Documentation and information

Working with CE marking produces a range of documents relating to the product, which can be stored in a binder or digitally. This so-called technical documentation does not always need to be permanently available and the period for which this file must be kept may vary for different products. This file must be available for consultation by an inspector where there is any doubt about the correct implementation of the CE marking.

The technical documentation contains the results of the risk analysis and the implementation of standards, the instruction manual, the implementation of the directives and regulations etc. and is intended to provide evidence that the requirements for CE marking have been met. It can be seen as a sort of insurance policy as it is very rarely used for this purpose. However, it is beneficial in other ways, in that it is a structured way of storing design information. Thus, in addition to the legal obligation to keep such a file, there are economic and commercial advantages. The technical documentation is usually kept by the manufacturer, but in some cases, it must be presented for inspection with a notified body.

In addition to the documentation for internal use, the product must be accompanied by certain other documents for the user. Firstly, the authorities must be able to see that the product may be traded freely within the borders of the European Economic Area EEA. This is demonstrated by the type plate bearing the CE marking, the EU declaration of conformity and possibly also in the separate instruction manual. Secondly, the new owner of the product must be given information on the possible applications, how it is operated, maintenance etc.

In a few cases no CE marking shows on the product, such as for s custom-made medical device intended for a particular patient, or for partly completed machinery to be incorporated into or assembled with other machinery. In those cases, other explanatory documents are also included.