On February 14, 2020, Federal Service for Surveillance in Healthcare (Roszdravnadzor) published new criteria for classifying software as medical devices.
Roszdravnadzor has officially notified the market that letter No. 01I-2358/15 "On registration of software" dated December 30, 2015, has been cancelled. Instead, a new information letter dated February 13, 2020, No. 02I-297/20 was issued, which contains new criteria for software classification as a medical device. The document is available at (in Russian): https://roszdravnadzor.ru/medproducts/registration/documents/65752.
Its release was the result of the fruitful and constructive work of the National Medical Knowledge Base Association and representatives of the professional community, Roszdravnadzor and its subordinate expert institutes.
The work on this letter started on September 25, 2018, when the National Medical Knowledge Base, together with the Skolkovo Foundation and Roszdravnadzor, held a “Registration of software as a medical device: problems and solutions” roundtable. During this roundtable, the problems were discussed and institutions agreed to work together on its solution.
The round table was moderated by Alexander Gusev, Chief Business Development Officer of our company.
Then there was a block of various joint events, from a meeting in the Federation Council to various other meetings and public discussions. The timeline of this work is presented on the National Medical Knowledge Base website at (in Russian): http://nbmz.ru/rabochaja-gruppa/.
The direct practical effort on the development of new documents was launched at the meeting "Legal regulation of the circulation of medical device software", which took place on October 17, 2019, under the leadership of the head of Roszdravnadzor M.A. Murashko. At this meeting, it was decided to create a special working group on the issue of establishing criteria for software classification as a medical device. The work was carried out quite actively: there were nine meetings at which experts and market representatives discussed this difficult topic and worked on the best option. The result of the work was the text of the criteria, which was approved by Roszdravnadzor in its letter.
The most important change: is it a clear and transparent set of criteria that helps to determine which software is a medical device and which is not? If the software is intended to provide medical care by the manufacturer and if it somehow interprets the medical information, then such software should be referred to as a medical device. If there are no such features, then this is ordinary software and it is not necessary to register it as an MD. Clinical decision support systems and medical software based on AI technologies are classified as medical devices unambiguously. Therefore, their mandatory testing, expertise and state registration are required.
As Alexander Gusev noted in a Facebook post: “This is very important for the market. For example, now the ordinary systems for maintaining electronic medical records (EHR), medical information systems, electronic registries, etc. are not medical devices if they do not contain clinical decision support functions and do not form any prompts to the doctor or somehow interpret the medical information. What is more, all administrative software, reference books, mobile applications for patients on a healthy lifestyle and a number of other types of software are taken out of the concept of MD."