Order No. 181n by the Ministry of Health of the Russian Federation

Registered with the Ministry of Justice of the Russian Federation on 30 May, 2025,

No. 82421

Order No. 181n by the Ministry of Health of the Russian Federation
dated 11 April, 2025,

ON APPROVAL OF REQUIREMENTS FOR THE CONTENT OF TECHNICAL AND OPERATIONAL DOCUMENTATION OF THE LEGAL MANUFACTURER OF A MEDICAL DEVICE

 

In accordance with Part 3 of Article 38 of the Federal Law dated 21 November, 2011, no. 323-Federal Law "On the Basic Principles of Public Health Protection of the Citizens in the Russian Federation" and sub-clause 5.2.192(1) of paragraph 5 of the Regulations on the Ministry of Health of the Russian Federation, approved by Decree of the Government of the Russian Federation dated  19 June, 2012, no. 608, I hereby order:

 

1.To approve the attached Requirements for the content of technical and operational documentation of the legal manufacturer of a medical device.

 

2. To consider as invalid: order of the Ministry of Health of the Russian Federation dated 19 January, 2017, no. 11n "On approval of requirements for the content of technical and operational documentation of the legal manufacturer of a medical device" (registered by the Ministry of Justice of the Russian Federation on 10 March, 2017, reg. no. 45896);

Order of the Ministry of Health of the Russian Federation dated 20 November, 2020, no. 1236n "On Amendments to the requirements for the content of technical and operational documentation of the legal manufacturer of a medical device, approved by order of the Ministry of Health of the Russian Federation dated 19 January, 2017, no. 11n" (registered by the Ministry of Justice of the Russian Federation on 21 December, 2020, reg. No. 61625).

 

3.To state that the technical and operational documentation of the  legal manufacturer of a medical device, which complies with the requirements for the content of technical and operational documentation of the legal manufacturer of a medical device that were in effect prior to the entry into force of this Order, shall be brought into compliance with the requirements for the content of technical and operational documentation of the legal manufacturer of a medical device approved by this Order, in the event of any changes to the information contained in the registry entry of the state register of medical devices and organizations (individual entrepreneurs) engaged in the production and legal manufacture of medical devices.

 

4.This order enters into force on 1 September, 2025, and shall be in valid until 1 September, 2031.

 

Minister

M.A. MURASHKO

 

APPROVED

by Order of the Ministry of Health

of the Russian Federation

dated 11 April, 2025, no. 181n

 

REQUIREMENTS FOR THE CONTENT OF TECHNICAL AND OPERATIONAL DOCUMENTATION OF THE LEGAL MANUFACTURER OF A MEDICAL DEVICE

I. General

1. The legal manufacturer of a medical device shall develop technical and/or operational documentation in accordance with which the production, manufacture, storage, transportation, installation, setup, application, operation, including maintenance, as well as repair, disposal, or destruction of the medical device are carried out.

2. These Requirements do not apply to the medical devices specified in part 5 of article 38 of the Federal Law of 21 November, 2011, no. 323-Federal Law "On the Basic Principles of Public Health Protection of Citizens in the Russian Federation."

 

II. Content of Technical Documentation of the Legal Manufacturer of a Medical Device, Excluding Software that is a Medical Device or Software Using Artificial Intelligence Technologies that is a Medical Device

 

3. The technical documentation of the legal manufacturer of a medical device (hereinafter referred to as technical documentation), submitted by the legal manufacturer of a medical device or the authorized representative of the legal manufacturer of a medical device as part of the registration dossier for a medical device, excluding software that is a medical device or software using artificial intelligence technologies that is a medical device (hereinafter referred to as software that is a medical device, unless otherwise specified), shall include the following:

 

