Development of technical documentation

According to the Technical Regulations, the technical documentation is documentation regarding a medical device that includes:

• a general description of the medical device, including any planned modifications of the device, as well as its intended use;
• design drawings, information on the intended manufacturing methods of the medical device, as well as diagrams of components, assemblies, circuits, etc.;
• descriptions and explanations necessary to understand the drawings, diagrams, and operation of the medical device;
• risk analysis results, information about standards fully or partially applied from the list of standards that correspond to European harmonized standards, and voluntary application of which may be seen as evidence of conformity of medical devices with the requirements of the Technical Regulation on medical devices, as well as a description of decisions made to meet the requirements of the Technical Regulation on medical devices in case of partial application of the mentioned standards;
• if the medical devices are marketed in a sterile state – a description of the methods used, as well as a validation report;
• results of design calculations and verifications.
• If the medical device is intended to be connected to other medical devices for its intended use, confirmation of its compliance with the requirements of the Technical Regulation on medical devices when connected to other medical devices;
• results of preclinical evaluation;
• results of clinical evaluation according to Appendix 10 to the Technical Regulation on medical devices;
• labeling and instructions for use.