Technical File for CE marking – What is it and how to make one?
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 provides 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.
How to build a Technical File? What should be the content and format?
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 depend on the nature of the product and on what is considered as 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.
There are no requirements regarding the structure and format of the Technical File. Nowadays the files may be kept in electronic format. Please note that the documents in the Technical File must be kept up to date. So whenever there are modifications to the product, or when there are amendments in the regulations, the content of the Technical File should be updated.
The rules for the exact content differ from one CE directive or regulation to another. Contact us for support in building and maintaining your Technical Files.
What are the language requirements?
Several CE marking directives require that the Technical File is written in an 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 to 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.
Who should keep the Technical File?
Most CE marking directives require that a full copy of the Technical File is kept available for inspection in the territory of the European Union. 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 manufactures do not prefer to give Technical File in the hand of its 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.
If you do not have offices in the European Union, and you do not want to put your files in the hands of distributors, we can help. We offer professional Technical File retention services. We will keep the Technical File in our European Headquarters, and will represent your company as your single point of contact for regulatory and compliance inquiries. This provides you with the peace of mind that inquiries are handled professionally and with your best interests in mind. Contact us for the details and for a draft proposal.