1.  The name of the medical device and other information allowing the identification of the medical device (including the model (brand) number of the medical device);
2. The intended use of the medical device and the principles of operation;
3. Indications and contraindications for the use of the medical device;
4. Information about potential users of the medical device;
5. Technical characteristics of the medical device;
6. Description of the main functional elements of the medical device, accompanied by diagrams, photographic images, drawings, charts, and other explanations (if available);
7. Description of the constituent parts (assemblies) of the medical device (if available);
8. Description of accessories for medical devices, medical devices or products that are not medical devices, intended for use in combination with the medical device (if available);
9. Information on the absence of restrictions on the interchangeability of medical devices through the use of special technical or software tools or other methods, unless such restriction is intended to ensure the safety and effectiveness of the medical device (if available);
10. Information on the possibility of using the medical device in conjunction with another medical device from a different manufacturer registered in accordance with the requirements of the legislation of the Russian Federation in the field of health protection and the specifics of using the medical device in conjunction with a medical device from another manufacturer (if available)
11. Information on the presence (absence) of direct or indirect contact of the medical device and/or its accessories with the surface of the human body, its mucous membranes, internal environments of the body, for which the specified interaction (contact) is necessary to perform the intended functions of the medical device and/or its accessories;
12. Data on the labeling of the medical device and its packaging (including color layouts of packaging and labels containing the text of the original labeling and additional labeling in Russian applied to medical devices manufactured outside the Russian Federation) (excluding labeling with identification marks <1>);
    
       <1> Rules for labeling certain types of medical devices with identification marks, approved by Decree of the Government of the Russian Federation on 31 May, 2023, no. 894.

 

       13. A list of risks identified in the risk analysis process and a description of methods for managing these risks in order to reduce them to an acceptable level (if available);
       14. Information on the verification and validation of the medical device that was used to demonstrate compliance of the medical device with documents developed and applied in the national standardization system <2>, including results (test reports, analysis of the data obtained):

 

<2> Clause 2 of Article 2 of the Federal Law of 29 June, 2015, no. 162-Federal Law "On Standardization in the Russian Federation."

 

a) Tests in testing laboratories (centers);

b) Laboratory and/or factory tests, including test results under simulated operating conditions;
c) Laboratory tests on animals to confirm the correctness of the concept of the finished medical device <3>;

 

 <3> Subparagraph "c" of clause 11 of the requirements for the content of the technical file for a medical device (excluding software and medical devices for in vitro diagnostics), established in Appendix no. 3 to the Rules for conducting clinical and clinical laboratory trials (studies) of medical devices approved by the Decision of the Council of the Eurasian Economic Commission of 12 February, 2016, no. 29 (hereinafter - the Requirements for the Content of the Technical File for a Medical Device). It is mandatory for the Russian Federation in accordance with the Treaty on the Eurasian Economic Union of 29 May, 2014, ratified by the Federal Law of 3 October, 2014, no. 279-Federal Law "On Ratification of the Treaty on the Eurasian Economic Union" and which entered into force for the Russian Federation on 1 January, 2015.

15. A list of materials of animal and/or human origin, indicating information on their biocompatibility and safety, on the selection of sources (donors), sampling, processing, storage, and handling of these materials (if available);

16. Information on evidentiary materials from the legal manufacturer of the medical device <4>;

 

 <4> Paragraph 3 of clause 4 of the Rules for State Registration of Medical Devices, approved by Decree of the Government of the Russian Federation of 30 November, 2024, no. 1684 (hereinafter referred to as the Rules). In accordance with paragraph 2 of clause 7 of the Decree of the Government of the Russian Federation of 30 November, 2024, no. 1684, the Rules are valid until 31 December, 2026.

