It is important to understand that only the authorities given power to enforce the directives have a right to see the technical file. It does not need to be published or given to customers. With the exception of the Medical Devices Directive , there is no clear requirement that the file should be kept on EU soil. However, for a manufacturer based outside of the EU, any approach made by the authorities will initially come to the authorised agent or the importer of the goods, so they must have access to the file to be able to fulfil their legal obligations. Access to technical information may also be a condition of contract laid down by some customers.
Different directives treat the creation of the file with different priorities.
The LVD strictly requires the manufacturer to have the file in place before the CE mark is applied, whereas the Machinery Directive says that the file does not have to be in constant existence and thereby provides for a period of grace in which it can be compiled. In practice, it makes sense to ensure the file is created early in the life of a product and is then kept up to date. However, a technical justification for a claim of compliance is useful even where the standards route is used. In both cases, the manufacturer can provide a written technical argument for why they believe that their product complies with the essential requirements of the directive. However, clearly this argument must be based on sound technical reasoning, and to ensure that the manufacturer is not simply using the TCF as an excuse for poor design or EMC performance, the file must be checked by a Competent Body to verify that the claim of compliance is reasonable and based on sound engineering judgement.