New criteria for classifying software as medical devices
Pepeliaev Group advises that the Russian Federal Service for Surveillance in Healthcare (“Roszdravnadzor”) has issued information letter No. 02I-297/20 “On software” dated 13 February 2020, and that information letter No. 01I-2358/15 “On registering software” dated 31 December 2015, which was previously in effect, has been revoked.
For over a year, Pepeliaev Group’s healthcare practice, teaming up with the Competence Centre of Skolkovo Foundation, has been actively involved in providing legal support for amending the regulation relating to Software as a Medical Device (SaMD), including at the stage of a specialised working group established at Roszdravnadzor. The first measurable result of the extensive work was an information letter from Roszdravnadzor containing new criteria for classifying software as medical devices.
The letter excludes a significant number of software products, which do not directly relate to providing medical aid, from the regulation of medical devices. The current version of the letter has been brought in line with international cutting-edge approaches to classifying software as medical devices and is already being used by Roszdravnadzor to regulate activities in the area of the circulation of medical devices, including matters relating to registration.
Software is now considered to be a medical device only if it simultaneously meets the following conditions:
- it is a program for a computer or a computer module;
- it is not an integral part of another medical device;
- it is intended by the manufacturer to provide medical aid; and
- its functioning results in the automatic interpretation of data received from medical devices or entered by a healthcare specialist.
The letter provides a separate clarification concerning the methods and technologies that should not be considered interpretation of data for the purpose of determining the status of software as a medical device. Accordingly, if the software performs only the functions listed in the letter, it will not be categorised as a medical device since the criterion of automatic interpretation is not met. Such functions, for instance, comprise the following: displaying data received from the medical device; performing calculations in accordance with the input formulae; conversion between measurement units; drawing up statistical reports and schedules; paintbrush or drawing editors; signalling when deviations occur, provided that the source data may be controlled and parameters for identifying such deviations may be specified; and establishing business processes and preparing reports for medical institutions.
For the convenience of the application of the above criteria, the letter describes examples of software meeting all the established criteria and relating to medical devices. Such software is used directly to provide medical aid and may be connected both with diagnostics and any subsequent medical manipulations. Such examples comprise, among others, the following:
- software to support medical decision-making in the case of a stroke;
- software to assist a doctor in diagnosing malignant growths;
- software to assist a doctor in planning the technique of performing surgeries; and
- software to develop an individual rehabilitation programme.
In addition, the letter sets out examples of software which, on the contrary, does not fall within the class of medical devices even if such software is connected with the activities of medical institutions. Such software may be intended, for example, to support the business and administrative tasks of medical institutions, to support a healthy lifestyle for the public, serve to record, to plan and control the performance of the scheduled maintenance and repair of medical devices, and to be used for other purposes not directly related to providing medical aid.
The current version of the criteria for classifying software as medical devices has been submitted to the working group of the Eurasian Economic Commission to be agreed with the member states so that the drafted proposals may be implemented at the supra-national level in the form of amendments being made to Recommendations No. 25 of the Board of the Eurasian Economic Commission dated 12 November 2018 “On the criteria of classifying products as medical devices within the Eurasian Economic Union”.
What to think about and what to do
The new regime of classifying software as medical devices introduces changes in the activities of manufacturers of medical software and should be taken into account when planning future actions.
Pepeliaev Group’s lawyers are ready to provide comprehensive legal assistance in connection with the new developments and support in assessing whether software meets the criteria of a medical device, including as concerns its relationship with other medical devices. We advise on all questions which may arise in connection with software being registered as a medical device.