Order of the Ministry of Health of Russian Federation dated 30 August 2021 No. 885n “On Approval of the Procedure for a Conformity Assessment of Medical Devices in the Form of Technical Tests, Toxicological Studies, and Clinical Trials for the Purpose of the Marketing Authorization of Medical Devices”

In accordance with part 8 of article 38 of Federal Law dated 21 November 2011 no. 323-FZ “On Fundamentals of Healthcare of Russian Federation Citizens” (Collection of Legislative Acts of the Russian Federation, 2011, no. 48, art. 6724, 2021 no. 27, art. 5159) and sub-clause 5.2.187 of the Statute on the Ministry of Health of Russian Federation as approved by Decree of the Government of the Russian Federation dated 19 June 2012 no. 608 (Collection of Legislative Acts of the Russian Federation, 2012, no. 26, art. 3526), I hereby order:

1. To approve this procedure for a conformity assessment of medical devices in the form of technical tests, toxicological studies, and clinical trials for the purpose of the marketing authorization of medical devices.

2. To consider as invalid: order of the Ministry of Health of Russian Federation dated 9 January 2014 no. 2n “On Approval of the Procedure for a Conformity Assessment of Medical Devices in the Form of Technical Tests, Toxicological Studies, and Clinical Trials for the Purpose of the Marketing Authorization of Medical Devices” (registered by the Ministry of Justice of the Russian Federation on 3 April, 2014 under reg. no. 31813);

Order of the Ministry of Health of Russian Federation dated 22 April 2019 no. 239n “On Amendment of the Procedure for a Conformity Assessment of Medical Devices in the Form of Technical Tests, Toxicological Studies, and Clinical Trials for the Purpose of the Marketing Authorization of Medical Devices”, as Approved by Order of the Ministry of Health of Russian Federation dated 9 January 2014 no. 2n, and of Sub-clause 16 of Clause 4 of the Requirements for the Contents of the Technical and Operational Documentation of the Manufacturer (Producer) of the Medical Device, as Approved by Order of the Ministry of Health of Russian Federation dated 19 January 2017, no. 11n (registered by the Ministry of Justice of the Russian Federation on 25 June 2019 under reg. no. 55026).

3. To state that this order does not affect the legal relationships concerning the assessment of the conformity of medical devices, for which the application was submitted by the applicant to the related test laboratory (center) or medical organization before this order entered into full force.

4. This order enters into force on 1 January 2022 and shall be valid until 31 December 2026.

Minister

M.A. Murashko

Registered in the Ministry of Justice of the RF on 12 November, 2021/

reg. no. 65787

APPROVED
by Order of the Ministry
of Health
of Russian Federation
dated 30 August 2021 no. 885n

The procedure for a conformity assessment of medical devices in the form of technical tests, toxicological studies, and clinical trials for the purpose of the marketing authorization of medical devices

I. General

1. The assessment of the conformity of medical devices carried out in the form of technical tests, toxicological studies, and clinical trials for the purpose of the marketing authorization of medical devices, including but not limited to the purpose of the amendment of the contents of the Marketing Authorization Dossier (hereinafter, respectively, referred to as assessment of conformity, technical tests, toxicological studies, clinical trials) has to be performed in accordance with this Procedure and in conformity with the requirements of the applicable legislation of the Russian Federation related to the circulation of medical devices, as well as the requirements set forth in the applicable regulations, technical documentation of the manufacturer (producer) of the medical device concerned, and documentation of the National Standardization System1, which may contain requirements, rules and methods applicable for the tests (trials) and measurements of medical devices.

2. The results of the conformity assessment shall be presented in the form of the following documentation:

a) Statement of Evaluation of the Results of Technical Tests of the Medical Device (see Appendix no. 1 to this Order for the recommended template);

b) Statement of Evaluation of the Results of Technical Tests of the Medical Device for in vitro diagnostics (see Appendix no. 2 to this Order for the recommended template);

c) Statement on the Results of Toxicological Studies of the Medical Device (see Appendix no. 3 to this Order for the recommended template);

d) Statement of Evaluation of the Results of Clinical Trials of the Medical Device (see Appendix no. 4 to this Order for the template);

e) Statement of Evaluation of the Results of Clinical Trials of the Medical Device for in vitro diagnostics (see Appendix no. 5 to this Order for the recommended template).

Test and trial results shall be stored in accordance with the legislation of the Russian Federation on archives 2.

3. The manufacturer (producer) of the medical device or its authorized representative (hereinafter referred to as the Applicant) at its own discretion determines the test laboratory (center) accredited by the National Accreditation System (hereinafter referred to as the Testing Organization) to perform technical tests and/or toxicological studies within the related scope of the accreditation; this Testing Organization also has to determine the Medical Organization responsible for the clinical trials of medical devices, which has to conform with the requirements set forth by the Ministry of Health of Russian Federation3.

Both the Test Organizations and Medical Organizations shall ensure conformity with the fairness doctrine during the related technical tests, toxicological studies and/or clinical trials performed, therefore they shall not have any relationship with or otherwise depend on the developer or manufacturer (producer) of the medical device, or on other persons of interest in relation to the aforementioned tests (studies).

II. The assessment of the conformity of medical devices in the form of technical tests (except medical devices for in vitro diagnostics)

4. Technical tests of medical devices are performed in order to check the quality and safety of the medical device when used in accordance with its intended use as specified in the related documentation of the manufacturer (producer).

