The directives issued by the EU regarding the LVD require the manufacturer to prepare a technical dossier that demonstrates that the product meets the requirements of the directive.
The technical dossier contains the procedures necessary to prove this conformity if the manufacturer has produced in accordance with the quality of the product and technically harmonized standards, if the producer has not produced or partially complied with the harmonized standards but has complied with the requirements specified in the directive. In other words, it consists of putting together all kinds of documents that will justify the carrying of the product CE mark.
Although the term technical file is included under this name in every directive, a document with the same content in nature is absolutely required with different names. For example, Toys are named as Technical File, Non-Automatic Weighing Design Document, Simple Pressure Vessels Design and Production File names are used. These are files that are different in name but have the same expectations as content.
The Technical File consists of two parts. The first part consists of technical data on conformity assessment procedures.
The first part of the Technical Dossier includes;
- Name, address and identification of the manufacturer,
- List of harmonized standards applied by the manufacturer and the actions taken to meet the basic requirements,
- Product introduction,
- Instructions for use of the product (if any),
- Detailed plan of the product (if applicable)
- The second part of the Technical Dossier includes;
- Test reports,
- Plans of products and their functions,
- Standards applied,
- Other information is available.
An organization wishing to make CE marking for a product or products should first prepare a technical file for this product. The technical dossier forms the basis of the CE studies. Whether the company produces equipment that does not fall into the risky class and therefore uses its CE marking authority (at this point, it can receive consultancy service), whether it produces risky products and therefore needs to be tested by an authorized institution, a technical file is prepared
The Technical File should be made available to the authorities for control purposes. This obligation may be fulfilled by the manufacturer or his authorized representative within the EU if the producer is outside the EU. If the manufacturer is outside the EU and does not have a representative, the person placing the product on the EU market assumes this obligation.
The manufacturer or other responsible person gives the control authorities the first part, which is the explanatory part of the technical data. The entire file is required in cases where a multi-directional control is to be performed.
When creating a technical dossier that a machine manufacturing company should prepare, it should prepare the following information:
- Basic information about the manufacturer
- Label or plate on which the technical data of the product is obtained
- Intended use of the product
- Test Reports if available.
- List of national and international standards used in production
- Supply list,
- Certificates and test reports if products are covered by CE
- CE Declaration of Conformity.
- Detailed description of product installation, adjustment, operation, maintenance and transport activities
- The manufacturers, code numbers, specifications and certificates of all electrical / hydraulic / pneumatic components of the product, if any, have been previously tested and approved by a competent authority.
- Wiring diagrams of all electrical / hydraulic / pneumatic systems of the product
- Current operating instructions of the product
In addition, if the product is equipped with electrical equipment, some electrical tests such as LVD, EMC are required. The company must meet the necessary test equipment for this. Information about this equipment can be obtained by contacting our company. The complete preparation of this information will facilitate the preparation of the technical dossier and shorten the certification period.