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:
- Instruction Manual: Everything the user needs to know to safely operate the product including Instructions for Use, Definition & Location of Controls, User Maintenance, Operating & Environmental Ratings, Residual Risk requiring user action (PPE, facility, etc.), Product Connections (electrical, air, other products, etc.), and any material hazard details. Harmonized standards have requirements that specify what must be included.
- Installation Instructions: Detailed installation instructions that include safe movement and assembly of the product as well as specifications concerning mounting means = surface material, hardware. Additional consideration for IP rated equipment defining the level of protection required from the environment (dust & water ingress).
- Application Guide: Predominantly for products such as construction products where details on acceptable applications including suitable construction methods and tools are important to insure product compliance.
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:
- Declaration: When the CE Mark is applied to a product, a written “declaration” must be included which specifies what basis for which you have applied the CE mark = this includes a Declaration of Conformity (DoC) required by most CE Mark Directives, a Declaration of Performance (DoP) as required by the CE Construction Products Regulation, or a Declaration of Incorporation (DoI) for products that fall under the CE Machinery Directive but do not bear the CE mark due to being on a piece of an overall machine.
- Technical Construction File: Each CE Mark Directive requires that the manufacturer maintain Technical Documentation related to verifying and maintaining compliance of the product with the CE requirements. The technical documentation is to be retained in a “Technical Construction File” (TCF). Each CE Mark Directive includes a list of the technical documents that must be maintained in the TCF. The Directives state that the TCF is to be created before preparation of the Declaration.
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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