5. In order to carry out the technical tests, the Applicant shall submit to the Testing Organization the application for the related technical tests of the medical device concerned, stating the information required by the Rules for the Marketing Authorization of Medical Devices as approved by Decree of the Government of the Russian Federation dated 27 December, 2012 no. 14164, accompanied by the following supporting documentation:

a) technical and operational documentation of the manufacturer (producer) for the medical device;

b) information on the regulatory documentation for the medical device;

c) color photographic images representing a general view of the medical device concerned in all its possible models (variants) and designs, the same for all accessories necessary for the intended use of the medical device concerned (photos shall be a minimum of 18×24 cm), as well as information about packaging and labeling (layouts of the packaging and labels, in color and containing the labeling text in Russian) (except for software considered as a medical device, including software using AI technology);

d) color photographic images of electronic media and the software interface (measuring no less than 18×24 centimeters) (for software that constitutes a medical device, including software using AI technology) (if any);

e) copies of the test protocols related to the preliminary tests of the medical device concerned (if any) (except the software that constitutes a medical device, including software using AI technology);

f) copies of the test protocols related to the preliminary tests of the medical device concerned (including reports on testing, validation and verification of software) (for software that constitutes a medical device, including software using AI technology);

g) copies of the results of technical tests for the medical device performed outside the Russian Federation (if any);

h) a link to the Internet network site from which the software that constitutes a medical device can be downloaded, including software using AI technologies (when the physical e-carrier is not available for such software that constitutes a medical device, including software using AI technologies), as well as a list of keys and access passwords provided by the manufacturer (producer) of the medical device;

j) any drawings, tables and diagrams necessary for the technical tests concerned, if those are available in the operational documentation of the manufacturer (producer) (except software that constitutes a medical device, including software using AI technologies);

k) the manufacturer`s documentation containing information regarding hazards related to the medical device, and to mitigation measures intended for lowering residual risks (if any);

l) the manufacturer`s documentation containing information regarding the life cycle of the medical device concerned (if any) (except software that constitutes a medical device, including software using AI technology);

m) documentation and information related to amendments made to the contents of the Marketing Authorization Dossier, including confirmation documents for such amendments (when the tests are performed in order to make amendments to the information contained in the MAD);

n) a copy of the document confirming the authority of the manufacturer’s (producer’s) authorized representative.

If the documents mentioned above are drawn up in a foreign language, they shall be submitted with a duly certified5 translation into Russian.

6. The Testing Organization shall, within a maximum of 10 working days from the moment of receiving the application and related documentation for technical tests of the medical device, conduct a review (preliminary assessment) of the aforementioned documents to ascertain if the information contained in those documents is sufficient, and therefore decide on whether the technical tests requested are possible to perform.

7. If the Testing Organization decides that the technical tests requested could be performed, they shall together with the Applicant compile a test program, which shall be approved by the head of the organization.

In the event of a negative decision, the Testing Organization shall notify the Applicant in writing, stating the reasons why the technical tests requested cannot be performed; this note shall be delivered personally on condition of the receiver’s signature or sent by regular registered mail (return receipt requested, RRR), or transmitted in e-form via telecommunication channels, or in the form of an e-document signed with an e-signature.

8. Upon approval of this program by the head of the Testing Organization, the Applicant shall submit the following items to the Testing Organization:

a) a sample(s) of the medical device to be tested along with all accessories necessary for its intended use (the number or amount of the supply shall be sufficient for technical tests of this medical device in accordance with the requirements set forth in documentation of the National Standardization Systems6 and in the approved test program);

b) information regarding any import permit for the medical device issued for the purpose of marketing authorization, including those intended for the amendment of the contents of the Marketing Authorization Dossier of the medical device (for medical devices manufactured outside the Russian Federation, or in the event of the import into the Russian Federation of the medical device, for which the manufacturer is a legal entity or individual entrepreneur registered in the Russian Federation, while the manufacturing site is located on the territory of a foreign country, except software that constitutes a medical device, including software using AI technology, and medical devices included in the List of medical devices with a low potential risk profile when used, for which a specific procedure for marketing authorization is applicable, as approved by Decree of the Government of the Russian Federation dated 27 December 2012, no. 14167);

c) any specific equipment developed by the manufacturer for the purpose of technical tests of the medical device concerned, as specified in related specifications (if any) (except the software that constitutes a medical device, including software using AI technology);

d) any specific equipment and/or software, or test databases developed by the manufacturer for the purpose of technical tests of the medical device concerned, as specified in related specifications (if any) (for software that constitutes a medical device, including software using AI technology).

9. For medical devices which require permits (such as licenses) for their testing or installation, or which need major reconstruction of the related hosting site, erection of specific main buildings or structures etc., the technical test may be performed by the representative persons of the Testing Organization directly on the premises of the manufacturer (producer) of this medical device, or on the territory of the Medical Organization hosting this medical device, or on the territory where the operation of this medical device is permitted in accordance with the host country’s legislation.

10. Technical tests of the medical device shall be performed by the Testing Organization within a maximum 30 working days after samples of the medical device concerned and any necessary specific equipment were properly submitted by the Applicant to the Testing Organization (as per paragraph 8 of this Procedure), and on condition of due payment for the services rendered by the Testing Organization as per the related contract. The terms set for technical tests may be extended (upon mutual agreement with the Applicant) by the head of the Testing Organization, but not more than for 20 days.

11. The scope of the technical tests is as follows:

a) identification of the medical device;

b) determination of the potential risk class of the medical device’s operation in accordance with the nomenclature classification of medical devices approved by the Ministry of Health of Russian Federation8;

c) review of documents stated in the paragraph 5 of this Procedure;

d) performance of the tests of the sample (samples) of the medical device along with all accessories necessary for its intended use, as per the approved test program;

e) evaluation and review of the data related to the medical device in question, with the purpose of verifying its quality and safety;

f) providing and issuing the Statement of Evaluation of the Results of the Technical Tests of the Medical Device to the Applicant (this document is either delivered personally or must be sent as a RRR postal package via regular mail).

12. During the technical tests, the following must be determined:

a) conformity of the medical device tested with the related requirements of the applicable documentation of the National Standardization System, as well as with the requirements set forth in various related regulations and the technical and operational documentation of the manufacturer (producer);

b) completeness and objectiveness of the features to be monitored during the technical tests (as set out in the manufacturer’s specifications), as well as related test methods;

c) quality of the medical device and the possibility to operate it in a safe way.

