Order No. 421n by the Ministry of Health of the Russian Federation

"On Approval of the Procedure for Conducting Conformity Assessment of Medical Devices in the Form of Technical Tests, Toxicological Studies, Clinical Trials for the Purpose of State Registration of Medical Devices"

Registered with the Ministry of Justice of the Russian Federation on June 1, 2026
Registration No. 86767

In accordance with Part 8 of Article 38 of Federal Law No. 323-FZ dated November 21, 2011 "On the Fundamentals of Health Protection for Citizens in the Russian Federation" and subparagraph 5.2.187 of paragraph 5 of the Regulation on the Ministry of Health of the Russian Federation, approved by Decree of the Government of the Russian Federation No. 608 dated June 19, 2012, I hereby order:

1. To approve the attached Procedure for Conducting Conformity Assessment of Medical Devices in the Form of Technical Tests, Toxicological Studies, Clinical Trials for the Purpose of State Registration of Medical Devices.
2. To declare invalid the Order of the Ministry of Health of the Russian Federation No. 885n dated August 30, 2021 "On Approval of the Procedure for Conducting Conformity Assessment of Medical Devices in the Form of Technical Tests, Toxicological Studies, Clinical Trials for the Purpose of State Registration of Medical Devices" (registered by the Ministry of Justice of the Russian Federation on November 12, 2021, registration No. 65787).
3. To establish that the conformity assessment of medical devices in the form of technical tests, toxicological studies, clinical trials for the purpose of state registration of medical devices, applications for which are submitted by the manufacturer of the medical device or an authorized representative of the manufacturer to a testing laboratory (center) or medical organization before the effective date of this Order, shall be carried out in accordance with the requirements of the procedure for conducting conformity assessment of medical devices in the form of technical tests, toxicological studies, clinical trials for the purpose of state registration of medical devices that was in effect before the effective date of this Order.
4. This Order shall enter into force on September 1, 2026, and shall be valid until September 1, 2032.

Minister
M.A. Murashko

Approved by Order of the Ministry of Health of the Russian Federation No. 421n dated May 13, 2026

PROCEDURE FOR CONDUCTING CONFORMITY ASSESSMENT OF MEDICAL DEVICES IN THE FORM OF TECHNICAL TESTS, TOXICOLOGICAL STUDIES, CLINICAL TRIALS FOR THE PURPOSE OF STATE REGISTRATION OF MEDICAL DEVICES

I. General Provisions

1. Conformity assessment of medical devices, which is conducted in the form of technical tests, toxicological studies, clinical trials of medical devices for the purpose of state registration of medical devices, including for the purpose of amending documents contained in the registration dossier for a medical device (hereinafter referred to as conformity assessment, technical tests, toxicological studies, clinical trials, respectively), is carried out in accordance with this Procedure, subject to compliance with the requirements of the legislation of the Russian Federation on the circulation of medical devices, regulatory and technical documentation of the manufacturer of the medical device, as well as documents of the national standardization system containing requirements, rules and methods of research (tests) and measurements of medical devices.
2. Based on the results of the conformity assessment, the following are prepared:
   a) Protocol of Technical Tests of a Medical Device or a Medical Device for In Vitro Diagnostics (recommended template is given in Appendix No. 1 to this Procedure);
   b) Protocol of Toxicological Studies of a Medical Device (recommended template is given in Appendix No. 2 to this Procedure);
   c) Medical Device Clinical Trial Results Assessment Report (recommended template is given in Appendix No. 3 to this Procedure);
   d) Report on the Evaluation of the Results of Clinical Trials of a Medical Device for In Vitro Diagnostics (recommended template is given in Appendix No. 4 to this Procedure).
3. The results of the conformity assessment are prepared on paper or in the form of an electronic document.
   The preparation of the conformity assessment results specified in subparagraphs "a" and "b" of paragraph 2 of this Procedure is carried out in accordance with the requirements of applicable documents of the national standardization system.
4. The manufacturer of the medical device or the authorized representative of the manufacturer (hereinafter referred to as the Applicant) independently determines the testing laboratory (center) accredited in the national accreditation system (hereinafter referred to as the Testing Organization) that conducts technical tests and/or toxicological studies, taking into account its scope of accreditation, as well as meeting the requirements established by the Rules for State Registration of Medical Devices, approved by Decree of the Government of the Russian Federation No. 1684 dated November 30, 2024 "On Approval of the Rules for State Registration of Medical Devices" (hereinafter referred to as the Rules), valid until December 31, 2028, and the medical organization conducting clinical trials of medical devices (hereinafter referred to as the Medical Organization), except for cases provided for in paragraph 24 of the Rules.

Testing Organizations and Medical Organizations, when conducting technical tests and/or toxicological studies, as well as clinical trials, ensure the principle of impartiality and are not in any dependence on the Applicant or other persons interested in the results of the tests (studies).

Technical tests are not carried out in relation to reagents, reagent kits, control materials, calibrators, washing solutions, diluents, plastic consumables used with reagents for in vitro diagnostics, and culture media.

II. Conformity Assessment of Medical Devices in the Form of Technical Tests (Except for Medical Devices for In Vitro Diagnostics)

5. To conduct technical tests, the Applicant or a person authorized by the Applicant submits to the Testing Organization (directly to the Testing Organization, or by registered mail with return receipt requested, or in the form of an electronic document signed with an electronic signature in accordance with Federal Law No. 63-FZ dated April 6, 2011 "On Electronic Signatures" (hereinafter referred to as Electronic Signature) of the Applicant, by sending it to the Testing Organization's email address) an application for conducting technical tests of the medical device, specifying the information provided for in subparagraphs "a" - "l", "s" - "u", "x" (as applicable) and "ch" of paragraph 64 of the Rules, along with the documents specified in subparagraphs "a" - "d", "k" - "m" and "o" of paragraph 65 of the Rules, as well as a copy of the document confirming the authority to submit such an application on behalf of the Applicant (in case the application for conducting technical tests is submitted by a person authorized by the Applicant).

If the documents for the medical device specified in this paragraph are drawn up in a foreign language, they are submitted with a certified translation into Russian.

6. The Testing Organization reviews the application for conducting technical tests of the medical device and the documents specified in paragraph 5 of this Procedure within a period not exceeding 10 working days from the date of their receipt and decides on the possibility (impossibility) of conducting technical tests of the medical device.

If the Testing Organization decides on the possibility of conducting technical tests, the Testing Organization notifies the Applicant in writing (sending a notification by registered mail with return receipt requested, or in the form of an electronic document signed with the electronic signature of the head of the Testing Organization or a person authorized by the head of the Testing Organization, by sending it to the Applicant's email address specified in the application for conducting technical tests of the medical device) within three working days from the date of such decision. Thereafter, jointly with the Applicant, it draws up a test program, which is approved by the head of the Testing Organization, and sends the Applicant a draft contract for conducting such tests.