17. Information on previous modifications of the medical device or modifications of medical devices in circulation (if information on such modifications of the medical device is used in the technical documentation to prove the conformity of the medical device with safety and effectiveness requirements);

18. Information on the main stages of the design of the medical device and production processes, which is accompanied by diagrams, photographic images, drawings, charts, and other explanations (if available);

19. Information on documents confirming the quality of the medicinal product, pharmaceutical substance, biological material, and other substance, with the use of which it was produced or which are included in the composition of the medical device and intended for use only in accordance with the intended use of the medical device determined by the manufacturer, and issued in accordance with the legislation of the country of origin of the medicinal product, pharmaceutical substance, biological material, and other substance;

20. A description of the sterilization method, information on validation methods for the sterilization process (including tests for biological load, presence of pyrogenic substances, presence of residual sterilizing agent) and on validation of the packaging process (if the medical device is supplied in a sterile form) <5>;

 

   <5> Clause 17 of the Requirements for the Content of the Technical File for a Medical Device.

 

21. Information on the process of design, development, and validation of the software used in the finished medical device (in the case of the presence in the medical device of software that ensures its correct operation and/or use for its intended purpose);

22. Requirements for maintenance and repair of the medical device;
23. Requirements and conditions for the disposal or destruction of the medical device.

4. In the technical documentation of a medical device for in vitro diagnostics, in addition to the information specified in clause 3 of these Requirements, the following must be contained:

1. A description of the intended use of the medical device, including information on:

 

 a)The target analyte, its scientific rationale, an indication of the qualitative, semi-quantitative, or quantitative type of analyte;

b) The functional purpose (including screening, monitoring, diagnosis, or an aid in diagnosis);

c) The specific pathology, condition, or risk factor for the detection, determination, or differentiation of which the in vitro diagnostic medical device is intended;

d) The type of sample being analyzed;

e) The population, demographic aspects of the use of the medical device;

 

2. Information on the level of qualification of potential users of medical devices;
3. Description of the principle of the analytical method or the principle of operation of the medical device, technical characteristics of the analytical equipment;
4. Description of transportation conditions;

5. Information on analytical sensitivity (detection threshold), analytical specificity, diagnostic sensitivity, and diagnostic specificity;

6. Description of measuring procedures, metrological traceability of calibrator and control material values;

7. Data on the stability of the medical device, confirming the stated shelf life, stability during use, and stability during transportation.

 

III. Content of Technical Documentation of the Manufacturer of Software that is a Medical Device

 

5. The technical documentation of the manufacturer of software that is a medical device (hereinafter referred to as technical documentation for software), submitted by the manufacturer of software that is a medical device or its authorized representative as part of the registration dossier for software that is a medical device, shall include:

 

1. The name of the software that is a medical device and other information allowing the identification of the software that is a medical device (including the model(s) (brand(s) of the medical device, the software version, and information on the numbering of versions);

2. Information on the intended use of the software that is a medical device and the principles of its operation;

3. Information on potential users of the software that is a medical device;
4. Information on the interpretation function, the data set source, the hardware platform, the method of placing the software, and the method of providing access to it;
5. Information on the classification of software that is a medical device in relation to the class of potential risk of using the medical device in accordance with the nomenclature classification of medical devices <6>, including specifying the significance of the interpretation results and the conditions of use of the software;

   <6> Order of the Ministry of Health of the Russian Federation of 6 June, 2012, no. 4n "On approval of the nomenclature classification of medical devices" (registered by the Ministry of Justice of the Russian Federation on 9 July, 2012, reg. no. 24852) as amended by orders of the Ministry of Health of the Russian Federation of 25 September, 2014, no. 557n (registered by the Ministry of Justice of the Russian Federation on 17 December, 2014, reg. no. 35201), of 7 July, 2020, no. 686n (registered by the Ministry of Justice of the Russian Federation on 10 August, 2020, registration no. 59225) (hereinafter - Order no. 4n).

