibility, and RoHS). Write them down on a piece of paper or in any electronic format.
3. Click on each product group or characteristic that you have just written down. Find and download the corresponding directive, for example click: Toys safety > Directive 2009/48/EC > PDF sign in the EN column and PDF row, to begin the download of the English directive.
4. Go to http://ec.europa.eu/growth/single-market/european-standards/harmonised-standards_en
5. Again, click on each product group or characteristic that you have just written down.
6. Scroll down until you find the list of harmonised standards.
7. Identify which harmonised standards apply to your product. For example, Toy safety (https://ec.europa.eu/growth/single-market/ european-standards/harmonised-standards/ toys_en) lists standards and their relevance.
- EN 71-1:2014 Safety of toys – Part 1: Mechanical and physical properties
- EN 71-2:2011+A1:2014 Safety of toys – Part 2: Flammability
- EN 71-3:2013+A1:2014 Safety of toys – Part 3: Migration of certain elements
Sometimes, it may be that you won’t find any relevant directive for your product. In that case, you have a product that is not part of CE marking. Within the EU, any manufacturer can make use of Europe-specific harmonised standards in order to comply with relevant safety and health specifications. This will enable the manufacturer to attach CE marking. Again, often these specifications establish requirements and instructions.
It is important to note that not every product must comply with CE marking and, therefore, does not need the logo. The fact is that CE marking should only be applied to products specifically denoted by EU harmonisation legislation. EU legislation that requires the CE mark to be applied to covered products (also known as CE marking harmonisation legislation) covers product groupings such as machinery, telecommunications equipment, medical apparatus, and toys. Legislation has been developed for more than 20 types of product.
In the absence of a CE marking directive, the alternative is the General Product Safety Directive (GPSD) # 2011/95/EC. The goal of this directive is to ensure the highest possible product safety within the EU. GPSD applies to any consumer product that is not completely or partially denoted by EU legislation for a specific sector. This includes gymnastics equipment, lighters, outdoor furniture, items for child care, and floating leisure items.
This directive also serves to complement some sector legislation provisions that do not address specific issues, including those relating to the obligations of importers and the powers of various authorities. The GPSD’s goals are to provide health and safety to consumers, attempting to keep the EU market free of unsafe consumer products and to permit the smooth operation of the market.
Step 2: Determine all requirements for creating instructions for product use as specified in the applicable, relevant product legislation.
Now that you have an overview of both the mandatory directives and the (voluntary) harmonised standards, study them to find the specific requirements on the instructions for your product.
To identify the requirements from the directives:
1. Open all relevant directives.
2. Use ctrl + f and type instructions to find the requirements regarding the instructions.
As an example, the 2009/48/EC Toys Directive gives the requirement in Figure 1.
To identify the requirements from the harmonised standards:
1. Purchase the relevant standards.
2. Use ctrl + f and type instructions to find the requirements regarding the instructions.
Step 3: Determine the appropriate harmonised standard to instruct users. The most common of these is: EN-IEC 82079-1.
Besides the product’s group-specific requirements from the directives and standards, there are also horizontal standards. A horizontal standard does not apply to just one specific product group, but contains rules across sectors for almost all branches of the industry. The IEC 82079-1:2012 – Preparation of Instructions for Use is such a horizontal standard. This concept has a considerable impact on the contents of the standard.
To identify the requirements from the harmonised standard:
1. Purchase IEC 82079-1:2012 and fully read and understand the standard.
2. Determine which requirements are important for your specific product.
Step 4: Draw up the instructions (and other technical documentation) according to the requirements
At this point, you have all the information to make your user assistance EU-compliant.
To make your documentation EU compliant:
1. Analyse the following gathered information:
- The requirements from the directives
- The requirements from the harmonised standards
- The requirements from IEC 82079-1:2012.
2. Draw up or optimise your documentation, taking the requirements from the directives and harmonised standards into account.
It is imperative that any manufacturing firm, distributor, and importer confirms that the products they sell comply with all current and applicable safety legislation. Any manufacturer can be deemed liable for damage created by defective products. By making certain that your manufactured products comply with current safety specifications, producers will most likely avoid any liability claims for defects.
All of the specifics for the liability of defective products are spelt out in Directive 85/374/EEC pertaining to the EU. The purpose of this directive is to establish liability that does not blame producers. Regardless, any time a defective product results in injury to consumers, the producer can be held liable.
This legislation specifically applies to movable product types including agricultural products, consumer products, pharmaceuticals, and electricity.
The information and circumstances that determine whether a product may be defective includes:
- Sales literature and other marketing tools
- Written instructions and warnings that are included with the product
- Product uses that are reasonably expected
- When the producer marketed the product.
Simply put, the manufacturer will likely be held responsible whenever a product defect is obvious and there is no question that the defect was responsible for any damage subsequently caused.
Any business that either manufactures, distributes, or imports from another country is required to ensure that their products are generally safe. The CE marking logo on any product is a declaration by the product’s manufacturing firm that it complies with all existing and applicable legislation. In the EU, any manufacturer can make use of European harmonised standards to maintain compliance with the relevant health and safety specifications spelt out in CE marking directives. This enables the organisation to apply CE marking. Additionally, many CE marking directives layout specifications for user instructions.
The letters ‘CE’ appear on many products traded on the extended Single Market in the European Economic Area (EEA). They signify that products sold in the EEA have been assessed to meet high safety, health, and environmental protection requirements.
Source: http://ec.europa.eu/growth/single-market/ ce-marking (accessed April 2017)
General Product Safety Directive (GPSD)
The aim of GPSD 2001/95/EC is to ensure that only safe products are made available on the market. The GPSD applies in the absence of other EU legislation, or national standards. It also complements sector- specific legislation.
Liability of defective products
If a defective product causes any damage to consumers or their property, the producer has to provide compensation regardless of whether there is negligence or fault on their part (Directive 85/374/EEC, adopted 1985). Directive 1999/34/EC extended the scope of liability to agricultural and fishery products.
Source: http://ec.europa.eu/growth/single-market/ goods/free-movement-sectors/liability-defective- products_en (accessed April 2017)
RoHS, Also known as Lead-Free, stands for Restriction of Hazardous Substances. RoHS is also known as Directive 2002/95/EC.
Source: www.rohsguide.com (accessed April 2017)
Directive 85/374/EEC http://eur-lex.europa.eu/legal-content/EN/ TXT/?uri=CELEX:31985L0374 (accessed April 2017)
European Commission ‘Harmonised standards’ http://ec.europa.eu/growth/single- market/european-standards/harmonised-standards_en (accessed April 2017)
IEC 82079-1:2012 ‘Preparation of instructions for use – Structuring, content and presentation – Part 1:
General principles and detailed requirements’ https://webstore. iec.ch/publication/7511 (accessed April 2017)
Vermeulen F (2016) ‘Creating compliant manuals for the US‘ Communicator, Autumn 2016: 31-35
Ferry Vermeulen is director at Berlin based INSTRKTIV GmbH. INSTRKTIV helps brands to create compliant and user-friendly documentation. Also read his User Manual Template Case Study, about how to create compliant user manuals for the EU.