What should be in my technical file?
What is a Technical File?
The technical file: it may sound like a bundle of papers and documents, but it is the most important document when it comes to obtaining CE marking for your products. In this article, we take a closer look at what all must be in a technical file, according to various CE directives and regulations.
So what is it exactly?
The technical file is a collection of documents that detail how a product, device or machine was designed. More importantly, it serves as the final proof that the product meets all the requirements set forth in the relevant CE directives and regulations.
All CE marked products must be accompanied by an “adequate” technical file. This file contains specific information that varies based on applicable guidelines. For example, the technical file for a machine, officially known as the technical construction file, must meet the requirements of the Machinery Directive. Similarly, this applies to the technical file of toys, as stipulated in the Toys Directive. Exactly what is “adequate” is specified in the specific guideline.
What should be in the technical file for consumer electronics/items?
Each guideline may differ on exactly what should be in a file. In general, though, the following points are always required by EU law:
(a) a general description of the electrical equipment;
(b) design and manufacturing drawings as well as diagrams of components, parts, circuits, etc;
(c) adequate risk analysis and assessment.
(d) descriptions and explanations necessary for understanding those drawings and diagrams and the operation of the electrical equipment;
(e) a list of the harmonized standards applied in whole or in part
(f) the results of design calculations, investigations, etc., performed; and
(g) test reports.
(h) declaration of conformity
Compilation of the technical file is a crucial step in the CE marking process, namely step 5. This brings together all the information needed to demonstrate regulatory compliance. Should you need help with step 5, Instrux can provide excellent assistance with that. You can request assistance through our intuitive order page, or through our contact page.
Access to Technical File: Important for Market Supervision
When there are doubts about the safety of a product or compliance with directives, the technical file should be immediately available to market surveillance authorities. If the product is actually found to be unsafe or non-compliant, authorities may even demand that the product be removed from the market through a product recall.
Keeping the technical file is serious business. Generally, the manufacturer or importer must retain it for 10 years. Market regulators within the European Union can demand a copy of the technical dossier even many years after the product is launched. However, clients do not necessarily have to have access to this file; it is not required to be disclosed.