EU documentation standards and regulations
by George Lewis
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 withEU documentation 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.
So what happens if you do not follow the EU documentation 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:
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.
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.
George works as 3di’s Service Delivery Director. Passionate about helping each individual team member reach their full potential. Outside of work George can be found cycling, reading books on business and psychology, as well as taking the odd trip to Spain or Germany.