 

6. Information on the presence (or absence) of artificial intelligence technologies in the software that is a medical device, and their description;

7. A description of the constituent parts, modules, and blocks of the software that is a medical device, which may be accompanied by structural diagrams of the software architecture;
8. Information on possible changes to the software that is a medical device that affect (or do not affect) its functional purpose and/or principle of operation (if available);

9. Information on how the user can obtain information about the current version of the software that is a medical device and about its update;

10. Characteristics of the accessories of the software that is a medical device, medical devices or products that are not medical devices but are intended to be used in combination with the software that is a medical device, as well as a description of special equipment and/or software, test databases developed by the manufacturer for use of the software (if available);

11. A list of risks identified in the risk analysis process and a description of how to manage these risks to reduce them to an acceptable level <7>;

   <7> Clause 10 of the Requirements for the Content of the Technical File for Software that is a Medical Device, established in Appendix no. 4 to the Rules for Conducting Clinical and Clinical Laboratory Trails (Studies) of Medical Devices, approved by Decision of the Council of the Eurasian Economic Commission of 12 February, 2016, no. 29 (hereinafter - the Requirements for the Content of the Technical File for Software that is a Medical Device). It is mandatory for the Russian Federation in accordance with the Treaty on the Eurasian Economic Union of 29 May, 2014, ratified by Federal Law no. 279- Federal Law of 3 October, 2014 "On Ratification of the Treaty on the Eurasian Economic Union" and entered into force for the Russian Federation on 1 January, 2015.

 

12. Technical specifications of the software that is a medical device;
13. Hardware system requirements necessary for the operation of the software that is a medical device (supported operating systems, hardware platforms, required RAM, required disk space, additional requirements for hardware and software);
14. Information on data exchange protocols for using the software that is a medical device together with other medical devices and/or accessories;
15. Information on the procedure for installing and uninstalling the software that is a medical device;

16. Requirements for the training or qualifications of persons installing the software that is a medical device (if applicable);

17. Data on the labeling of the software that is a medical device and its packaging (if applicable);

18. Information on the verification and validation of the software that is a medical device, including reports on testing the software and results of tests on test databases;
19. Information on the life cycle processes of the software, including information on the main stages of software development, which may be accompanied by diagrams, photographic images, drawings, charts and other explanations <8>;

   <8> Clause 6 of the Requirements for the content of the technical file for the software that is a medical device.

 

20. Information about similar software that is a medical device, or the lack of such information;
21. A list of measures and means of protection against unauthorized access to the software, as well as measures to ensure its cybersecurity, including <9>:

 

<9> Subparagraph "ж" of clause 2 of the Requirements for the content of the technical file for the software that is a medical device.

 

a) Information about potential risks of cybersecurity threats (including asset, threat and vulnerability identification);

b) Information on the procedure for restricting access for all possible levels, indicating the methods by which such restriction is achieved (access only for trusted users, access through user authentication);

c) The degree and possibility of the influence of threats and vulnerabilities on the functionality of the device and potential consumers (users);
d) Information on the use of automatic synchronization methods to end sessions in the system, if this is necessary for the environment in which the software is used;

e) Information on the use of a multi-level authorization model and differentiation of rights based on the user's role or the device's role;

f) Information on the technical and software protection tools used in the software that is a medical device;

g) The procedure for carrying out user authentication before allowing updates to the software that is a medical device, including those affecting the operating system and applications;
h) Information on the need to use systematic procedures for authorized users when installing and updating the software that is a medical device;

i) Information on the need to use protection against malicious software (antivirus software) if such tools are not provided by the manufacturer of the software that is a medical device, which should be used in conjunction with other software;

j) Information on the use of cryptographic information protection tools (if available);
k) Information on the need to use the function of archiving, backing up (duplicating) data on the organization's servers using an authenticated privileged user;

l) Information on the tools used to protect against illegal distribution (if available);

22) Information on clinical guidelines used by the algorithm of the software that is a medical device (if available);

23) A list of national and interstate standards applied by the manufacturer of the software;
24) Information on the presence (or absence) in software that uses artificial intelligence technologies and is a medical device, of a built-in function for automatic transmission to the automated information system of the Federal Service for Surveillance in Healthcare of information on processed data, the results of the operation of the software, as well as information provided by the procedure for reporting by medical device market participants on all cases of detection of side effects not specified in the instructions for use or the user manual, adverse reactions to its use, peculiarities of interaction of medical devices with each other, facts and circumstances posing a threat to the life and health of citizens and healthcare workers during the use and operation of medical devices <10>;

 

<10> Clause 87 of the Rules.

