The technical file is subdivided into two parts: part A and part B. The manufacturer must be able to demonstrate where and how each part of the technical file is held and maintained. The technical file may be stored as separate decentralised documents or together in a single location.
Part A consists of all documents related to the general design, manufacturing and testing of the product. It is usually given to the market surveillance authorities who use it to verify the CE marking's use for production series. This part contains information on compliance with regulations, standards etc. Part A of the technical file may also include or refer to appropriate certifications, declarations, quality system procedures, reports etc.
Part B consists of the documentation concerning the full design calculations, risk analysis, complete test reports, and individually CE-marked pieces of equipment. This part of the technical file is essential for verifying the CE marking symbol on a specific piece of equipment.
If the manufacturer does not follow the recommended two-part structure of the technical file and unless the details given in the EU declaration of conformity appear sufficient, the market authorities could request to see the complete technical file.