Technical documentation for a medical device

Technical Documentation for a Medical Device – a set of documents that confirm the safety and effectiveness of the medical device for the user and its compliance with regulatory requirements. Technical documentation is one of the most important elements of the development, manufacturing, and deployment process for medical devices.

In accordance with the requirements of the Medical Device Regulation No. 753, the technical documentation must ensure the ability to assess the compliance of medical devices with the requirements of the Medical Device Regulation and must include:

• 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 the standards applied in full or in part, including those listed as harmonized European standards and voluntary application of which may be considered as proof of compliance with the Medical Device Regulation, as well as descriptions of decisions taken to meet the Medical Device Regulation requirements when partial application of the mentioned standards;
• if the medical devices are put into circulation in a sterile condition – a description of the methods used and a validation report;
• results of preclinical evaluation;
• results of clinical evaluation according to Annex 10 of the Medical Device Regulation;
• labeling and instructions for use.

All of the above documents enable the manufacturer to ensure the safety and effectiveness of the medical devices being produced, users of medical devices to be confident in their quality, and competent authorities to assess the compliance of medical devices with regulatory requirements.