 

25) Information on the initial release or the latest revision of the technical documentation for the software.

 

IV. Content of the Operational Documentation of the Legal Manufacturer of a Medical Device, Excluding Software that is a Medical Device

6. The operational documentation of the legal manufacturer of a medical device, excluding software that is a medical device (hereinafter - operational documentation), submitted by the manufacturer or the authorized representative of the manufacturer, as part of the registration dossier for the medical device, excluding software that is a medical device, shall contain:

1. The name of the medical device;

2. The full and abbreviated names (if any), including the company name, the legal form of the legal entity, the address of the location or the last name, first name and patronymic (if any), the details of the identity document, the address of registration at the place of residence of the individual entrepreneur, as well as the telephone number and e-mail address (if any) of the legal entity or individual entrepreneur - with respect to the legal manufacturer of the medical device;
    The full and abbreviated (if any) names, including the company name, the legal form of the legal entity, the address of registration, as well as the telephone number and e-mail address (if any) of the legal entity - with respect to the authorized representative of the legal manufacturer of the medical device;

3. Information on the intended use of the medical device, indicating the potential user (including a healthcare professional);

4. Information on the functional characteristics and purpose of the medical device;
5. Information on the risks of using the medical device, contraindications, expected and predictable side effects associated with the use of the medical device as intended;
6. Information on the technical characteristics of the medical device;
7. A description of accessories for medical devices, medical devices or products that are not medical devices but are intended to be used in combination with the medical device (if available);

8. Information on the presence in the medical device of a medicinal product for medical use, materials of animal and/or human origin;

9. Information on the requirements for installation, mounting, setup, calibration and other actions necessary for putting the medical device into operation;

10. Requirements for the premises in which the medical device is to be installed (mounted), as well as requirements for the training or qualification of persons performing the installation (mounting) of the medical device (if available);

11. Information for verifying the correctness of the installation (mounting) of the medical device and its readiness for safe operation, including:

  a) The content and frequency of maintenance, including cleaning and disinfection of the medical device;

  b) A list of information, keys, access passwords, programs provided by the manufacturer, necessary for the installation, setup, operation and maintenance of the medical device;

c) A list of consumables (components, reagents), as well as the procedure for their application and replacement;

d) The necessity of calibration to ensure the proper and safe operation of the medical device during its service life;

e) Methods for reducing the risks associated with the installation, calibration or maintenance of the medical device;

f) Information on the installation, setup, adjustment, calibration and other actions necessary for putting the medical device into operation and its correct operation (application);
g) Information on the list of basic characteristics for operation (application) of the medical device, conditions of transportation and storage (including temperature and humidity, lighting and other characteristics);

h) A list of documents developed and applied in the national standardization system used by the  legal manufacturer of the medical device;

 

12. Information on the sterile condition of the medical device, the method of its sterilization, and on actions to be taken in case of damage to the sterile packaging (if the medical device is supplied in a sterile condition) or, if the medical device is supplied non-sterile, an indication of the need to sterilize it before use;
13. Information on the requirements for processing the medical device for its reuse, including cleaning, disinfection, packaging and, if necessary, a method of re-sterilization (if the medical device is intended for multiple use), as well as criteria for the unsuitability of the medical device for use;
14. Information necessary for the identification of medical devices in order to obtain a safe combination, and information on known restrictions on the joint use of medical devices (for medical devices intended for use together with other medical devices and/or accessories);

15. Information on the absence of restrictions on the interchangeability of medical devices through the use of special technical or software tools or other methods, unless such restriction is intended to ensure the safety and effectiveness of the medical device (if available);