7. If a decision is made on the impossibility of conducting technical tests due to the lack of grounds for conducting technical tests (lack of accreditation) and/or the technical capability of the Testing Organization (malfunction or scheduled maintenance of the Testing Organization's equipment), or non-compliance of the submitted application for conducting technical tests of the medical device and the documents specified in paragraph 5 of this Procedure with the requirements of this Procedure, the Testing Organization notifies the Applicant in writing thereof (sending a notification by registered mail with return receipt requested, or in the form of an electronic document signed with the electronic signature of the head of the Testing Organization or a person authorized by the head of the Testing Organization, by sending it to the Applicant's email address specified in the application for conducting technical tests of the medical device) within three working days from the date of such decision, stating the reasons for refusing to conduct technical tests.
8. After the approval of the test program by the head of the Testing Organization, as well as the signing of the contract for conducting technical tests, the Applicant submits to the Testing Organization:
   a) The medical device together with accessories necessary for the intended use of the medical device or its models (modifications) (hereinafter referred to as Accessories) (in quantities according to the requirements of the national standardization system documents and the approved test program);
   b) Special equipment developed by the manufacturer for technical tests of a specific medical device and specified by it in the technical documentation (if available) (except for software that is a medical device and/or software using artificial intelligence technologies that is a medical device);
   c) Special equipment and/or software, test databases developed by the manufacturer for technical tests of a specific medical device and specified by it in the technical documentation (if available) (for software that is a medical device and/or software using artificial intelligence technologies that is a medical device).
9. For medical devices whose technical tests or installation (commissioning) require permits (including licenses), major repairs, construction of individual capital structures, technical tests may be conducted by the Testing Organization on the premises of the manufacturer or in an organization where the medical device is located and/or permitted for use in accordance with the legislation of that country.
10. Technical tests of medical devices are conducted by the Testing Organization within a period not exceeding 30 working days from the date the Applicant provides the Testing Organization with the medical device, accessories, and special equipment and/or software, test databases (if available) specified in paragraph 8 of this Procedure, provided that the Applicant pays for the Testing Organization's services in accordance with the concluded contract. In cases where a longer period is provided for by the method of technical tests, the period for conducting technical tests is extended by decision of the head of the Testing Organization or a person authorized by the head of the Testing Organization for no more than 20 working days, and the Testing Organization notifies the Applicant thereof (by registered mail with return receipt requested, or in the form of an electronic document signed with the electronic signature of the head of the Testing Organization or a person authorized by the head of the Testing Organization, by sending it to the Applicant's email address specified in the application for conducting technical tests of the medical device) within three working days from the date of such decision.
11. When conducting technical tests in accordance with the test program specified in paragraph 8 of this Procedure, the following is carried out:
    a) Assessment of the compliance of the characteristics (properties) of the medical device with the requirements of regulatory documentation, technical and operational documentation of the manufacturer for the medical device;
    b) Determination of the potential risk class of using the medical device in accordance with the nomenclature classification of medical devices;
    c) Assessment of the completeness and sufficiency of the information contained in the application for conducting technical tests of the medical device and the documents specified in paragraph 5 of this Procedure;
    d) Preparation and issuance (by registered mail with return receipt requested, or in the form of an electronic document signed with the electronic signature of the head of the Testing Organization or a person authorized by the head of the Testing Organization and meeting the requirements of paragraph 54 of the Rules, by sending it to the Applicant's email address specified in the application for conducting technical tests of the medical device) to the Applicant of the Protocol of Technical Tests of the Medical Device.
12. During the technical tests, the following is determined:
    a) Compliance of the medical device together with the accessories, special equipment and/or software, test databases (if available) specified in paragraph 8 of this Procedure with the requirements of applicable documents of the national standardization system, as well as the regulatory documentation, technical and operational documentation of the manufacturer for the medical device;
    b) Completeness and sufficiency of the characteristics established in the regulatory documentation, technical and operational documentation of the manufacturer for the medical device, subject to control during technical tests, as well as test methods;
    c) Quality of the medical device and safety of its use;
    d) The ability of the special equipment and/or software, test databases specified in subparagraphs "b" and "c" of paragraph 8 of this Procedure, developed by the manufacturer for technical tests of a specific medical device and specified by it in the technical documentation, to ensure the conduct of technical tests (as applicable).
13. The results of technical tests are considered negative if at least one of the following conditions is not met:
    a) The submitted medical device together with the accessories, special equipment and/or software, test databases (if available) specified in paragraph 8 of this Procedure complies with the requirements of applicable documents of the national standardization system, as well as the regulatory documentation, technical and operational documentation of the manufacturer for the medical device;
    b) The regulatory documentation, technical and operational documentation of the manufacturer for the medical device confirm the completeness and sufficiency of the characteristics of the medical device established therein, subject to control during technical tests, as well as the test methods;
    c) The quality of the medical device and the safety of its use are confirmed during the technical tests;
    d) The special equipment and/or software, test databases specified in subparagraphs "b" and "c" of paragraph 8 of this Procedure, developed by the manufacturer for technical tests of a specific medical device and specified by it in the technical documentation, ensure the possibility of conducting technical tests (as applicable).

III. Conformity Assessment of Medical Devices for In Vitro Diagnostics in the Form of Technical Tests

14. To conduct technical tests of medical devices for in vitro diagnostics, the Applicant or a person authorized by the Applicant submits to the Testing Organization (directly to the Testing Organization, or by registered mail with return receipt requested, or in the form of an electronic document signed with the electronic signature of the Applicant, by sending it to the Testing Organization's email address) an application for conducting technical tests of the medical device for in vitro diagnostics, specifying the information provided for in subparagraphs "a" - "l", "s" - "u", "x" (as applicable), "ts" and "ch" of paragraph 64 of the Rules, along with the documents specified in subparagraphs "a" - "d", "k" - "m" and "o" of paragraph 65 of the Rules, as well as a copy of the document confirming the authority to submit such an application on behalf of the Applicant (in case the application for conducting technical tests is submitted by a person authorized by the Applicant).

If the documents for the medical device for in vitro diagnostics specified in this paragraph are drawn up in a foreign language, they are submitted with a certified translation into Russian.

15. The Testing Organization reviews the application for conducting technical tests of medical devices for in vitro diagnostics and the documents specified in paragraph 14 of this Procedure within a period not exceeding 10 working days from the date of their receipt and decides on the possibility (impossibility) of conducting technical tests of medical devices for in vitro diagnostics.

If the Testing Organization decides on the possibility of conducting technical tests of the medical device for in vitro diagnostics, the Testing Organization notifies the Applicant in writing (sending a notification by registered mail with return receipt requested, or in the form of an electronic document signed with the electronic signature of the head of the Testing Organization or a person authorized by the head of the Testing Organization, by sending it to the Applicant's email address specified in the application for conducting technical tests of the medical device for in vitro diagnostics) within three working days from the date of such decision. Thereafter, jointly with the Applicant, it draws up a test program, which is approved by the head of the Testing Organization, and sends the Applicant a draft contract for conducting such tests.

