Step 4: Technical File
Introduction to Technical File
The Technical File Explained
In this lesson, you’ll be guided through the practical steps of compiling a Technical File. Using this methodology, it is ensured that all legally required aspects of product compliance are covered. At the same time it leads to concrete results. Step-by-step, the product compliance is evaluated and documented: truly ‘self-certification’.
Please watch the introductory video on the Technical File below:
To start the lesson, click the “Start”-button below.
All European CE marking directives oblige the manufacturer to draw up a Technical File (or in the directives you’ll also find the term ‘technical documentation’). The Technical File must contain all information that is necessary to demonstrate the conformity of the product to the applicable requirements. The Technical File must be available as soon as the product is placed on the European market, whatever its geographical origin is. Typically, the Technical File must be kept for at least ten years from the last date of manufacture of the product. Some directives expressly provide for any other duration (5 years in the Medical Devices Directive and Active Implantable Medical Devices Directive and 3 years in the Directive concerning energy efficiency in household refrigerators and freezers). This is the responsibility of the manufacturer, or his authorized representative established within the Community.
The exact contents of the Technical File are not specified, although most directives give examples of documentation to be included. And as a rule, the documentation should cover the design, manufacture, and operation of the product. The details included in the documentation depending on the nature of the product and on what is considered necessary, from the technical point of view, for demonstrating the conformity of the product to the essential requirements of the relevant directive and, if the harmonized standards have been applied, to these instead by indicating the essential requirements covered by the standards.
Language of the Technical File
Several CE marking directives require that the Technical File is written in the official language of the Member State where the procedures are to be carried out, OR in which the approved certification body (so-called ‘Notified Body’) is established, or in a language accepted by it. Virtually all certification bodies accept documentation in English. The reason is of course that in order for the approved certification bodies to be able to carry out the conformity assessment procedures in a proper way and for the market surveillance bodies to be able to control compliance, the documentation should always be in a language understood by them. In that regard, it is recommended to make the Technical File and its documentation in English or an accepted language, even if this has not been explicitly mentioned in the CE marking directives that apply to your products. TIP: If English is not the language in which your design documentation or procedures are written, we recommend you start using it as your primary communication language for all product documentation. It saves a lot of time and money when you’re making the Technical File.
Retention of the Technical File in Europe
Most CE marking directives require that a full copy of the Technical File is kept available for inspection within the territory of the European Union and that there is a single point of contact to discuss CE compliance. If your company is located outside Europe, you will have to find a person or company to retain the Technical File. You may choose to give the Technical File to one of the European distributors. However, most manufacturers do not prefer to give Technical File to their distributors, because it contains a lot of confidential design and manufacturing documentation that they do not want to disclose to the distributor. Also, they want to keep their flexibility and not lose the possibility to change distributors.
Alura Group’s headquarters in Europe can retain your company’s Technical Files. Please contact us for the details.
Compile the Technical File
There is not one single prescribed format for the Technical File. In this course, we use a model that has been accepted by the European authorities. The Technical File format we use consists of three parts:
- Part A helps to identify which products are covered by the Technical File. It also contains the names and contact details of the persons who in terms of CE marking responsibility have a relationship with the product.
- Part B contains all information that is required to determine product compliance, as well as the consistency of production.
- Part C may be used to store information that is confidential or which is not to be disclosed in Part A or Part B.
Each of the three parts has multiple sections. This methodology of storing the information in different parts and sections allows you to find information easily, and, when requested, to provide authorities or trade partners with exactly the information they require, without having to disclose the whole Technical File. * TF Part A (=Technical File Part A): Company and Product Identification * TF Part B (=Technical File Part B): Product Compliance and Production Consistence * TF Part C (=Technical File Part C): Confidential Information.