A significant stage of the CE marking process is to produce technical documentation for the product to provide evidence of conformity for the relevant legislation. ‘Technical documentation’, ‘Technical Construction File’, ‘TCF’ and ‘Technical File’ are all references to the same documentation, but regardless to its official title, it is required in one form or another by all of the CE marking legislation to perform the same task.The specific contents of the Technical File is as under :
- A general description of the product,
- An overall drawing of the product, as well as other drawings to cover specific aspects of the product, such as circuits diagrams. Drawings shall, where appropriate, be accompanied with descriptions and explanations to understand the product.
- Full detailed drawings, with any calculations, test results, etc., providing proof of the products conformity with the essential health and safety requirements of the applicable Directive/Regulation,
- Copy of the risk assessment, which has documented the identification and mitigation of applicable risks and hazards
- A list of standards and other technical documentation that have been applied as part of the conformity process.
- Copies of conformity documentation for critical components of the product
- Copies of technical reports detailing any assessments carried out.
- A copy of instructions and other information supplied for the safe use of the product.
- A copy of the manufacturer’s Declaration.
Obviously the above list is not exhaustive of what can be kept in the technical file, other relevant information may also be added.