16. If a decision is made on the impossibility of conducting technical tests of medical devices for in vitro diagnostics due to the lack of grounds for conducting technical tests (lack of accreditation) and/or the technical capability of the Testing Organization (malfunction or scheduled maintenance of the Testing Organization's equipment), or non-compliance of the submitted application for conducting technical tests of medical devices for in vitro diagnostics and the documents specified in paragraph 14 of this Procedure with the requirements of this Procedure, the Testing Organization notifies the Applicant in writing thereof (sending a notification by registered mail with return receipt requested, or in the form of an electronic document signed with the electronic signature of the head of the Testing Organization or a person authorized by the head of the Testing Organization, by sending it to the Applicant's email address specified in the application for conducting technical tests of medical devices for in vitro diagnostics) within three working days from the date of such decision, stating the reasons for refusing to conduct technical tests of medical devices for in vitro diagnostics.
17. After the approval of the test program by the head of the Testing Organization, as well as the signing of the contract for conducting technical tests of medical devices for in vitro diagnostics, the Applicant submits to the Testing Organization:
    a) The medical device for in vitro diagnostics together with accessories (in quantities according to the requirements of the national standardization system documents and the approved test program);
    b) Special equipment for testing or ensuring the functioning of the medical device for in vitro diagnostics, specified in the technical documentation of the manufacturer for the medical device for in vitro diagnostics (if available).
18. Technical tests of medical devices for in vitro diagnostics are conducted by the Testing Organization within a period not exceeding 30 working days from the date the Applicant provides the Testing Organization with the medical device for in vitro diagnostics, accessories, and special equipment (if available) specified in paragraph 17 of this Procedure, provided that the Applicant pays for the Testing Organization's services in accordance with the concluded contract. In cases where a longer period is provided for by the method of technical tests of medical devices for in vitro diagnostics, the period for conducting technical tests of medical devices for in vitro diagnostics is extended by decision of the head of the Testing Organization or a person authorized by the head of the Testing Organization for no more than 20 working days, and the Testing Organization notifies the Applicant thereof (by registered mail with return receipt requested, or in the form of an electronic document signed with the electronic signature of the head of the Testing Organization or a person authorized by the head of the Testing Organization, by sending it to the Applicant's email address specified in the application for conducting technical tests of medical devices for in vitro diagnostics) within three working days from the date of such decision.
19. When conducting technical tests of a medical device for in vitro diagnostics, the following is carried out:
    a) Assessment of the compliance of the characteristics (properties) of the medical device for in vitro diagnostics with the requirements of regulatory documentation, technical and operational documentation of the manufacturer for the medical device for in vitro diagnostics;
    b) Determination of the potential risk class of using the medical device for in vitro diagnostics in accordance with the nomenclature classification of medical devices;
    c) Assessment of the completeness and sufficiency of the information contained in the application for conducting technical tests of the medical device for in vitro diagnostics and the documents specified in paragraph 14 of this Procedure;
    d) Preparation and issuance (by registered mail with return receipt requested, or in the form of an electronic document signed with the electronic signature of the head of the Testing Organization or a person authorized by the head of the Testing Organization and meeting the requirements of paragraph 54 of the Rules, by sending it to the Applicant's email address specified in the application for conducting technical tests of the medical device for in vitro diagnostics) to the Applicant of the Protocol of Technical Tests of the Medical Device for In Vitro Diagnostics.
20. During the technical tests of a medical device for in vitro diagnostics in accordance with the approved test program specified in paragraph 17 of this Procedure, the following is determined:
    a) Compliance of the medical device for in vitro diagnostics with the requirements of applicable documents of the national standardization system, as well as the requirements established in the regulatory documentation, technical and operational documentation of the manufacturer for the medical device for in vitro diagnostics;
    b) Compliance of the technical and operational documentation of the manufacturer for the medical device for in vitro diagnostics submitted by the Applicant with the requirements of applicable documents of the national standardization system and regulatory documentation for the medical device for in vitro diagnostics;
    c) Completeness and sufficiency of the functional characteristics established in the regulatory documentation, technical and operational documentation of the manufacturer for the medical device for in vitro diagnostics, subject to control during technical tests of the medical device for in vitro diagnostics, as well as test methods;
    d) Quality of the medical device for in vitro diagnostics and safety of its use;
    e) The ability of the special equipment for testing or ensuring the functioning of the medical device for in vitro diagnostics, specified in the technical documentation of the manufacturer for the medical device for in vitro diagnostics, to ensure the conduct of technical tests of the medical device for in vitro diagnostics (as applicable).
21. The results of technical tests of a medical device for in vitro diagnostics are considered negative if at least one of the following conditions is not met:
    a) The submitted medical device for in vitro diagnostics complies with the requirements of applicable documents of the national standardization system, as well as the requirements established in the regulatory documentation, technical and operational documentation of the manufacturer for the medical device for in vitro diagnostics;
    b) The technical and operational documentation of the manufacturer for the medical device for in vitro diagnostics submitted by the Applicant complies with the requirements of applicable documents of the national standardization system and regulatory documentation for the medical device for in vitro diagnostics;
    c) The regulatory documentation, technical and operational documentation of the manufacturer for the medical device for in vitro diagnostics confirm the completeness and sufficiency of the functional characteristics established therein, subject to control during technical tests of the medical device for in vitro diagnostics, as well as test methods;
    d) The quality of the medical device for in vitro diagnostics and the safety of its use are confirmed during the technical tests of the medical device for in vitro diagnostics;
    e) The special equipment for testing or ensuring the functioning of the medical device for in vitro diagnostics, specified in the technical documentation of the manufacturer for the medical device for in vitro diagnostics, ensures the possibility of conducting technical tests of the medical device for in vitro diagnostics (as applicable).

IV. Conformity Assessment of Medical Devices in the Form of Toxicological Studies

22. Toxicological studies are conducted in relation to medical devices and/or accessories that directly or indirectly contact the surface of the human body, its mucous membranes, internal environments of the body, for which such interaction (contact) is necessary for the performance of their intended functions, and include:
    a) Determination of sanitary-chemical indicators;
    b) Assessment of biological indicators in in vitro and in vivo conditions. The types of biological effects are subject to assessment based on the type and duration of contact of the medical device with the human body;
    c) Microbiological tests (studies).
23. To conduct toxicological studies, the Applicant or a person authorized by the Applicant submits to the Testing Organization (directly to the Testing Organization, or by registered mail with return receipt requested, or in the form of an electronic document signed with the electronic signature of the Applicant, by sending it to the Testing Organization's email address) an application for conducting toxicological studies, specifying the information provided for in subparagraphs "a" - "l", "s" - "u" and "x" (as applicable), "ts" and "ch" of paragraph 64 of the Rules, along with the documents specified in subparagraphs "a" - "d", "k" - "m" and "o" of paragraph 65 of the Rules, as well as a copy of the document confirming the authority to submit such an application on behalf of the Applicant (in case the application for conducting toxicological studies is submitted by a person authorized by the Applicant).

If the documents for the medical device specified in this paragraph are drawn up in a foreign language, they are submitted with a certified translation into Russian.

24. The Testing Organization reviews the application for conducting toxicological studies and the documents specified in paragraph 23 of this Procedure within a period not exceeding 10 working days from the date of their receipt and decides on the possibility (impossibility) of conducting toxicological studies.

If the Testing Organization decides on the possibility of conducting toxicological studies, the Testing Organization notifies the Applicant in writing (sending a notification by registered mail with return receipt requested, or in the form of an electronic document signed with the electronic signature of the head of the Testing Organization or a person authorized by the head of the Testing Organization, by sending it to the Applicant's email address specified in the application for conducting toxicological studies) within three working days from the date of such decision. Thereafter, jointly with the Applicant, it draws up a study program, which is approved by the head of the Testing Organization, and sends the Applicant a draft contract for conducting such studies.

25. After the approval of the study program by the head of the Testing Organization, as well as the signing of the contract for conducting toxicological studies, the Applicant submits the medical device and accessories to the Testing Organization.
26. Toxicological studies are conducted by the Testing Organization within a period not exceeding 30 working days from the date the Applicant provides the Testing Organization with the medical device and accessories, provided that the Applicant pays for the Testing Organization's services in accordance with the concluded contract.

In cases where a longer period is provided for by the method of toxicological studies, the period for conducting toxicological studies is extended by decision of the head of the Testing Organization for no more than 20 working days, and the Testing Organization notifies the Applicant thereof (by registered mail with return receipt requested, or in the form of an electronic document signed with the electronic signature of the head of the Testing Organization or a person authorized by the head of the Testing Organization, by sending it to the Applicant's email address specified in the application for conducting toxicological studies) within three working days from the date of such decision.