13. The results of the technical tests shall be deemed negative under the following circumstances (if at least one of them pertains):

a) the sample of the medical device (samples) provided, along with the accessories necessary for its intended use, do not conform with the requirements set forth in the regulations, technical and/or operational documentation of the manufacturer (producer), as well as with the applicable documentation of the National Standardization System;

b) the technical and operational documentation provided by the manufacturer (producer) does not support the safety of the medical device concerned;

c) special equipment developed by the manufacturer for the purpose of the technical tests of the specific medical device as per the related specification does not provide the possibility to complete the necessary technical tests.

14. Any other results except those mentioned in paragraph 13 of this Procedure shall be deemed positive and supporting the quality and safe usage of the medical device concerned.

III. Assessment of the conformity of medical devices for in vitro diagnostics in the form of technical tests

15. Technical tests of medical devices for in vitro diagnostics are performed in order to check the quality and safety of the medical device when used in accordance with its intended use as specified in the related documentation of the manufacturer (producer).

Technical tests of medical devices for in vitro diagnostics which constitute an analytical system (assay), performed in relation to a particular medical device along with the accessories, reagent kits and calibrators necessary for the intended usage of this medical device may be conducted as part of the same technical test.

16. In order to perform technical tests for medical devices for in vitro diagnostics, the Applicant must submit to the Testing Organization the application for the related technical tests of a medical device for in vitro diagnostics, stating the information required by the Rules for the Marketing Authorization of Medical Devices as approved by Decree of the Government of the Russian Federation dated 27 December, 2012 no. 14169, accompanied by the following supporting documentation:

a) technical and operational documentation of the manufacturer (producer) for the medical device for in vitro diagnostics;

b) information on the regulatory documentation for the medical device for in vitro diagnostics;

c) color photos representing a general view of the medical device concerned in all its possible models (variants) and designs, the same for all accessories necessary for the intended use of the medical device concerned (photos shall be a minimum of 18×24 cm), as well as information about packaging and labeling (layouts of the packaging and labels, containing the labeling text in Russian);

d) copies of the results of the technical tests for the medical device for in vitro diagnostics performed outside the Russian Federation (if any);

e) copies of the test protocols related to the preliminary tests of the medical device for in vitro diagnostics (if any);

f) any drawings, tables and diagrams necessary for the technical tests of a medical device for in vitro diagnostics, or related software if those are available in the operational documentation of the manufacturer (producer);

g) the set of documents created by the manufacturer in the process of the risk analysis of application (risk management file) (if any);

h) documentation and information related to amendments made to the contents of the Marketing Authorization Dossier, including confirmation documents for such amendments (when the tests are performed in order to make amendments to the information contained in the MAD);

i) a copy of the document confirming the authority of the manufacturer’s (producer’s) authorized representative.

If the documents mentioned above are drawn up in a foreign language, they shall be submitted with a duly certified10 translation into Russian.

17. The Testing Organization shall, within a maximum of 10 working days from the moment of receiving the application and related documentation for technical tests of a medical device for in vitro diagnostics, conduct a review (preliminary assessment) of the aforementioned documents to ascertain if the information contained in those documents is sufficient and therefore decide on whether the technical tests requested are possible to perform.

18. If the Testing Organization decides that the technical tests requested could be performed, they shall together with the Applicant compile a test program, which shall be approved by the head of the organization.

In the event of a negative decision, the Testing Organization shall notify the Applicant in writing, stating the reasons why the technical tests requested cannot be performed; this note shall be delivered personally on condition of the receiver’s signature or sent by regular registered mail (return receipt requested), or transmitted in e-form via telecommunication channels, or in the form of an e-document signed with an e-signature.

19. Upon approval of this program by the head of the Testing Organization, the Applicant shall submit the following items to the Testing Laboratory:

a) a sample(s) of the medical device for in vitro diagnostics to be tested along with all accessories necessary for its intended use (the number or amount of the supply shall be in accordance with the requirements set forth in the documentation of the National Standardization Systems11 and in the approved test program);

b) information regarding any import permit for a medical device for in vitro diagnostics issued for the purpose of marketing authorization, including those intended for the amendment of the contents of the Marketing Authorization Dossier of the medical device (for medical devices manufactured outside the Russian Federation, or in the event of the import into the Russian Federation of a medical device for which the manufacturer is a legal entity or individual entrepreneur registered in the Russian Federation, while the manufacturing site is located on the territory of a foreign country);

c) special equipment necessary for checking and ensuring the proper operation of the medical device for in vitro diagnostics, as specified in the manufacturer’s technical documentation (if available and if necessary).

20. Technical tests of medical devices for in vitro diagnostics shall be performed by the Testing Organization within a maximum 30 working days after samples of the medical device for in vitro diagnostics and any special equipment (if available and if necessary) as per paragraph 19 of this Procedure were duly submitted by the Applicant to the Testing Organization, and on condition of due payment for the services rendered by the Testing Organization as per the related contract.

The terms set out for technical tests of medical devices for in vitro diagnostics may be extended (upon mutual agreement with the Applicant) by the head of the Testing Organization, but not more than for 20 days.

21. The scope of the technical tests for medical devices for in vitro diagnostics is as follows:

a) identification of the medical device;

b) determination of the potential risk class of the medical device’s operation in accordance with the nomenclature classification of medical devices approved by the Ministry of Health of Russian Federation12;

c) review of documents stated in the paragraph 16 of this Procedure;

d) performance of the tests of the sample (samples) of the medical device for in vitro diagnostics along with the accessories necessary for the intended use of the medical device, with the purpose of confirming the performance characteristics listed in the technical and operational documentation of the manufacturer (producer) in accordance with the approved test program, with the exception of the performance characteristics to be tested during clinical and laboratory testing.