16. Information on the possibility of using the medical device in combination with another medical device from a different manufacturer, registered in accordance with the requirements of the legislation of the Russian Federation in the field of health protection, and on the specific features of the combined use of the medical device with a medical device from a different manufacturer (if available);
17. Information on the nature, type, and (if necessary) on the intensity (if available) and distribution of radiation (including electromagnetic, ionizing) of the medical device, and on ways to protect consumers and third parties from unintentional radiation during the operation of the medical device (if the medical device creates a hazardous or potentially hazardous level of radiation when used as intended);
18. Information on precautions taken in the event of:

  a) A malfunction of the medical device, a failure in its operation or deviations in functioning that may affect the safety of the medical device, including those determined by external signs;

b) Exposure to the functioning of the medical device of external factors related to the use of the medical device in combination with other medical devices and/or equipment, or predictable factors such as external electromagnetic fields, electrostatic discharges, radiation (including electromagnetic, ionizing), atmospheric pressure and its changes, humidity and air temperature;
c) The risk of electromagnetic interference created by the medical device for other medical devices, equipment and communications during the conduct and clinical evaluation of the results of diagnosis, treatment or during its intended use (including electromagnetic radiation of the medical device that affects other equipment);

19. Warnings and/or precautions taken by the consumer when using a medical device containing a medicinal product for medical use, materials of animal and/or human origin, materials that are carcinogenic, mutagenic or toxic, the possible release or leaching of which leads to sensitization, allergic reaction or negatively affects reproductive function;

20. Warnings and/or precautions taken by the consumer when disposing of the medical device, accessories and consumables used with it (if available), including information on the infectious, microbial, environmental or physical hazards of the medical device;

21. Information on the circumstances under which the consumer should consult a healthcare professional;

22. Information on the original release or latest revision of the operational documentation;
23. Requirements and conditions for the disposal or destruction of the medical device.

7. In the operational documentation of a medical device for in vitro diagnostics, in addition to the information specified in clause 6 of these Requirements, the following shall be contained:

1. Information on the purpose of the medical device:

 

a) description of the target analyte, indicating the qualitative, semi-quantitative or quantitative type;

 b) The specific disorder, condition or risk factor for the detection, determination or differentiation of which the medical device is intended;

 c) The type of sample being analyzed;

 

2. Information on the intended use for clinical laboratory diagnostics;

3. Description of the requirements for performing testing using the medical device, description of reagents, calibrators and control materials;

4. A list of materials and special materials that are required for testing (analysis) but are not included in the delivery set of the medical device;

5. Information for identifying medical devices for the purpose of obtaining a safe combination and (or) information on known restrictions on the joint use of medical devices for their intended purpose (for medical devices intended for use in combination with other medical devices, including medical devices for in vitro diagnostics);
6. Information on the stability characteristics of the medical device (including storage conditions, shelf life after opening the primary packaging);
7. Information for consumers of the medical device about precautions taken where necessary, as well as precautions and/or measures taken with respect to potentially infectious material contained in the medical device;

8. Information on the intended use of the medical device for single use only;
9. Information on the necessary processing of the medical device for the purposes of its reuse, including cleaning, disinfection, packaging and, if necessary, the method of resterilization (if the medical device is intended for multiple use);
10. Information on the conditions necessary for the collection, processing and preparation of samples, data on the stability of the analyzed samples, including conditions and duration of storage, conditions of transportation, restrictions on freeze-thaw cycles;

11. Information on the preparation for intended use, operation of the medical device;
12. Information on the traceability of values set for calibrators or control materials, which is ensured through available reference measurement methods and/or standards;
13. A description of the testing procedure, including calculations and interpretations of test results, and, if necessary, information on the advisability of conducting confirmatory tests;

14. Analytical performance characteristics: sensitivity, specificity, accuracy, repeatability, reproducibility, limit of detection and range of measurement, including information on the effect of known interferents, on the limitations of the method and the use of available reference materials and methods of analysis;