27. When conducting toxicological studies in accordance with the approved study program specified in paragraph 25 of this Procedure, the following is carried out:
    a) Assessment of the compliance of the medical device and accessories with the data of regulatory documentation, technical and operational documentation of the manufacturer for the medical device;
    b) Determination of the potential risk class of using the medical device in accordance with the nomenclature classification of medical devices;
    c) Determination of the duration of contact of the medical device and/or material with the human body;
    d) Assessment of the completeness and sufficiency of the information contained in the application for conducting toxicological studies and the documents specified in paragraph 23 of this Procedure;
    e) Preparation and issuance (by registered mail with return receipt requested, or in the form of an electronic document signed with the electronic signature of the head of the Testing Organization or a person authorized by the head of the Testing Organization and meeting the requirements of paragraph 54 of the Rules, by sending it to the Applicant's email address specified in the application for conducting technical tests) to the Applicant of the Protocol of Toxicological Studies.
28. During the toxicological studies, the following is determined:
    a) Compliance of the medical device and accessories with the requirements of applicable documents of the national standardization system, regulatory documentation, technical and operational documentation of the manufacturer for the medical device;
    b) Compliance of the technical and operational documentation of the manufacturer for the medical device submitted by the Applicant with the requirements of applicable documents of the national standardization system and regulatory documentation for the medical device;
    c) Completeness and sufficiency of the characteristics established by the regulatory documentation, technical and operational documentation of the manufacturer for the medical device, subject to control during toxicological studies, as well as study methods;
    d) Safety of using the medical device and/or accessories, and/or materials.
29. The results of toxicological studies are considered negative if at least one of the following conditions is not met:
    a) The medical device and/or accessories comply with the requirements of applicable documents of the national standardization system, regulatory documentation, technical and operational documentation of the manufacturer for the medical device;
    b) The technical and operational documentation of the manufacturer for the medical device submitted by the Applicant complies with the requirements of applicable documents of the national standardization system and regulatory documentation for the medical device;
    c) The regulatory documentation, technical and operational documentation of the manufacturer for the medical device confirm the completeness and sufficiency of the characteristics established therein, subject to control during toxicological studies, as well as study methods;
    d) The safety of using the medical device and/or accessories, and/or materials is confirmed during the toxicological studies.

V. Conformity Assessment of a Medical Device in the Form of Clinical Trials (Except for Medical Devices for In Vitro Diagnostics)

30. Clinical trials are conducted in the form of studies, including through the analysis and evaluation of clinical data (hereinafter referred to as Analysis and Evaluation of Clinical Data), and/or in the form of trials involving humans (hereinafter referred to as Clinical Trials Involving Humans), carried out to assess the safety and effectiveness of the medical device.
31. Clinical trials involving humans are conducted in the following cases:
    a) New type of medical device;
    b) Use of new complex and/or unique and/or special methods of prevention, diagnosis, and treatment of diseases and conditions, as well as the use of new complex technologies;
    c) Changes in the design of the medical device affecting its functional purpose and/or operating principle;
    d) Expansion of the list of indications for use of the medical device or change in the purpose of use of the medical device;
    e) The effectiveness and safety of the medical device are not confirmed during the analysis and evaluation of clinical data;
    f) For medical devices containing new materials contacting the human body, previously unstudied in terms of biological action, or known materials contacting those organs or tissues of humans for which there is no experience of their medical use, or if such contact is longer than previously studied.

In other cases, clinical trials are conducted through analysis and evaluation of clinical data.

32. To conduct clinical trials, the Applicant or a person authorized by the Applicant submits to the Medical Organization:
    a) An application for conducting clinical trials, specifying the information provided for in subparagraphs "a" - "o", "r" - "u", "x" (as applicable), "ts" and "ch" of paragraph 64 of the Rules, along with the documents specified in subparagraphs "a" - "d", "k" - "m" and "o" of paragraph 65 of the Rules;
    b) Documents (information) containing data on the clinical use of the medical device, including outside the Russian Federation, including reviews, reports on scientific studies conducted in public medical institutions, publications, reports, risk analysis of use, methods of using the medical device (if available);
    c) Permission to conduct clinical trials issued by the Federal Service for Surveillance in Healthcare (hereinafter referred to as the Registering Authority) (except for medical devices specified in paragraph 24 of the Rules, medical devices that have undergone state registration in accordance with the specifics of circulation of medical devices, including state registration of a series (batch) of a medical device, approved by Decree of the Government of the Russian Federation No. 430 dated April 3, 2020, which are valid until January 1, 2028, or the specifics of circulation, including the specifics of state registration, of medical devices in case of their shortage or risk of shortage due to the introduction of economic restrictive measures against the Russian Federation, approved by Decree of the Government of the Russian Federation No. 552 dated April 1, 2022, which are valid until January 1, 2028, medical devices for in vitro diagnostics, software that is a medical device, and also except for cases of conducting clinical trials for the purpose of amending documents contained in the registration dossier for a medical device) (in the case of conducting clinical trials involving humans).

If the documents for the medical device specified in this paragraph are drawn up in a foreign language, they are submitted with a certified translation into Russian.

33. The Medical Organization reviews the application for conducting clinical trials and the documents specified in paragraph 32 of this Procedure within a period not exceeding 10 working days from the date of their receipt and decides on the possibility (impossibility) of conducting clinical trials.
34. If a decision is made on the possibility of conducting clinical trials, the Medical Organization notifies the Applicant in writing (sending a notification by registered mail with return receipt requested, or in the form of an electronic document signed with the electronic signature of the head of the Testing Organization or a person authorized by the head of the Testing Organization, by sending it to the Applicant's email address specified in the application for conducting toxicological studies) within three working days from the date of such decision. Thereafter, taking into account the purpose and complexity of the medical device, it determines the duration of the clinical trials, concludes a contract with the Applicant for conducting such trials, and jointly with the Applicant draws up a clinical trial program, which is approved by the head of the Medical Organization or a person authorized by the head of the Medical Organization.

In case of a decision on the impossibility of conducting clinical trials due to the lack of grounds for conducting clinical trials (absence in the license for medical activities of the works (services) constituting medical activity, based on the purpose and scope of application of the medical device), or non-compliance of the submitted application for conducting clinical trials and the documents specified in paragraph 32 of this Procedure with the requirements of this Procedure, the Medical Organization notifies the Applicant in writing thereof (sending a notification by registered mail with return receipt requested, or in the form of an electronic document signed with the electronic signature of the head of the Medical Organization or a person authorized by the head of the Medical Organization, to the Applicant's email address specified in the application for conducting clinical trials) within three working days from the date of such decision, stating the reasons for refusing to conduct clinical trials.

After signing the contract for conducting clinical trials, the Applicant submits the medical device together with the accessories to the Medical Organization (in the quantity provided for by the draft clinical trial program).

For medical devices whose clinical trials or installation (commissioning) require permits (including licenses), major repairs, construction of individual capital structures, clinical trials may be conducted on the premises of the manufacturer or in an organization where the medical device is located and/or permitted for use in accordance with the legislation of that country.

35. The clinical trial program includes:
    a) Name of the medical device (indicating the models (modifications) of the medical device, their composition and accessories (if available), while the Applicant indicates the trademark and other means of individualization of the medical device if they are affixed to the packaging of the medical device);
    b) Type(s) of medical device in accordance with the nomenclature classification of medical devices;
    c) Potential risk class of using the medical device in accordance with the nomenclature classification of medical devices;
    d) Information about the manufacturer or authorized representative of the manufacturer:

legal entity: full and abbreviated (if available) name (with transliteration), legal form, taxpayer identification number (for manufacturers resident in the Russian Federation), location address, as well as telephone number and email address;

individual registered as an individual entrepreneur: last name, first name, patronymic (if available), type and details of identity document, taxpayer identification number (for manufacturers resident in the Russian Federation), residential address, as well as telephone number and email address (if available);
e) Address(es) of the production site(s) location;
f) Grounds for conducting clinical trials;
g) Purpose of conducting clinical trials;
h) List of regulatory legal acts in accordance with which clinical trials are conducted;
i) Tasks of clinical trials;
j) Information about the Medical Organization:

full name;

address within the location;

details of the license for medical activities, validity period of such license;
k) Planned period for conducting clinical trials;
l) Information about the medical device provided for clinical trials:

quantity;

batch number or serial numbers of the medical device;

date of manufacture of the medical device;

expiry date or service life of the medical device (if any);
m) List of documents submitted for clinical trials;
n) Brief description of the medical device (appearance, purpose);
o) Form of clinical trials;
p) Plan of clinical trials;
q) Staging of clinical trials;
r) Documenting of the results of clinical trials.