Technical tests for reagents, reagent kits, control materials, calibrators, washing solutions and growth media shall be performed within the scope of the identification and validation of the main characteristics.

e) evaluation and review of the data related to the medical device in question, with the purpose of verifying its quality and safety;

f) providing and issuing the Statement of Evaluation of the Results of Technical Tests of the Medical Device for in vitro diagnostics to the Applicant (this document is either delivered personally or must be sent as RRR postal package via regular mail).

22. During the trials, the following must be determined:

a) conformity of the medical device for in vitro diagnostics with the related requirements of the applicable documentation of the National Standardization System, as well as with the requirements set forth in various related regulations and the technical and operational documentation of the manufacturer (producer);

b) conformity of the technical and operational documentation provided by the manufacturer (producer) with the requirements set forth in the applicable documentation of the National Standardization System in relation to medical devices for in vitro diagnostics;

c) completeness and objectiveness of the performance characteristics to be monitored during the technical test (as set out in the manufacturer’s specifications), as well as the related test methods;

d) quality of the medical device for in vitro diagnostics and the possibility of its safe use.

23. The results of the technical tests of the medical device for in vitro diagnostics shall be deemed negative when:

a) the sample(s) of the medical device for in vitro diagnostics provided, along with the accessories necessary for its intended use, do not conform with the requirements set forth in the regulations and technical and/or operational documentation of the manufacturer (producer), as well as the applicable documentation of the National Standardization System;

b) specific equipment developed by the manufacturer for the purpose of technical test of the specific medical device as per related specification, does not provide possibility to complete the technical test;

c) the technical and operational documentation provided by the manufacturer (producer) does not support the quality and safety of the medical device.

24. Any other results of technical tests of the medical devices for in vitro diagnostics except those mentioned in paragraph 23 of this Procedure shall be deemed positive and supporting the quality and safe usage of the medical device concerned.

IV. Assessment of the conformity of medical devices in the form of toxicological studies

25. Toxicological studies of a medical device are performed in relation to medical devices and/or related accessories which are in direct or indirect contact with the human body, mucosa, biological fluids, and such contact is necessary for their intended function and usage.

26. The scope of the toxicological studies is as follows:

a) determination of sanitary and chemical parameters;

b) evaluation of biological parameters in vitro and in vivo. Various types of biological effects may be assessed depending on the nature and duration of contact of the medical device and a human body;

c) microbiological tests (trials).

27. In order to carry out toxicological studies, the Applicant must submit to the Testing Organization an application for the related toxicological studies, stating the information required by the Rules for the Marketing Authorization of Medical Devices as approved by Decree of the Government of the Russian Federation dated 27 December, 2012 no. 141613, accompanied by the following supporting documentation:

a) technical and operational documentation of the manufacturer (producer) for the medical device;

b) information on the regulatory documentation for the medical device;

c) documents containing information about the composition of materials (including the material’s brand name and manufacturer, content of disinfectants, biologically active substances, bio-cellular products, nano-materials, if any), used for manufacturing (producing) the medical device and/or related accessories, as mentioned in paragraph 25 of this Procedure, as well as documents supporting the quality of the aforementioned materials;

d) copies of the documents confirming the quality of the medicinal product, pharmaceutical substance, biological material and other substance from which the medical device was manufactured, or that are included in its composition and which are intended for use only taking into account the purpose of the medical device specified by the manufacturer and issued in accordance with the legislation of the country of origin of the drug, pharmaceutical substance, biological material and other substance;

e) copies of the results of the toxicological studies for medical devices and/or related accessories which were performed outside the Russian Federation (if any);

f) documentation and information related to amendments made to the contents of the Marketing Authorization Dossier, including confirmation documents for such amendments (when the studies were carried out in order to make amendments to the information contained in the MAD);

g) a copy of the document confirming the authority of the manufacturer’s (producer’s) authorized representative.

If the documents mentioned above are drawn up in a foreign language, they shall be submitted with a duly certified14 translation into Russian.

28. The Testing Organization shall, within a maximum of 10 working days from the moment of receiving the application and related documentation for the toxicological studies of the medical device, conduct a review (preliminary assessment) of the aforementioned documents to ascertain if the information contained in those documents is sufficient, and therefore decide on whether the toxicological studies requested are possible to perform.

29. If the Test Organization decides that the toxicological studies requested could be performed, they shall together with the Applicant compile a test program, which shall be approved by the head of the organization.

In the event of a negative decision, the Testing Organization shall notify the Applicant in writing, stating the reasons why the toxicological studies requested cannot be performed; this note shall be delivered personally on condition of the receiver’s signature or sent by regular registered mail (RRR), or transmitted in e-form via telecommunication channels, or in the form of an e-document signed with an e-signature.

30. Upon approval of the test program by the head of the Testing Organization, the Applicant must submit to the Testing Organization a sample (samples) of the medical device or related accessories, as mentioned in paragraph 25 of this Procedure, or materials used for manufacturing (producing) this medical device or related accessories, as mentioned in paragraph 25 of this Procedure, as well as information regarding any import permit for the medical device issued for the purpose of marketing authorization, including those intended for the amendment of the contents of the Marketing Authorization Dossier of the medical device (for medical devices manufactured outside the Russian Federation, or in the event of import into the Russian Federation of a medical device for which the manufacturer is a legal entity or individual entrepreneur registered in the Russian Federation, while the manufacturing site is located on the territory of a foreign country, with the exception of medical devices included in the List of medical devices of a low potential risk profile when used, for which a specific procedure of marketing authorization is applicable, as approved by Decree of the Government of the Russian Federation dated 27 December 2012, no. 141615);

31. Toxicological studies of medical devices shall be performed by the Testing Organization within a maximum of 30 working days after a sample (samples) of the medical device or related accessories mentioned in paragraph 30 of this Procedure were properly submitted by the Applicant to the Testing Organization and on condition of due payment of the services rendered by the Testing Organization as per the related contract.