15. Clinical performance characteristics: diagnostic sensitivity and diagnostic specificity;
16. Biological reference interval for the use of the medical device;
17. Information on interfering substances or limitations related to the sample that may affect the test result;

18. A warning and/or special precautions regarding the safe disposal of the medical device and its accessories, containing:

 

a) Infectious or microbial risks, including the possibility of contamination of consumables with infectious agents of human origin;

b) Environmental risks associated with potentially hazardous materials and substances;
 c) Physical risks (including the possibility of explosion or fire);

 

19. Information (in relation to a medical device intended for self-testing by the consumer):

a) About the testing procedure (preparation of reagents, collection (preparation) of the sample, requirements for the performance and interpretation of test results);
b) About the description of the consumer's actions in case of a positive, negative or indefinite test result;

c) About test errors and the possibility of obtaining false-positive or false-negative test results, as well as about factors affecting the test result;

d) About the inadmissibility of making medical decisions by the consumer based on the test results without prior consultation with a healthcare professional.

8. The operational documentation is provided by the manufacturer to the consumer for review on paper (together with the medical device or separately from it) and in the form of an electronic document by posting it on the information and telecommunications network "Internet."

The operational documentation may be provided to the consumer for review in the form of an electronic document by placing it on a screen that is part of the medical device.

With respect to medical devices of potential risk classes 1 and 2a <11>, the consumer may be provided with operational documentation in a reduced volume, necessary and sufficient for the safe use of the medical device as intended.

   <11> Order N 4н.

 

V. Content of operational documentation of the manufacturer of software that is a medical device

9. The operational documentation of the manufacturer (producer) for software that is a medical device (hereinafter - the operational documentation for software) submitted by the manufacturer (producer) of the software that is a medical device or its authorized representative as part of the registration dossier for the software that is a medical device shall contain the following:

 

1. The name of the software that is a medical device and other information allowing to identify the software that is a medical device (including the model (brand), the version of the software that is a medical device, and also information about the numbering of versions of such software);

2. Information about the developer of the software that is a medical device - the full and abbreviated (if any) names, including the trade name, the organizational and legal form of the legal entity, the address of location or the last name, first name and patronymic (if any), the details of the identity document, the address of registration at the place of residence of the individual entrepreneur, and also the telephone number and e-mail address (if any) of the legal entity or individual entrepreneur;
3. Information about the manufacturer (producer) of the software that is a medical device - the full and abbreviated (if any) names, including the trade name, the organizational and legal form of the legal entity, the address of location or the last name, first name and patronymic (if any), the details of the identity document, the address of registration at the place of residence of the individual entrepreneur, and also the telephone number and e-mail address (if any) of the legal entity or individual entrepreneur;
4. Information about the authorized representative of the manufacturer of the software that is a medical device - the full and abbreviated (if any) names, including the trade name, the organizational and legal form of the legal entity, the address of location or the last name, first name and patronymic (if any), the details of the identity document, the address of registration at the place of residence of the individual entrepreneur, and also the telephone number and e-mail address (if any) of the legal entity or individual entrepreneur;

5. Information about the purpose of the software that is a medical device and principles of its operation;

6. Information about potential consumers (users) of the software that is a medical device;
7. Information about the interpretation function, the source of the data set, the hardware platform, the way of placing the software that is a medical device, and providing access to it;

8. Information about the classification of the software that is a medical device <12> regarding the class of potential risk of using the medical device in accordance with the nomenclature classification of medical devices <12>, including indicating the significance of the results of the interpretation of the software that is a medical device and the conditions for the application of the software that is a medical device;

<12> Section III "Classification of Software that is a Medical Device" of the nomenclature classification of medical devices by classes depending on the potential risk of their use, approved by Order 4n.