36. The clinical trial program, approved by the head of the Medical Organization or a person authorized by the head of the Medical Organization conducting the clinical trials, together with the documents specified in paragraph 32 of this Procedure, in the case of conducting clinical trials involving humans, is sent by the Applicant to the Ethics Council in the Sphere of Circulation of Medical Devices of the Ministry of Health of the Russian Federation (hereinafter referred to as the Ethics Council).

Within a period not exceeding 30 working days from the date of receipt of documents for review, the Ethics Council issues a conclusion on the ethical justification for conducting clinical trials of the medical device.

37. Conducting clinical trials involving humans is carried out based on the conclusion on the ethical justification of the possibility of conducting clinical trials of medical devices involving humans as subjects.

In the event of a medical device failure or a deterioration in the patient's condition during clinical trials, the head of the medical organization or a person authorized by the head of the medical organization conducting the clinical trials shall suspend or terminate such trials, notifying the applicant with a justification for the reasons for the suspension or termination.

38. Conducting clinical trials of software that is a medical device and/or software using artificial intelligence technologies that is a medical device is carried out using patient medical data verified by the Medical Organization, obtained during diagnosis, treatment, rehabilitation, or patient data obtained during clinical trials involving humans (as applicable).
39. When conducting clinical trials, including clinical trials involving humans, the following is carried out:
    a) Assessment of the completeness and sufficiency of the information contained in the application for conducting clinical trials and the documents submitted by the Applicant in accordance with paragraph 32 of this Procedure;
    b) Assessment of information about clinically significant corrective actions taken, including the suspension of use of the medical device, withdrawal of the medical device from circulation, recalls of the medical device;
    c) Analysis of scientific literature and/or published studies (scientific articles, monographs, dissertations in the field of medical use of the medical device), correlated with the intended use of the tested medical device by the manufacturer and the proposed method of its use;
    d) Assessment of the reliability of the clinical connection, analytical and clinical validation of software using artificial intelligence technologies that is a medical device;
    e) Analysis of the effectiveness, safety, and quality of use of artificial intelligence systems of software using artificial intelligence technologies that is a medical device;
    f) Revision of regulatory documentation, technical and operational documentation of the manufacturer for the medical device based on the results of clinical trials (if necessary);
    g) Analysis and evaluation of information about interchangeable medical devices;
    h) Preparation and issuance (by registered mail with return receipt requested, or in the form of an electronic document signed with the electronic signature of the head of the Medical Organization or a person authorized by the head of the Medical Organization and meeting the requirements of paragraph 54 of the Rules, by sending it to the Applicant's email address specified in the application for conducting clinical trials) to the Applicant of the Report on the Evaluation of the Results of Clinical Trials of the Medical Device, indicating the date and number of the report;
    i) Entry of information about the conducted clinical trials, including information about the issued Report on the Evaluation of the Results of Clinical Trials of the Medical Device, into the automated information system of the Registering Authority.
40. During the clinical trials, the following is determined:
    a) Compliance of the medical device with the regulatory documentation, technical and operational documentation of the manufacturer for the medical device;
    b) Compliance of the regulatory documentation, technical and operational documentation of the manufacturer for the medical device submitted by the Applicant with the purpose and indications for use of the medical device established by the manufacturer;
    c) Completeness and reliability of the characteristics of the medical device established by the regulatory documentation, technical and operational documentation of the manufacturer for the medical device;
    d) Quality of the medical device, effectiveness and safety of its use.
41. The results of clinical trials of a medical device are considered negative if at least one of the following conditions is not met:
    a) The medical device complies with the regulatory documentation, technical and operational documentation of the manufacturer for the medical device;
    b) The regulatory documentation, technical and operational documentation of the manufacturer for the medical device submitted by the Applicant complies with the purpose and indications for use of the medical device established by the manufacturer;
    c) The regulatory documentation, technical and operational documentation of the manufacturer for the medical device confirm the completeness and reliability of the characteristics of the medical device established therein;
    d) The quality of the medical device, effectiveness and safety of its use are confirmed during the clinical trials of the medical device.

VI. Conformity Assessment of Medical Devices for In Vitro Diagnostics in the Form of Clinical Trials

42. Clinical trials of medical devices for in vitro diagnostics are conducted in laboratory conditions using patient biomaterial samples taken during the diagnostic and treatment process on the territory of the Russian Federation from a reference population, including residual samples, archival samples, or purposefully selected samples (hereinafter referred to as Clinical-Laboratory Trials) to verify the functional characteristics and/or effectiveness of the medical device when used in accordance with its intended purpose, as provided for by the regulatory documentation, technical and operational documentation of the manufacturer for the medical device for in vitro diagnostics.

Clinical-laboratory trials of a medical device for in vitro diagnostics for new infectious diseases or rare natural-focal infectious diseases are conducted in laboratory conditions using museum test strains from state, national, research, and other collections of pathogenic microorganisms and/or samples obtained by genetic engineering methods.

Clinical-laboratory trials of a medical device for in vitro diagnostics for especially dangerous infections are carried out by a Medical Organization authorized to work with microorganisms of I - II pathogenicity groups.

Clinical-laboratory trials of medical devices for in vitro diagnostics in the form of analytical systems, conducted in relation to the medical device, together with accessories, reagent kits, and calibrators necessary for the intended use of the medical device, are carried out within a single trial.

43. To conduct clinical-laboratory trials, the Applicant submits to the Medical Organization an application for conducting clinical-laboratory trials, specifying the information provided for in subparagraphs "a" - "o", "r" - "u", "x" (as applicable), "ts" and "ch" of paragraph 64 of the Rules, along with the documents specified in subparagraphs "a" - "d", "k" - "m" and "o" of paragraph 65 of the Rules.

If the documents for the medical device for in vitro diagnostics specified in this paragraph are drawn up in a foreign language, they are submitted with a certified translation into Russian.

44. The Medical Organization conducting the clinical-laboratory trials reviews the application for conducting clinical-laboratory trials and the documents specified in paragraph 43 of this Procedure within a period not exceeding 10 working days from the date of their receipt and decides on the possibility (impossibility) of conducting clinical-laboratory trials.
45. In case of a decision on the possibility of conducting clinical-laboratory trials, the Medical Organization notifies the Applicant in writing (sending a notification by registered mail with return receipt requested, or in the form of an electronic document signed with the electronic signature of the head of the Testing Organization or a person authorized by the head of the Testing Organization, by sending it to the Applicant's email address specified in the application for conducting clinical-laboratory trials) within three working days from the date of such decision. Thereafter, taking into account the purpose and complexity of the medical device for in vitro diagnostics, it determines the duration of the clinical-laboratory trials, draws up a draft program of clinical-laboratory trials, approved by the head of the organization or a person authorized by the head of the organization, and concludes a contract with the Applicant for conducting such trials.

