Registration of software as a medical product in Russia

Contents

• Software as a medical product

• Overview of statutes and regulations

• Criteria for considering software as a medical product

• Is software a medical product?

• Which risk class does software have?

• Examples of software which is a medical product

• Software classification

• Procedure for registration of software as a medical product

• Preparation

• Software tests

• Registration of software as a medical product

• Monitoring after registration

Software as a medical product

Use of software, including AI-based software, can impact clinical decision making. A doctor determines further treatment and diagnostic procedures based on AI opinions. To avoid possible legal ambiguity, use of software for medical purposes requires legal regulation.

We would like to consider rules for registration of software as a medical product in Russia as of 18 April 2022.

In accordance with Article 38 of Federal Law dated 21 November 2011 No. 323-ФЗ (323-FZ), special software is a medical product if its is designed for «prevention, diagnosis, treatment and rehabilitation of diseases, monitoring the state of the human body, for medical research»¹.

Clause 3.18, GOST R 59277-2020 «Artificial Intelligence Systems. Classification of Artificial Intelligence Systems» contains definition of artificial intelligence which requires registration².

Artificial intelligence, AI, means a set of technological solutions which allows simulating human cognitive functions (including self-learning, search for solutions without a predetermined algorithm, and achieving insight) and obtaining results that can be compared at least with human intellectual activity results, when specific practical tasks related to data processing are carried out².

Federal Law No. 323-ФЗ (323-FZ) establishes a statutory requirement for registration of software as a medical product. This procedure is to confirm quality and safety of software when it is put on the market and in further clinical applications¹.

Overview of statutes and regulations

Software is registered in accordance with the following regulations:

• Letter of the Federal Service for Surveillance in Healthcare (Roszdravnadzor) dated 13/02/2020 No. 02I-297 «On Software» establishes criteria for considering products as medical ones for software³.

• Risk classes for software and its classification principles are set out in the order of the Ministry of Health of the Russian Federation dated 6 June 2012 No 4n «On Approval of the Nomenclature Classification of Medical Devices». The order of the Ministry of Health of the Russian Federation dated 7 July 2020 No 686n supplemented the document with section III: «Classification of Software Which Is a Medical Product»⁴.

• Resolution of the Government of the Russian Federation dated 27 December 2012 No.1416 «On Approval of Rules for State Registration of Medical Devices» contains information on stages and time frame for registration of software which is a medical product⁵.

• Technical specifications for software are drafted in accordance with the Order of the Ministry of Health of the Russian Federation dated 19 January 2017 No. 11n «On Approval of Requirements for Contents of Engineering and Operational Documentation of a Medical Device Producer (Manufacturer)». The requirements were supplemented by the order of the Ministry of Health of the Russian Federation dated 20 November 2020 No. 1236N. It included chapters about software which is a medical product in the existing document⁶.

• The software testing procedure is governed by the order of the Ministry of Health of the Russian Federation dated 30 August 2021 No. 885 «On Approval of the Procedure for Compliance Assessment of Medical Products in the form of Engineering Tests, Toxicology Tests, Clinical Trials for State Registration of Medical Products»⁷.

• The order of the Ministry of Health of the Russian Federation dated 15 September 2020 No. 980n establishes the procedure for further monitoring of a medical product safety after registration⁸.

Criteria for considering software as a medical product

In accordance with the letter of the Federal Service for Surveillance in Healthcare (Roszdravnadzor) dated 13/02/2020 No. 02I-297, software is a medical product if ³:

• it is a computer program or its modules irrespective of hardware used, and ways of placing software and providing access to it;

• is not part of another medical product;

• is designed for providing medical aid;

• software results in automatic interpretation, including with the use of AI technologies, or in accordance with parameters set by a health professional which impact clinical decision making, a set of data obtained from medical devices and products permitted to be used in accordance with an established procedure or introduced by health professionals to provide medical aid¹.