 

9. Information on the presence (or absence) of artificial intelligence technologies in the software that is a medical device, and their description;
10. A description of the constituent parts, modules, and blocks of the software that is a medical device;

11. Information on possible changes to the software that is a medical device that affect (or do not affect) its functional purpose and/or principle of operation (if available);
12. Information on how the user can obtain information about the current version of the software that is a medical device and the requirements for its updating;
13. Characteristics of the accessories of the software that is a medical device, medical devices or products that are not medical devices but are intended for use in combination with the software that is a medical device, as well as a description of special equipment and/or software, test databases developed by the manufacturer (producer) for the use of the software (if available);

14. A list of risks for the consumer identified in the process of risk analysis;
15. Technical characteristics of the software that is a medical device;
16. Hardware system requirements necessary for the operation of the software that is a medical device (supported operating systems, supported hardware platforms, required RAM, required disk space, additional requirements for hardware and software);
17. Information on data exchange protocols for using the software that is a medical device together with other medical devices and/or accessories;

18. Information on the procedure for installation and uninstallation of the software that is a medical device;

19. Requirements for the training or qualification of persons carrying out the installation of the software (if available);

20. Data on the labeling of the software that is a medical device and its packaging (if available);

21. Information needed to identify the software to ensure safe combination and information about known restrictions on the joint use of the software (for software intended for use with other medical devices and/or accessories);

22. Information on the measures taken in case of possible errors and failures of the software that is a medical device;

23. Information about the circumstances (consequences) of using the software that is a medical device, in which the user should consult with a healthcare professional or the technical support service;

24. Information on the requirements for the implementation of technical support and maintenance of the software;

25. A list of measures and means of protection against unauthorized access to the software, as well as measures to ensure its cybersecurity, including <13>:

    <13> Subparagraph "ж" of clause 2 of the Requirements for the Content of the Technical File for Software that is a Medical Device.

    a) Information on potential risks of cybersecurity threats (including identification of assets, threats, and vulnerabilities);

  b) Information on the procedure for restricting access for all possible levels, indicating the methods by which such restriction is achieved (access only for trusted users, access through user authentication);

c) The degree and possibility of the influence of threats and vulnerabilities on the functionality of the software and the intended users;

d) Information on the use of automatic synchronization methods to end sessions in the system, if this is necessary for the environment of use of the software;

e) Information on the use of a multi-level authorization model and differentiation of rights based on the user's role or the device's role;

f) Information on the technical and software tools for protection used in the software;
g) The procedure for carrying out user authentication before allowing updates to the software, including updates affecting the operating system and applications;
h) Information on the need to use systematic procedures for authorized users when installing and updating the software;

 i) Information on the need to use protection against malicious software (antivirus software), if such means are not provided by the manufacturer (producer) of the software, which should be used in conjunction with other software;

j) Information on the use of cryptographic information protection tools of the software (if available);

k) Information on the need to use the function of archiving, backing up (duplicating) data on the organization's servers using an authenticated privileged user;
m) Information on the means used to protect against illegal distribution (if available);

26. Information on clinical guidelines used by the algorithm of the software (if available);
27. List of national and interstate standards applied by the manufacturer (producer) of the software;

28. Information on the presence (or absence) in software that uses artificial intelligence technologies, of a built-in function for automatically transmitting to the automated information system of the Federal Service for Surveillance in Healthcare information on processed data, results of the operation of the software, and information provided by the procedure for reporting by medical device market participants on all cases of detection of side effects not specified in the instructions for use or the user manual, adverse reactions during its use, peculiarities of the interaction of medical devices with each other, facts and circumstances that create a threat to the life and health of citizens and medical workers during the use and operation of medical devices <14>;

 

  <14> Clause 87 of the Rules.

 

29. Information on the initial release or the latest revision of the operational documentation for the software.

 

10. Operational documentation for the software is provided for review to the consumer on paper (together with the software, or separately from it) and/or in electronic form by posting it on the information and telecommunication network "Internet" and/or on an electronic medium.

Operational documentation for the software may be provided to the consumer for review in electronic form by placing it on a screen that is part of the medical device.