In case of a decision on the impossibility of conducting clinical-laboratory trials due to the lack of grounds for conducting clinical-laboratory trials (lack of accreditation or absence in the license for medical activities of the works (services) constituting medical activity, based on the purpose and scope of application of the medical device for in vitro diagnostics), or non-compliance of the submitted application for conducting clinical-laboratory trials and the documents specified in paragraph 43 of this Procedure with the requirements of this Procedure, the Medical Organization notifies the Applicant in writing thereof (sending a notification by registered mail with return receipt requested, or in the form of an electronic document signed with the electronic signature of the head of the Medical Organization or a person authorized by the head of the Medical Organization, to the Applicant's email address specified in the application for conducting clinical-laboratory trials) within three working days from the date of such decision, stating the reasons for refusing to conduct clinical-laboratory trials.

After signing the contract for conducting clinical-laboratory trials, the Applicant submits the medical device for in vitro diagnostics together with the accessories to the Medical Organization (in the quantity provided for by the draft program of clinical-laboratory trials).

46. The program of clinical-laboratory trials includes:
    a) Name of the medical device (indicating the models (modifications) of the medical device, their composition and accessories (if available), while the Applicant indicates the trademark and other means of individualization of the medical device if they are affixed to the packaging of the medical device);
    b) Type(s) of medical device for in vitro diagnostics in accordance with the nomenclature classification of medical devices;
    c) Potential risk class of using the medical device for in vitro diagnostics in accordance with the nomenclature classification of medical devices;
    d) Information about the manufacturer or authorized representative of the manufacturer for in vitro diagnostics:
• legal entity: full and abbreviated (if available) name (with transliteration), legal form, taxpayer identification number (for manufacturers resident in the Russian Federation), location address, as well as telephone number and email address;
• individual registered as an individual entrepreneur: last name, first name, patronymic (if available), type and details of identity document, taxpayer identification number (for manufacturers resident in the Russian Federation), residential address (stay), as well as telephone number and email address (if available);
  e) Address(es) of the production site(s) location;
  f) Grounds for conducting clinical-laboratory trials;
  g) Purpose of conducting clinical-laboratory trials;
  h) List of regulatory legal acts in accordance with which clinical-laboratory trials are conducted;
  i) Information about the Medical Organization:
• full name;
• details of the license for medical activities, validity period of such license (if available);
• place(s) of measurements (analysis) conducted as part of the clinical-laboratory trials (if different from the location address of the Medical Organization);
  j) Information about the medical device for in vitro diagnostics provided for clinical-laboratory trials:
• quantity;
• batch number or serial numbers of the medical device for in vitro diagnostics;
• date of manufacture of the medical device for in vitro diagnostics;
• expiry date or service life of the medical device for in vitro diagnostics (if any);
  k) List of documents submitted for clinical-laboratory trials;
  l) Brief description of the medical device for in vitro diagnostics (appearance, purpose);
  m) Technical characteristics of the medical device for in vitro diagnostics;
  n) Indications and contraindications for the use of the medical device, including information on possible complications of the patient's disease when using the medical device for in vitro diagnostics;
  o) Form of clinical-laboratory trials;
  p) Plan of clinical-laboratory trials;
  q) Methodology of clinical-laboratory trials;
  r) Documenting of the conclusions of the results of clinical-laboratory trials.
47. When conducting clinical-laboratory trials, the following is carried out:
    a) Assessment of the completeness and sufficiency of the information contained in the application for conducting clinical-laboratory trials and the documents submitted by the Applicant in accordance with paragraph 43 of this Procedure;
    b) Assessment and analysis of data on the functional characteristics of the medical device for in vitro diagnostics obtained during clinical-laboratory trials for compliance with the characteristics established by the regulatory documentation, technical and operational documentation of the manufacturer for the medical device for in vitro diagnostics;
    c) Revision of regulatory documentation, technical and operational documentation of the manufacturer for the medical device for in vitro diagnostics based on the results of clinical-laboratory trials (if necessary);
    d) Preparation and issuance (by registered mail with return receipt requested, or in the form of an electronic document signed with the electronic signature of the head of the Medical Organization or a person authorized by the head of the Medical Organization and meeting the requirements of paragraph 54 of the Rules, by sending it to the Applicant's email address specified in the application for conducting clinical-laboratory trials) to the Applicant of the Report on the Evaluation of the Results of Clinical-Laboratory Trials;
    e) Entry of information about the conducted clinical-laboratory trials, including information about the issued Report on the Evaluation of the Results of Clinical-Laboratory Trials of the Medical Device for In Vitro Diagnostics, into the automated information system of the Registering Authority.
48. During the clinical-laboratory trials, the following is determined:
    a) Compliance of the medical device for in vitro diagnostics with the regulatory documentation, technical and operational documentation of the manufacturer for the medical device for in vitro diagnostics;
    b) Compliance of the medical device for in vitro diagnostics with the intended use by the manufacturer and the proposed methods of use;
    c) Completeness and reliability of the safety and effectiveness characteristics of the medical device for in vitro diagnostics established by the regulatory documentation, technical and operational documentation of the manufacturer for the medical device for in vitro diagnostics in accordance with the intended use of the medical device for in vitro diagnostics by the manufacturer, including its diagnostic sensitivity, specificity, and reproducibility, as well as functional characteristics (including, as applicable, analytical sensitivity, specificity, reproducibility, linearity) specified in the regulatory documentation, technical and operational documentation of the manufacturer for the medical device for in vitro diagnostics;
    d) Quality of the medical device for in vitro diagnostics, effectiveness and safety of its use.
49. The results of clinical-laboratory trials are considered negative if at least one of the following conditions is not met:
    a) The medical device for in vitro diagnostics complies with the regulatory documentation, technical and operational documentation of the manufacturer for the medical device for in vitro diagnostics;
    b) The medical device for in vitro diagnostics complies with the intended use by the manufacturer and the proposed methods of use;
    c) The regulatory documentation, technical and operational documentation of the manufacturer (producer) of the medical device for in vitro diagnostics for the medical device for in vitro diagnostics confirms the completeness and reliability of the safety and effectiveness characteristics of the medical device for in vitro diagnostics established therein in accordance with the intended use of the medical device for in vitro diagnostics by the manufacturer (producer) of the medical device for in vitro diagnostics, including its diagnostic sensitivity, specificity and reproducibility, as well as functional characteristics (including, by applicability, analytical sensitivity, specificity, reproducibility, linearity);
    
    d) The quality, effectiveness, and safety of the medical device for in vitro diagnostics are confirmed during the trials.

Appendix No. 1

to the Procedure for Conducting Conformity Assessment in the Form of Technical Tests, Toxicological Studies, Clinical Trials of Medical Devices for the Purpose of State Registration of Medical Devices, approved by Order of the Ministry of Health of the Russian Federation No. 421n dated May 13, 2026

Recommended Template

[Letterhead of the Testing Organization: name, address, phone number, email, website, unique accreditation entry number]

APPROVED BY
Head or other authorized person of the Testing Organization
Last name, first name, patronymic (if available), signature, seal (if available)
"_" _______ 20

PROTOCOL OF TECHNICAL TESTS No. ___

of a medical device or a medical device for in vitro diagnostics

Full name, location address, phone number, email of the manufacturer or authorized representative of the manufacturer: ________________________

Name of medical device: ________________________
Model (modification) of medical device: ________________________

Date of submission of the medical device to the testing laboratory (center) accredited in the national accreditation system (hereinafter - Testing Organization) for technical testing: ________________________
Date of receipt of the medical device by the Testing Organization: ________________________
Period of technical tests: ________________________
Address of technical tests: ________________________