The terms set out for toxicological studies of medical devices may be extended (upon mutual agreement with the Applicant) by the head of the Testing Organization, but not more than for 20 days, and also in cases when prolonged terms are dictated by the test method or methodology.

32. The scope of the toxicological studies is as follows:

a) identification of the medical device (material);

b) determination of the potential risk class of the medical device’s operation in accordance with the nomenclature classification of medical devices approved by the Ministry of Health of Russian Federation16;

c) determination of the duration of the contact of the medical device with the human body;

d) review of documents stated in the paragraph 27 of this Procedure;

e) carrying out the studies of a sample (samples) of the medical device or related accessory (accessories) in accordance with the approved test program;

f) providing and issuing the Statement of Evaluation of the Results of Toxicological Studies of the Medical Device to the Applicant (this document is either delivered personally or must be sent as a RRR postal package via regular mail).

33. The following shall be determined during the toxicological studies:

a) conformity of the medical device or related accessories tested with the related requirements of the applicable documentation of the National Standardization System, as well as with the requirements set forth in various related regulations and the technical and operational documentation of the manufacturer (producer);

b) conformity of the technical and operational documentation provided by the manufacturer (producer) with the requirements set forth in the applicable documentation of the National Standardization System in relation to medical devices;

c) completeness and objectiveness of the features to be monitored during the toxicological studies of the medical device (as set out in the manufacturer’s technical and operational documentation), as well as the related test methods;

d) safety of usage of the medical device and/or related accessories.

34. Toxicological studies are considered to be negative in the following cases:

a) the sample (samples) of the medical device provided, or related accessories (as mentioned in paragraph 25 of this Procedure), do not conform with the requirements set forth in the regulations and technical and/or operational documentation of the manufacturer (producer), as well as in the applicable documentation of the National Standardization System;

b) the technical and operational documentation provided by the manufacturer (producer) does not support the safety of the medical device.

35. Any other results of the toxicological studies, except those mentioned in paragraph 34 of this Procedure, shall be deemed positive and supporting the quality and safe usage of the medical device concerned.

V. Assessment of the conformity of medical devices in the form of clinical trials (except medical devices for in vitro diagnostics)

36. Clinical trials for medical devices may be arranged as studies (hereinafter referred to as the review and evaluation of clinical data) or as trials, including but not limited to those involving human subjects (hereinafter referred to as trials involving human subjects) performed with the purpose of the evaluation of the safety and efficiency of the medical device concerned.

37. Trials for medical devices involving human subjects are performed under the following circumstances:

a) when a new type of medical device emerges on the market;

b) when certain innovative sophisticated and/or unique/specific methods were developed for diagnostics and the treatment of particular illnesses or conditions, as well as in the case of the application of new and sophisticated medical technologies;

c) when the available clinical data review or assessment failed to confirm the safety and efficiency of the medical device concerned;

d) when medical devices contain new materials previously not investigated for their biological effects, or well known materials for which there is a lack of experience of their medical use in contact with specific organs and tissues of the human body, or if such contact is longer than studied previously.

In all other cases clinical trials for medical devices are to be performed in the form of a review and evaluation of the clinical data.

38. The following documentation and materials must be submitted to the Medical Organization in order to conduct clinical trials:

a) application for clinical trials;

b) sample(s) of the medical device to be evaluated.

For medical devices which require permits (such as licenses) for their installation (commissioning), or which need major reconstruction of the related hosting site, erection of specific main buildings or structures and extra training of operating staff, the trials may be performed by the field personnel directly on the territory of the Medical Organization hosting this medical device, or on the territory where the operation of this medical device is permitted in accordance with the host country’s legislation;

c) permit for clinical trials issued by Roszdravnadzor (except for medical devices with a low potential risk profile when used, software that constitutes a medical device, including software using AI technology, and medical devices included in the List of medical devices with a low potential risk profile when used, for which a specific procedure of marketing authorization is applicable, as approved by Decree of the Government of the Russian Federation dated 27 December 2012, no. 141617, and for clinical trials performed with the purpose of amendment of the contents of the Marketing Authorization Dossier of the particular medical device);

d) technical and operational documentation of the manufacturer (producer) for the medical device;

e) information on the regulatory documentation for the medical device;

f) color photographic images representing a general view of the medical device concerned in all its possible models (variants) and designs, the same for all accessories necessary for the intended use of the medical device concerned (photos shall be a minimum of 18×24 cm), as well as information about packaging and labeling (layouts of the packaging and labels in color and containing the labeling text in Russian) (except software considered as a medical device, including software using AI technology);

g) color photographic images of electronic media and the software interface (measuring no less than 18×24 centimeters) (for software that constitutes a medical device, including software using AI technology) (if any);

h) documents confirming the findings of technical tests of the medical device;

i) documents confirming the results of the toxicological studies of the medical device concerned (for medical devices mentioned in paragraph 25 of this Procedure);

j) documents confirming the findings of tests of the medical device in order to approve the type of measuring instruments (with regard to medical devices related to measuring instruments in the field of the state regulation of traceability, the list of which is approved by the Ministry of Health of Russian Federation)18;

k) documents (materials) containing information regarding the clinical application of the medical device tested, including but not limited to those occurring outside the Russian Federation, including reviews, medical studies reports, literature, presentations, risk analyses and methods of application of the medical device concerned (if any);

l) a link to the Internet network site from which the software that constitutes a medical device can be downloaded, including software using AI technologies (when the physical e-carrier is not available for such software that constitutes a medical device, including software using AI technologies), as well as a list of keys and access passwords provided by the manufacturer (producer) of the medical device;

m) information regarding any import permit for a medical device issued for the purpose of marketing authorization, including those intended for the amendment of the contents of the Marketing Authorization Dossier of the medical device (for medical devices manufactured outside the Russian Federation, or in the event of import into the Russian Federation of a medical device for which the manufacturer is a legal entity or individual entrepreneur registered in the Russian Federation, while the manufacturing site is located on the territory of a foreign country, except software that constitutes a medical device, including software using AI technology, and medical devices included in the List of medical devices with a low potential risk profile when used, for which a specific procedure for marketing authorization is applicable, as approved by Decree of the Government of the Russian Federation dated 27 December 2012, no. 141619);

n) documentation and information related to amendments made to the contents of the Marketing Authorization Dossier, including confirmation documents for such amendments (when the tests are performed in order to make amendments to the information contained in the MAD);

o) a copy of the document confirming the authority of the manufacturer’s (producer’s) authorized representative.

