The Commission of the Federal State Budgetary Institution “VNIIMT” of Roszdravnadzor for issuing conclusions on requests related to the circulation of medical devices considered the Criteria for Attribution of Products to Medical Devices in terms of software and concluded that the Criteria are harmonized in accordance with international classifications and contain the criteria to refer the software to medical devices.
The Criteria for the attribution of products to medical ones in terms of software are proposed in the following version:
A software is a medical product provided that it meets all of the following criteria:
- it is a computer program or its modules regardless of the hardware platform used and the way the software is located and accessed;
- it is not part of another medical device;
- it is intended by a manufacturer to provide medical care;
- The result of the software action consists in automatic interpretation, including the use of artificial intelligence technologies, or according to the parameters set by a medical professional, affecting clinical decision-making, a set of data obtained from medical devices admitted to circulation in the prescribed manner or entered by medical professionals for the provision of medical care.
Examples of methods and technologies used in software functions that are not data interpretation:
- displaying the data received from the medical device, including those in the specified format;
- calculation according to predetermined formulas;
- conversion between different units;
- generation of statistical reports and charts;
- raster or vector image editor;
- signalization of data deviations if it is possible to display the initial data and if the user sets the parameters of the deviation signalization;
- functions for creating screen forms, business processes, reporting and other representations that are used to automate the business processes of the medical organization during the operation of the software.
The document also provides examples of software (including functions, data set sources, purposes, platforms, access modes, etc.) that is/are not medical devices.