Is software a medical product?

We would like to explain the above criteria:

1. Software can be applied using any compatible hardware and an operating system. Access to software may be obtained in any way: via a mobile app, a browser or other programs which use Internet protocols.

2. Diagnostic devices, such as ECG or ultrasound machines, are supplied together with software. In accordance with Roszdravnadzor criteria, such software is not a medical product. Software must be autonomous and be considered separately from medical equipment.

3. Healthcare institutions use a wide range of software for various organizational purposes: statistics, managing work of departments, monitoring rational use of funds. However, software which is designed for providing health care services for a patient (monitoring condition, in-depth diagnostics, assessing treatment effectiveness) is a medical product.

4. The medical information system (MIS) helps organize work with data. It collects and stores information about a patient: full name, sex, age, address, examination data, specialist opinions. At the same time, MIS does not process information and does not influence clinical decision making. If software is a medical product, the situation is different. AI analyzes anonymized data, identifies latent patterns of diagnostic results, and assesses probability of problems. It provides information which will help a doctor to assess a patient’s condition correctly and prescribe treatment.

In accordance with Roszdravnadzor notice, software is a medical product when it meets all four criteria.

Which risk class does software have?

The order of the Ministry of Health of the Russian Federation dated 6 June 2012 No.4n establishes the following potential risk classes for software⁴:

• class 1: low-risk software;

• class 2a: software with moderate risk;

• class 2b: software with increased risk;

• class 3: high-risk software.

At the same time, the order indicates that potential risk class of software does not depend on a medical device or product potential risk with which its is used.

Examples of software which is a medical product

SberMedAI ecosystem integrator develops and implements algorithms which help doctors to make decisions. AI-based software is used for various diagnostic tasks.

• TOP3 Doctor’s Smart Assistant analyzes medical history and electronic medical records, and presents the three most probable diagnoses according to ICD-10⁹;

• CT Stroke: the service identifies circulation problems which are stroke signs in CT brain images¹⁰;

• CT Lungs: the service assesses percentage of affected tissues in CT chest images and identifies the smallest nodules in lung tissues¹¹;

• Mammography: the service analyzes mammograms and shows outlines of suspicious areas¹².

Software classification

Software is classified in accordance with criteria established in the order of the Ministry of Health of Russia dated 7 July 2020 No. 686n⁴:

• Type of information (classification as a particular type of information is based on assessing the impact of software operation results). When information is classified by type, it is necessary to consider whether the information needs to be specified or supplemented to ensure justified clinical decision making. The lawmaker also indicates the need for immediate and timely action as the classification criterion. The greater importance is attached to information, the stronger impact on clinical decision making it has.

• Software application terms (categorization is based on software purpose). The higher the software category is, the more requirements are imposed on health professionals. Medical aid involves higher individual risks. Application category allows user identification: this may be a health professional or a patient who uses software for its intended purpose and (or) under control of a health professional.

Procedure for registration of software as a medical product

The main stages are the following⁵:

1. A software developer submits an application for state registration of a medical product to a registration authority. The applicant submits a set of documents, including information on normative and technical documentation for the medical product and a photo of the software interface.

2. The registration authority checks whether the provided information is complete and makes a decision on starting state registration of medical products.

3. Specifications for expert review of quality, performance and safety of the medical product are executed and submitted to an expert institution.

4. The expert institution conducts an expert review of completeness and results of tests done. Based on its results, an opinion is formed and submitted to a registration authority.

5. The registration authority assesses the opinion to determine whether it meets the specifications for expert review of quality, performance and safety of the medical product.

6. The decision on software registration is made.

In accordance with the Resolution of the Government of the Russian Federation dated 31 May 2018 No.633, amendments were made to the Rules for State Registration of Medical Devices. The procedure for expert review of quality, performance and safety was simplified to one stage¹³.

The applicant does not need to obtain a permission for conducting clinical trials in advance. This allowed reducing the time necessary for medical software registration by 20 business days.