If the original documents are drawn up in a foreign language, they shall be presented with a duly certified translation into Russian.

39. The medical organization shall, within a maximum of 10 days after submitting the application for clinical trials, samples of the medical devices concerned and documents mentioned in paragraph 38 of this Procedure, perform an evaluation (preliminary review) in order to make a decision on the possibility to perform clinical trials as requested.

40. Should the Medical Organization decide positively on the possibility to perform clinical trials, this Medical Organization shall, in cooperation with the Applicant, determine the duration of the clinical trials factoring in the purpose and complexity of the medical device to be tested, and this program shall be approved by the head of the Medical Organization.

In the event of a negative decision, the Medical Organization shall notify the Applicant in writing, stating the reasons why the clinical trial requested cannot be performed; this note shall be delivered personally on condition of the receiver’s signature or sent by regular registered mail (return receipt requested), or transmitted in e-form via telecommunication channels, or in the form of an e-document signed with an e-signature.

41. The program of clinical trials for a medical device, as approved by the head of the Medical Organization responsible for clinical trials of medical devices, together with the documents mentioned in sub-clauses ‘c’ to ‘l’, and sub-clause ‘m’ of clause 38 of this Procedure, if the trial involves human subjects, shall be thereafter submitted by the Applicant to the Ethics Board in the field of the circulation of medical devices at the Ministry of Health of Russian Federation20 (hereinafter referred to as the Ethics Board).

Within a maximum of 30 working days after the documents were submitted for review, the Ethics Board shall issue a conclusion on the ethical justification of the clinical trials of a particular medical device.

42. Clinical trials involving human subjects are to be performed only on the basis of a positive decision of Ethics Board.

In the event of failure of the medical device tested, or if the patient’s health has deteriorated during the clinical trials for this medical device, the head of the Medical Organization responsible for the trials shall suspend or completely terminate these trials with subsequent notification to the Applicant21 stating the reasons for suspension or termination.

43. Trials for software that constitutes a medical device, including software using AI technologies, shall be done on the basis of the medical data obtained during the diagnostics, treatment or rehabilitation and verified by the Medical Organization.

44. The scope of the clinical trials is as follows:

a) analysis and evaluation of the clinical data, documents and materials provided by the Applicant as per paragraph 38 of this Procedure;

b) evaluation of information regarding clinically significant actions, including but not limited to suspension of usage, withdrawal from the market or termination of circulation of the medical device concerned;

c) review of scientific publications and/or unpublished data and reports relative to the intended (as per the manufacturer’s information) usage of the medical device tested and the proposed method of its application;

d) implementation of a test program using sample(s) of the medical device concerned, when trials involving human subjects are planned;

e) evaluation of the plausibility of clinical relation, analytical and clinical validation of the software considered as a medical device, including software using artificial intelligence technologies;

f) amendment of the operational documentation of the manufacturer (producer) for the medical device concerned on the basis of the trial results (if necessary);

g) analysis and evaluation of the information regarding mutually exchangeable medical devices (those being compatible by functionality, quality and performance characteristics, which can be used as substitute devices);

h) providing and issuing the Statement of Evaluation of the Results of Clinical Trials of a Medical Device to the Applicant (this document is either delivered personally or must be sent as a RRR postal package via regular mail).

45. During the clinical trials, the following must be determined:

a) conformity of the medical device with the regulatory documentation requirements, technical and/or operational documentation of the manufacturer (producer);

b) conformity of the documentation provided by the Applicant with the intended use and indications for use set by the manufacturer;

c) completeness and accuracy of performance parameters as set out in the regulations, technical and operational documentation of the manufacturer;

d) quality of the medical device, its efficiency and the possibility to operate it in a safe way.

46. The results of the clinical trials shall be deemed negative in the following cases:

a) when the medical device tested does not comply with the intended purpose and/or intended indications for use, as stated by the manufacturer in its related operational documentation for the medical device concerned;

b) when facts and circumstances are identified which pose a hazard to the life and well-being of the general public and health care professionals, in the event of the use and/or operation of the medical device;

c) when adverse reactions are identified during the tests which are not specified in the IFU or in the operational manual for the medical device tested, or when adverse reactions are reported during the use of the device.

47. Results of the clinical trials in all other cases not mentioned in paragraph 46 of this Procedure are to be deemed positive and supporting the conformity of the medical device with the requirements of safety and efficiency as per the intended use set out in the manufacturer’s (producer’s) documentation.

VI. Assessment of the conformity of medical devices for in vitro diagnostics in the form of clinical trials

48. Clinical trials for medical devices for in vitro diagnostics are performed in a laboratory setting using biomaterials obtained from patients during their diagnostics and treatment process (hereinafter referred to as clinical laboratory trials) with the purpose of monitoring the performance parameters and/or efficiency of the medical device used as per its intended use as set out in the manufacturer’s documentation.

Clinical laboratory trials of medical devices intended for in vitro diagnostics of new infectious diseases or rare endemic diseases must be performed in a laboratory setting using archived test strains from state, national, research or other collections of pathogenic micro-organisms.

