In the process of preparing for and verifying CE compliance for a product, there is a considerable amount of documentation that must be generated and maintained. Some of the documentation is product specific and some is CE program related. Let’s discuss the documents that are required for all CE marked products.
Product Documentation: Most of the CE Directives, as well as most of the harmonized standards required by CE Directives, specify the need for the following documents specific to the product being CE marked:
CE Program Documentation: The CE Mark Directives also require documentation that is general to compliance with the specific Directive. While each CE Mark Directive has a list of what is required, documentation commonly required by the Directives includes:
Document Translation: Instructions for Use, Installation Instructions, Application Guide, and the Declaration must all be translated into the language of the country of destination.
Document Retention: Some Directives state that all CE documentation must be retained for 10 years after the date of manufacture. Other Directives state that the documentation must be retained for 10 years after the date of last sale in the EU. For that reason, we recommend document retention for at least 10 years after the last sale in the EU. NOTE – electronic file formats and ability to access archived files created with software and computers that become outdated and replaced over time should be considered.
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