Creating a technical file
The provisions regarding the CE mark compliance’s documentation are a part of the New Approach directives. Accordingly, the manufacturer of record has the responsibility to develop a technical file, also called a technical construction file. The technical file documents all steps a product has taken to comply with the CE requirements. The manufacturer of record usually is the person who places a product on the market. He is further in charge of identifying the specific CE directives, requirements and conformity assessment procedures.
The content of a technical file
The technical file shall consist of all documents spelt out in the list of essential requirements of the specific CE directives. In general, the technical file includes:
- A general description of your product;
- Information about your product’s design (e.g. circuit diagrams, design drawings, mechanical drawings, component list, manufacturing documentation, etc.);
- Description and explanations necessary to understand the above-mentioned drawings;
- Installation description and user manual for the product. The installation description must clarify how users should install and use your product;
- A list of the applicable CE directives and essential requirements;
- An analysis of the steps taken to ensure the safety of your product, including a list of the standards used either wholly or partially, or own standards/methods used to verify compliance with the respective CE directive; the results of any product resting; and, a product safety analysis. The safety analysis is mandatory for compliance of a product with the Machinery Directive, for example. By performing a safety analysis, the manufacturer of record assesses the risks’ probability and severity posed by the product in some areas and consequently documents the measures taken for reducing the specific risks. The most residual risks must be limited by the usage of interlocks, while the minor residual risks can be acknowledged with warnings.
- Certificates of CE compliance of the product from any required notified body.
- Other grounds used or that may be of use (such as calculations, simulations, etc.);
- Test reports.
Versions of a technical file
The preparation of the technical file is in two versions, conventionally named Part A and Part B. Part A contains all documents regarding the general design, manufacturing and testing of the product. Part A of the technical file is usually given to the surveillance authorities. Their interest is in verifying the CE mark’s use for production series. Part B consists of the documentation concerning the full design calculations, complete reports, and individually CE marked pieces of equipment. The latter version is essential in cases of verifying the CE mark on a specific piece of equipment.
When creating a technical file, you should consider the official language of the country where you want to sell it. According to the CE directives and the European national laws, you should always have the user information translated into the respective official national language. The translation of the rest of the technical file could be in any other European language. Moreover, the technical documentation’s location can be even outside Europe if the product’s manufacturing is not within the European borders. That is possible as long as the manufacturer on record has appointed an “authorised representative” who can ensure its provision if requested by the European authorities. If the surveillance authorities have requested the technical file, the same generally should be provided within one working week. The authorised representative is mandatory for products falling under the scope of the Medical Device Directive, and optional for all other directives.
The manufacturer of record only needs to have one authorised representative in the EU zone. He will be contacted if an issue of CE mark conformity arises. The specific location of the authorised representative is not of importance as long as it’s within the EU. For instance, if the authorised representative lives in Stockholm and someone in Berlin questions the CE compliance of a product, then the query will be forwarded to the Swedish authorities, who will contact the representative party. However, in case the particular product injures someone or seems to pose a safety threat, the German authorities have the right to take unilateral actions.
If the manufacturer doesn’t have any authorised representative on the European territory, then the surveillance authorities can request the product’s technical file from the importer, distributor or customers. If the person approached cannot ensure the provision of the documentation, the product in question can be pulled off the market and out of service.
The technical file should prove your product’s compliance with the CE directive/s. As a manufacturer, you should store it within the EU for about 10 years. If requested by authorities, you should be able to provide the technical documentation and a copy of your product’s CE Declaration of Conformity within a short time frame.