Clinical laboratory trials for medical devices for in vitro diagnostics of particularly dangerous infections must be performed by a Test Organization authorized for operations with micro organisms of I–II pathogenic hazard groups.

Clinical laboratory trials of medical devices for in vitro diagnostics which constitute an analytical system (assay), performed in relation to a particular medical device along with the accessories, reagent kits and calibrators necessary for the intended use of the medical device may be conducted as part of the same test.

With regard to medical devices for in vitro diagnostics which require permits (such as licenses) for their installation (commissioning), or which need major reconstruction of the related hosting site, erection of specific main buildings or structures and extra training of the operating staff, the clinical laboratory trials may be performed by the field personnel directly on the territory of the Medical Organization hosting the medical device, provided this Organization has a license for medical practice in the fields corresponding with the intended use of the medical devices tested. The tests during such trials shall be performed using samples of a patient’s biomaterial obtained during diagnostics and treatment on the territory of Russian Federation, and such biomaterial shall be obtained from the reference population, including residual samples, archived samples or purportedly taken samples.

49. In order to have clinical laboratory trials performed, the Applicant shall provide the Organization with the following items:

a) an application for clinical laboratory trials of medical devices for in vitro diagnostics;

b) a sample(s) of the medical device for in vitro diagnostics, along with the accessories necessary for the intended use of the medical device;

c) technical and operational documentation of the manufacturer (producer) for the medical device for in vitro diagnostics;

d) information on the regulatory documentation for the medical device for in vitro diagnostics;

e) documents confirming the results of technical tests for medical devices for in vitro diagnostics;

f) documents confirming the findings of tests of the medical device in order to approve the type of measuring instruments (with regard to medical devices related to measuring instruments in the field of the state regulation of traceability, the list of which is approved by the Ministry of Health of Russian Federation22);

g) documents (materials) containing the results of the review of the application of the medical device for in vitro diagnostics;

h) information regarding any import permit for medical devices for diagnostics issued for the purpose of marketing authorization, including those intended for the amendment of the contents of the Marketing Authorization Dossier of the medical device (for medical devices manufactured outside the Russian Federation, or in the event of import into the Russian Federation of a medical device, for which the manufacturer is a legal entity or individual entrepreneur registered in the Russian Federation, while the manufacturing site is located on the territory of a foreign country);

i) documentation and information related to amendments made to the contents of the Marketing Authorization Dossier, including confirmation documents for such amendments (when the tests are performed in order to make amendments to the information contained in the MAD);

j) a copy of the document confirming the authority of the producer’s (manufacturer’s) authorized representative.

If the documents mentioned above are drawn up in a foreign language, they shall be submitted with a duly certified23 translation into Russian.

50. The organization responsible for the clinical laboratory trials shall, within a maximum of 10 days after receiving the application for clinical laboratory trials of the medical devices for in vitro diagnostics, along with samples of the medical devices for in vitro diagnostics to be tested and related accessories, as mentioned in paragraph 49 of this Procedure, conduct a preliminary evaluation (assessment) of the submitted documents in order to decide about the possibility of the requested clinical laboratory trials of a medical device for in vitro diagnostics.

51. In the event that the organization responsible for the clinical laboratory trials decides positively about the possibility to conduct clinical laboratory trials of a medical device for in vitro diagnostics, this organization shall, together with the Applicant, determine the expected duration of the tests and complete a program of clinical laboratory trials which shall then be approved by the head of the testing organization.

The duration of the clinical laboratory trials shall be determined by the purpose and complexity of the medical device for in vitro diagnostics to be tested.

In the event of a negative decision, the medical organization responsible for the clinical laboratory trials shall notify the Applicant in writing, stating the reasons why the clinical laboratory trials requested cannot be performed; this note shall be delivered personally on condition of the receiver’s signature or sent by regular registered mail (a return receipt requested), or transmitted in e-form via telecommunication channels, or in the form of an e-document signed with an e-signature.

52. The scope of the clinical laboratory trials of medical devices for in vitro diagnostics is as follows:

a) evaluation of the documentation for the medical devices for in vitro diagnostics, specified as per paragraph 49 of this Procedure;

b) clinical laboratory tests for a sample(s) of the medical device for in vitro diagnostics along with the accessories necessary for the intended use of the medical device;

c) evaluation and review of the data obtained and their conformity with the declared performance parameters;

d) amendment of the operational documentation of the manufacturer (producer) for the medical device for in vitro diagnostics on the basis of the trial results (if necessary);

e) providing and issuing the Statement of Evaluation of the Results of Clinical Laboratory Trials of the Medical Device for in vitro diagnostics to the Applicant (this document is either delivered personally or must be sent as a RRR postal package via regular mail).

53. During the trials, the following must be determined:

a) conformity of the medical device for in vitro diagnostics with the regulatory documentation requirements, technical and/or operational documentation of the manufacturer (producer);

b) conformity of the medical device for in vitro diagnostics with the intended use and methods for such use as proposed by the manufacturer;

c) completeness and accuracy of the performance parameters set forth in the regulations, technical and operational documentation of the manufacturer (producer) in terms of the safety and efficiency of the medical device for in vitro diagnostics; in accordance with its intended use as provided by the manufacturer (producer), including but not limited to its diagnostic sensitivity, specificity and reproducibility of results, as well as particular performance characteristics such as analytical sensitivity, specificity, reproducibility, linearity etc., as they are stated in the technical and operational documentation of the manufacture (producer);

d) quality of the medical device, its efficiency and the possibility to operate it in a safe way.

54. Results of the clinical laboratory trials of a medical device for in vitro diagnostics shall be deemed negative when:

a) the conformity of the medical device for in vitro diagnostics with the intended use and methods for such use as proposed by the manufacturer cannot be confirmed;

b) when facts and circumstances are identified which constitute non-efficiency conditions or pose a direct or indirect hazard to the life and well-being of the general public and health care professionals, in the event of the use and/or operation of the medical device.