Preparation

The applicant takes measures for preparing engineering and operational documentation, conducts engineering tests and clinical trials, and executes the application.

In accordance with the order of the Ministry of Health of the Russian Federation dated 19 January 2017 No. 11n, the engineering documentation must contain the following⁶:

• software name;

• software functioning principles;

• way of installing software and providing access to it;

• possible risks and ways of managing them;

• results of software testing using test databases;

• measures and means for preventing unauthorized access.

A software developer must also prepare operational documentation. It must be designed for consumers and provided in hard copy and/or in electronic form.

Software tests

Compliance of software which is a medical product is conducted during engineering tests and clinical trials. Their specificities are the following⁷:

• Engineering tests. The developer provides an application to an organization that conducts tests, as well as engineering and operational documentation and copies of preliminary test protocols. After approval of the test program, engineering tests of software are done.

• Clinical trials. Software quality, performance and safety of its use are assessed. Clinical data and documents provided by the developer are also analyzed. If necessary, additional tests are done, and operational documents are refined.

Based on results of engineering tests and clinical trials, assessment reports are prepared. They include information about compliance with regulatory documents and confirmed safety and performance of software⁷.

Registration of software as a medical product

After software tests the expert institution assesses their results. If software is recognized high-quality and safe during the expert review,a relevant opinion is submitted to the registration authority⁵.

After making a decision on state registration of software as a medical product, a registration certificate is executed and issued to the applicant⁵.

In accordance with the Resolution of the Government of the Russian Federation dated 30 September 2021 No.1650, information on software is included in the state register of medical devices and organizations (individual entrepreneurs) that produce medical devices. Information is entered once, and data are available to the public¹⁴.

Medical software registration requires the developer to conduct scrupulous preliminary preparation and comply with regulatory documents. SberMedAI provides developers with services related to medical software certification:

• providing assistance in collecting necessary documents and checking whether they are executed correctly;

• determining the class and potential risk for a medical product;

• executing engineering and operational documentation;

• providing assistance in preparing documents based on clinical trial results;

• tracking an application for the medical product registration.

SberMedAI certification services help accelerate the software registration process. The health care digital product developer is given assistance at all stages: from preparing and submitting the application to getting the registration certificate.

Monitoring after registration

After registering and putting the software on the market, its safety is monitored⁸:

• monitoring is aimed at identifying and preventing adverse effects or reactions which may occur when software is used;

• monitoring is carried out by collecting, processing, registering and analyzing information on adverse events, and making relevant decisions;

• monitoring is carried out by the Federal Service for Surveillance in Healthcare (Roszdravnadzor);

• when relevant information is received, Roszdravnadzor verifies it by taking control measures which involve the medical product producer and the expert institution;

• if information about adverse reactions is confirmed, Roszdravnadzor develops a set of measures to improve software safety.

If the producer does not take necessary measures, Roszdravnadzor can make a decision on withdrawing the medical product from circulation⁸.

Sources

1. Federal Law dated 21 November 2011 No. 323-ФЗ (323-FZ) «On the Basics of Health Protection of the Citizens of the Russian Federation» [Online] // Ministry of Health of the Russian Federation. URL: https://minzdrav.gov.ru/documents/7025-federalnyy-zakon-ot-21-noyabrya-2011-g-323-fz-ob-osnovah-o (request date: 17/03/2022).

2. GOST R 59277-2020 «Artificial Intelligence Systems. Classification of Artificial Intelligence Systems» [Online]. URL: https://docs.cntd.ru/document/1200177292 (request date: 18/04/2022).

3. Letter of the Federal Service for Surveillance in Healthcare (Roszdravnadzor) dated 13/02/2020 No. 02I-297 «On Software» [Online] // Federal Service for Surveillance in Healthcare. URL: https://roszdravnadzor.gov.ru/i/upload/images/2020/2/14/1581670651.93473-1-10822.pdf (request date: 17/03/2022).