Verification of the medical device for compliance with the requirements of applicable documents of the national standardization system and technical documentation of the manufacturer: ________________________

Conclusion on compliance of the medical device with the requirements of applicable documents of the national standardization system and technical documentation of the manufacturer: ________________________

Additional information: ________________________

1. General data: ________________________
(test object, manufacturer, manufacturer's address, name(s) (with transliteration) of production site(s), address(es) of its(their) location, address of receipt of the medical device, name of the medical device submitted for technical tests)

2. Brief description, purpose, scope and main characteristics of the medical device: ________________________

3. List of documents submitted for technical tests: ________________________

4. Procedure of technical tests: ________________________
(conditions for conducting technical tests)

5. Methods of technical tests: ________________________

6. Information about the person authorized by the head of the Testing Organization who conducted the technical tests: ________________________
(last name, first name, patronymic (if available), position)

7. Measuring instruments, test equipment, auxiliary equipment and materials used for conducting technical tests: ________________________
(name, serial number)

8. Results of technical tests: ________________________
(information on regulatory technical requirements (section of applicable documents of the national standardization system and technical documentation), test results, conclusions)

9. Conclusions: ________________________
(compliance with the requirements of applicable documents of national standardization, regulatory documentation, technical and operational documentation of the manufacturer)

Appendices: ________________________

Signatures:

Head of the structural unit of the Testing Organization
________________________ (last name, first name, patronymic (if available), signature)

Person authorized by the head of the Testing Organization responsible for preparing the protocol
________________________ (last name, first name, patronymic (if available), signature)

Appendix No. 2

to the Procedure for Conducting Conformity Assessment in the Form of Technical Tests, Toxicological Studies, Clinical Trials of Medical Devices for the Purpose of State Registration of Medical Devices, approved by Order of the Ministry of Health of the Russian Federation No. 421n dated May 13, 2026

Recommended Template

[Letterhead of the Testing Organization: name, address, phone number, email, website, unique accreditation entry number]

APPROVED BY
Head or other authorized person of the Testing Organization
Last name, first name, patronymic (if available), signature, seal (if available)
"_" _______ 20

PROTOCOL OF TOXICOLOGICAL STUDIES No. ___

Full name, location address, phone number, email of the manufacturer or authorized representative of the manufacturer: ________________________

Name of medical device: ________________________
Model (modification) of medical device: ________________________

Date of submission of the medical device to the testing laboratory (center) accredited in the national accreditation system (hereinafter - Testing Organization) for toxicological studies: ________________________
Date of receipt of the medical device by the Testing Organization: ________________________
Period of toxicological studies: ________________________
Address for conducting toxicological studies: ________________________

Verification of the medical device for compliance with the requirements of applicable documents of the national standardization system and technical documentation of the manufacturer: ________________________

Conclusion on compliance of the medical device with the requirements of applicable documents of the national standardization system and technical documentation of the manufacturer: ________________________

Additional information: ________________________

1. General data: ________________________
(test object, manufacturer, manufacturer's address, name(s) (with transliteration) of production site(s), address(es) of its(their) location, address of receipt of the medical device, name of the medical device submitted for toxicological studies)

2. Brief description, purpose, scope of application and main characteristics of the medical device: ________________________

3. List of documents submitted for toxicological studies: ________________________

4. Procedure of toxicological studies: ________________________
(conditions for conducting toxicological studies)

5. Methods of toxicological studies: ________________________

6. Information about the person authorized by the head of the Testing Organization who conducted the toxicological studies: ________________________
(last name, first name, patronymic (if available), position)

7. Measuring instruments, test equipment, auxiliary equipment and materials used for conducting toxicological studies: ________________________
(name, serial number)

8. Results of toxicological studies: ________________________
(information on regulatory technical requirements (section of applicable documents of the national standardization system and technical documentation), test results, conclusions)

9. Conclusions: ________________________
(compliance with the requirements of applicable documents of national standardization, regulatory documentation, technical and operational documentation of the manufacturer)

Appendices: ________________________

Signatures:

Head of the structural unit of the Testing Organization
________________________ (last name, first name, patronymic (if available), signature)

Person authorized by the head of the Testing Organization responsible for preparing the protocol
________________________ (last name, first name, patronymic (if available), signature)

Appendix No. 3

to the Procedure for Conducting Conformity Assessment in the Form of Technical Tests, Toxicological Studies, Clinical Trials of Medical Devices for the Purpose of State Registration of Medical Devices, approved by Order of the Ministry of Health of the Russian Federation No. 421n dated May 13, 2026

Recommended Template

[Letterhead of the Medical Organization: name, address, phone number]

APPROVED BY
Head or other authorized person of the Medical Organization
Last name, first name, patronymic (if available), signature, seal (if available)
"_" _______ 20

REPORT No. ___
on the Evaluation of the Results of Clinical Trials of a Medical Device
dated "_" _______ 20

(name of medical device)

Prepared by: ________________________
(name of medical organization, indicating the place of testing)

Authority to conduct testing work. License for medical activities No. ___ dated "_" _______ 20, valid until __________

1. During the period from "" _______ 20 to "" _______ 20,

___________________________________ (name of medical organization conducting clinical trials) conducted an evaluation of the results of clinical trials in the form of studies, including through the analysis and evaluation of clinical data (hereinafter - Analysis and Evaluation of Clinical Data), and in the form of trials involving humans (hereinafter - Clinical Trials Involving Humans)______________ (specify which is necessary)

___________________________________________________________________

(name of medical device (indicating accessories necessary for the use of the medical device or its models (modifications) as intended)) manufactured by ______________________ (name of manufacturer, country of manufacture) in accordance with ___________________(name and designation of technical and operational documentation).

2. For conducting clinical trials, the following were submitted:____________________-
   (list of documents, quantity of medical device)
3. (Name of medical organization) conducted an evaluation of the results of clinical trials of (name of medical device) in accordance with the approved clinical trial program:

3.1. Name of medical device (indicating models (modifications), their composition and accessories (if available), trademark and other means of individualization if affixed to the packaging): ________________________
3.2. Type(s) of medical device in accordance with the nomenclature classification of medical devices: ________________________
3.3. Potential risk class of using the medical device in accordance with the nomenclature classification of medical devices: ________________________
3.4. Information about the manufacturer or authorized representative of the manufacturer (legal entity or individual entrepreneur details): ________________________
3.5. Address(es) of production site(s): ________________________
3.6. Grounds for conducting clinical trials: ________________________
3.7. Purpose of clinical trials: ________________________
3.8. List of regulatory legal acts in accordance with which clinical trials are conducted: ________________________
3.9. Tasks of clinical trials: ________________________
3.10. Information about the Medical Organization (full name, address, license details): ________________________
3.11. Planned period of clinical trials: ________________________
3.12. Information about the medical device provided for clinical trials (quantity, batch/serial numbers, manufacture date, expiry/service life): ________________________
3.13. List of documents submitted for clinical trials: ________________________
3.14. Brief description of the medical device (appearance, purpose): ________________________
3.15. Form of clinical trials: ________________________
3.16. Plan of clinical trials: ________________________
3.17. Phasing of clinical trials: ________________________
3.18. Documentation of clinical trial results: ________________________

4. Characteristics of patients (number, gender, age, diagnosis), their informed consent: ________________________
5. information on interchangeable medical devices:________________
6. Runtime of the medical device in hours during clinical trials, number of measurements, sterilization cycles (if available): ________________________
7. Functional qualities of the medical device, effectiveness of its use, indications and contraindications for its use: ________________________
8. Capabilities of the medical device regarding accuracy of measurements, reliability, reproducibility, dependability: ________________________
9. Operational qualities of the medical device, controllability and ease of handling, technical aesthetics of the medical device, its design, resistance to disinfection, sterilization: ________________________
10. Information about defects in design and quality of the medical device discovered during clinical trials (if any), features of working with it during operation: ________________________
11. Results of conducted clinical trials of the medical device indicating the number of examinations, operations, procedures, analyses performed: ________________________
12. Summary of clinical trial results: ________________________
13. Conclusions based on clinical trial results: ________________________
14. Evaluation of clinical trial results:

CONCLUSION

_______________________(name of medical device) complies (does not comply) with the requirements of regulatory documentation, technical and operational documentation, and the purpose and indications for use established by the manufacturer. The quality, effectiveness, and safety of the medical device are confirmed (not confirmed).

Appendices:

1. Conclusion on the ethical justification for conducting clinical trials of the medical device (copy), issued by the Ethics Council in the Sphere of Circulation of Medical Devices of the Ministry of Health of the Russian Federation (in case of conducting clinical trials involving humans).
2. Approved program of clinical trials of the medical device.
3. Protocols of clinical trials or results of evaluation and analysis of data, including graphs, images, including from primary medical documentation, confirming clinical observation data, tabulated, statistically processed material.
4. Data on the use of medical devices in medical practice (if available).
5. Operational documentation of the manufacturer for the medical device (copy), in case of revision based on clinical trial results (including instructions for medical use or operator's manual). Appendices are an integral part of this Report.

Signatures:

Head of the structural unit of the Medical Organization
________________________ (position, last name, first name, patronymic (if available))

Person authorized by the head of the Medical Organization responsible for preparing the report
________________________ (position, last name, first name, patronymic (if available))

Appendix No. 4

to the Procedure for Conducting Conformity Assessment in the Form of Technical Tests, Toxicological Studies, Clinical Trials of Medical Devices for the Purpose of State Registration of Medical Devices, approved by Order of the Ministry of Health of the Russian Federation No. 421n dated May 13, 2026

Recommended Template

[Letterhead of the Medical Organization: name, address, phone number]

APPROVED BY
Head or other authorized person of the Medical Organization
Last name, first name, patronymic (if available), signature, seal (if available)
"_" _______ 20

REPORT No. ___
on the Evaluation of the Results of Clinical Trials of a Medical Device for In Vitro Diagnostics
dated "_" _______ 20

(name of medical device)

Prepared by: ________________________
(name of medical organization, indicating the place of clinical trials)

Authority to conduct clinical trial work. License for medical activities No. ___ dated "_" _______ 20, valid until __________

1. During the period from "" _______ 20 to "" _______ 20, ______________(name of medical organization conducting clinical trials) conducted an evaluation of the results of clinical-laboratory trials of ______________________ (name of medical device for in vitro diagnostics (indicating accessories necessary for the use of the medical device or its models (modifications) as intended)) manufactured by ______________-(name of manufacturer, country of manufacture) in accordance with __________________ (name and designation of technical and operational documentation).
2. For conducting clinical-laboratory trials, the following were submitted: _________
   (list of documents, quantity of medical device for in vitro diagnostics)
3. Name of medical organization conducted an evaluation of the results of clinical-laboratory trials of _________________ (name of medical device for in vitro diagnostics) in accordance with the approved program of clinical-laboratory trials:

3.1. Name of medical device (indicating models (modifications), their composition and accessories (if available), trademark and other means of individualization if affixed to the packaging): ________________________
3.2. Type(s) of medical device for in vitro diagnostics in accordance with the nomenclature classification of medical devices: ________________________
3.3. Potential risk class of using the medical device for in vitro diagnostics in accordance with the nomenclature classification of medical devices: ________________________
3.4. Information about the manufacturer or authorized representative of the manufacturer for in vitro diagnostics (legal entity or individual entrepreneur details): ________________________
3.5. Address(es) of production site(s): ________________________
3.6. Grounds for conducting clinical-laboratory trials: ________________________
3.7. Purpose of clinical-laboratory trials: ________________________
3.8. List of regulatory legal acts in accordance with which clinical-laboratory trials are conducted: ________________________
3.9. Information about the Medical Organization (full name, license details, validity period of such license (if available)): ________________________
3.10. Place(s) of measurements (analysis) conducted as part of the clinical-laboratory trials (if different from the location address of the Medical Organization): ________________________
3.11. Information about the medical device for in vitro diagnostics provided for clinical-laboratory trials (quantity, batch/serial numbers, manufacture date, expiry/service life): ________________________
3.12. List of documents submitted for clinical-laboratory trials: ________________________
3.13. Brief description of the medical device for in vitro diagnostics (appearance, purpose): ________________________
3.14. Technical characteristics of the medical device for in vitro diagnostics: ________________________
3.15. Indications and contraindications for use, including information on possible complications of the patient's disease when using the medical device for in vitro diagnostics: ________________________
3.16. Form of clinical-laboratory trials: ________________________
3.17. Plan of clinical-laboratory trials: ________________________
3.18. Methodology of clinical-laboratory trials: ________________________
3.19. Documentation of the conclusions of the results of clinical-laboratory trials: ________________________

4. Characteristics of the material: ________________________
5. Comparison of functional characteristics of medical devices used in the reference method (if available): ________________________
6. Functional qualities of the medical device, effectiveness of its use, indications and contraindications for its use: ________________________
7. Capabilities of the medical device regarding accuracy of measurements, reliability, reproducibility, dependability: ________________________
8. Operational qualities of the medical device, controllability and ease of handling, technical aesthetics, design, stability of the device during operation in a practical laboratory setting: ________________________
9. Information about defects in design and quality of the medical device discovered during clinical trials (if any), features of working with it during operation: ________________________
10. Summary of clinical-laboratory trial results: ________________________
11. Conclusions based on clinical-laboratory trial results: ________________________
12. Evaluation of clinical-laboratory trial results:

CONCLUSION

______________(name of medical device for in vitro diagnostics) complies (does not comply) with the requirements of regulatory documentation, technical and/or operational documentation, as well as the intended use by the manufacturer and the proposed methods of use. The safety and effectiveness of the medical device for in vitro diagnostics are confirmed (not confirmed).

Appendices:

1. Approved program of clinical-laboratory trials.
2. Protocols of clinical trials or results of evaluation and analysis of data, including graphs, images, including from primary medical documentation, confirming clinical observation data, tabulated, statistically processed material, passports for used museum test strains and other collections of pathogenic microorganisms and samples obtained by genetic engineering methods.
3. Data on the use of medical devices for in vitro diagnostics in medical practice (if available).
4. Operational documentation of the manufacturer for the medical device for in vitro diagnostics (including instructions for medical use), in case of revision based on clinical-laboratory trial results. Appendices are an integral part of this Report.

Signatures:

Head of the structural unit of the Medical Organization
________________________ (position, last name, first name, patronymic (if available))

Person authorized by the head of the Medical Organization responsible for preparing the report
________________________ (position, last name, first name, patronymic (if available))

Order of the Ministry of Health of the Russian Federation No. 4n dated June 6, 2012 "On Approval of the Nomenclature Classification of Medical Devices" (registered by the Ministry of Justice of the Russian Federation on July 9, 2012, registration No. 24852), as amended by Orders of the Ministry of Health of the Russian Federation No. 557n dated September 25, 2014 (registered by the Ministry of Justice of the Russian Federation on December 17, 2014, registration No. 35201), No. 686n dated July 7, 2020 (registered by the Ministry of Justice of the Russian Federation on August 10, 2020, registration No. 59225), No. 364n dated June 24, 2025 (registered by the Ministry of Justice of the Russian Federation on August 5, 2025, registration No. 83136).