4. Order of the Ministry of Health of the Russian Federation dated 6 June 2012 No. 4n «On Approval of the Nomenclature Classification of Medical Devices» (with amendments as of 7 July 2020) [Online] // Electronic Fund of Legal and Normative-Technical Documents. URL: https://docs.cntd.ru/document/902353334(request date: 17/03/2022).

5. Resolution of the Government of the Russian Federation dated 27 December 2012 No.1416 «On Approval of Rules for State Registration of Medical Devices» [Online] // Electronic Fund of Legal and Normative-Technical Documents. URL: https://docs.cntd.ru/document/902390883 (request date: 17/03/2022).

6. Order of the Ministry of Health of the Russian Federation dated 19 January 2017 No.11n «On Approval of Requirements for Contents of Engineering and Operational Documentation of a Medical Device Producer (Manufacturer)» (with amendments as of 20 November 2020) [Online] // Electronic Fund of Legal and Normative-Technical Documents. URL: https://docs.cntd.ru/document/420393735 (request date: 17/03/2022).

7. Order of the Ministry of Health of the Russian Federation dated 30 August 2021 No. 885 «On Approval of the Procedure for Compliance Assessment of Medical Products in the Form of Engineering Tests, Toxicology Tests, Clinical Trials for State Registration of Medical Products»[Online] //Electronic Fund of Legal and Normative-Technical Documents. URL: https://docs.cntd.ru/document/608935477 (request date: 17/03/2022).

8. Order of the Ministry of Health of the Russian Federation dated 15 September 2020 No. 980n «On Approval of the Procedure for Medical Device Safety Monitoring» [Online] // Electronic Fund of Legal and Normative-Technical Documents. URL: https://docs.cntd.ru/document/566006416 (request date: 17/03/2022).

9. TOP-3 ❘ SBERMEDAI: SberMedAI website. [Online]. URL: https://sbermed.ai/en/diagnostic-center/our-algorithms/top-3/ (request date: 17/03/2022)

10. CT Stroke ❘ SBERMEDAI: SberMedAI website. [Online]. URL: https://sbermed.ai/en/diagnostic-center/our-algorithms/ct-stroke/ (request date: 17/03/2022)

11. CT Lungs❘ SBERMEDAI: SberMedAI website. [Online]. URL: https://sbermed.ai/en/diagnostic-center/our-algorithms/ct-lungs/ (request date: 17/03/2022)

12. Mammography❘ SBERMEDAI: SberMedAI website. [Online]. URL: https://sbermed.ai/en/diagnostic-center/our-algorithms/mammography/ (request date: 17/03/2022)

13. Resolution of the Government of the Russian Federation dated 31 May 2018 No.633 «On Amendments to the Rules for State Registration of Medical Devices» [Online] // GARANT.RU. URL: https://base.garant.ru/71959186/ (request date: 17/03/2022).

14. Resolution of the Government of the Russian Federation dated 30 September 2021 No.1650 «On Approval of the Rules for Maintaining the State Register of Medical Devices and Organizations (Individual Entrepreneurs) That Produce Medical Devices, on Amendments to the List of Regulations and Groups of Regulations of the Government of the Russian Federation, Regulations, Certain Provisions of Regulations and Groups of Regulations of Federal Executive Bodies, Regulations, Certain Provisions of Regulations and Groups of Regulations of Executive and Regulatory Government Authorities of the Russian Soviet Federative Socialist Republic and the USSR, Decisions of the State Commission on Radio Frequencies Containing Statutory Requirements to Which Provisions 1, 2 and 3 of Article 15 of Federal Law «On Mandatory Requirements in the Russian Federation», and on Recognizing Certain Regulations of the Government of the Russian Federation as Invalid» [Online] // GARANT.RU. URL: https://base.garant.ru/402868517/ (request date: 17/03/2022).