55. Any other results of the clinical and laboratory trials of the medical devices for in vitro diagnostics except those mentioned in paragraph 54 of this Procedure shall be deemed positive and supporting conformity with the requirements for safety and efficiency as per the intended use proposed by the manufacturer.


1 Federal Law dated 29 June 2015 no. 162-FZ “On Standardization in the Russian Federation” (Collection of Legislative Acts of the Russian Federation, 2015, no. 27, art. 3953; 2021, no. 1, art. 62).

2 Federal Law dated 22 October 2004 no. 125-FZ “On Archiving in the Russian Federation” (Collection of Legislative Acts of the Russian Federation, 2004, no. 43, art. 4169; 2021, no. 24, art. 4188).

3 Order Of the Ministry of Health of Russian Federation dated 16 May 2013, no. 300n “On approval of the requirements for medical organizations performing clinical trials for medical devices, and the procedure for the assurance of the conformity of the medical organization with those requirements” (registered in the Ministry of Justice of the Russian Federation on 4 February 2014, reg. no. 31216).

4 Collection of Legislative Acts of the Russian Federation, 2013, no. 1, art. 14, 2020, no. 49, art. 7897.

5 Article 81 of the Basic Legislation of the Russian Federation on Notaries, as approved by the Supreme Soviet of the Russian Federation on 11 February 1993, no. 4462-1 (Gazette of the Congress of People`s Deputies of the Russian Federation and Supreme Soviet of the Russian Federation, 1993, no. 10, art. 357; Collection of Legislative Acts of the Russian Federation, 2019, no. 52, art. 7798).

6 Federal Law dated 29 June 2015 no. 162-FZ “On Standardization in the Russian Federation” (Collection of Legislative Acts of the Russian Federation, 2015, no. 27, art. 3953; 2021, no. 1, art. 62).

7 Collection of Legislative Acts of the Russian Federation, 2013, no. 1, art. 14; 2020, no. 12, art. 1792.

8 Order of the Ministry of Health of Russian Federation dated 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 Russian Federation dated 25 September 2014, no. 557n (registered by the Ministry of Justice of the Russian Federation on 17 December 2014, reg. no. 35201), and dated 7 July 2020, no. 686n (registered by the Ministry of Justice of the Russian Federation on 10 August 2020, reg. no. 59225).

9 Collection of Legislative Acts of the Russian Federation, 2013, no. 1, art. 14; 2020, no. 49, art. 7897.

10 Article 81 of the Basic Legislation of the Russian Federation on Notaries, as approved by the Supreme Soviet of the Russian Federation on 11 February 1993, no. 4462-1 (Gazette of the Congress of People`s Deputies of the Russian Federation and Supreme Soviet of the Russian Federation, 1993, no. 10, art. 357; Collection of Legislative Acts of the Russian Federation, 2019, no. 52, art. 7798).

11 Federal Law dated 29 June 2015 no. 162-FZ “On Accreditation in the National System of Accreditation” (Collection of Legislative Acts of the Russian Federation, 2015, no. 27, art. 3953; 2021, no. 1, art. 62).

12 Order of the Ministry of Health of Russian Federation dated 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 Russian Federation dated 25 September 2014, no. 557n (registered by the Ministry of Justice of the Russian Federation on 17 December 2014, reg. no. 35201), and dated 7 July 2020, no. 686n (registered by the Ministry of Justice of the Russian Federation on 10 August 2020, reg. no. 59225).

13 Collection of Legislative Acts of the Russian Federation, 2013, no. 1, art. 14; 2020, no. 49, art. 7897.

14 Article 81 of the Basic Legislation of the Russian Federation on Notaries, as approved by the Supreme Soviet of the Russian Federation on 11 February 1993, no. 4462-1 (Gazette of the Congress of People`s Deputies of the Russian Federation and Supreme Soviet of the Russian Federation, 1993, no. 10, art. 357; Collection of Legislative Acts of the Russian Federation, 2019, no. 52, art. 7798).

15 Collection of Legislative Acts of the Russian Federation, 2013, no. 1, art. 14; 2020, no. 12, art. 1792.

16 Order of the Ministry of Health of Russian Federation dated 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 Russian Federation dated 25 September 2014, no. 557n (registered by the Ministry of Justice of the Russian Federation on 17 December 2014, reg. no. 35201), and dated 7 July 2020, no. 686n (registered by the Ministry of Justice of the Russian Federation on 10 August 2020, reg. no. 59225).

17 Collection of Legislative Acts of the Russian Federation, 2013, no. 1, art. 14; 2020, no. 12, art. 1792.

18 Order of the Ministry of Health of Russian Federation dated 15 August 2012, N 89n “On approval of the procedure for tests performed with the purpose of approval of the types of measurements, as well as on approval of the list of medical devices considered as measurement devices in the field of the state regulation of the assurance of measurement uniformity, for which the tests are performed in order to approve the type of measurement device” (Registered by the Ministry of Justice of the Russian Federation on 25 December 2012, reg. no. 26328).

19 Collection of Legislative Acts of the Russian Federation, 2013, no. 1, art. 14; 2020, no. 12, art. 1792.

20 Order of the Ministry of Health of Russian Federation dated 8 February 2013, no. 58n “On approval of the Statement on the Ethics Board in the field of the circulation of medical devices” (registered by the Ministry of Justice of Russian Federation on 5 June 2013, reg. no. 28686).

21 Order> of the Ministry of Health of Russian Federation no. 1113n dated 19 October, 2020, “On approval of the procedure for reporting any adverse events not mentioned in the instructions for use or operational guide for the related medical device, adverse reactions during its usage, specific issues related to medical device interactions, and any other related findings which potentially may pose a threat to the life and health of patients and healthcare personnel using or operating medical devices by entities implementing the circulation of medical devices” (registered by the Ministry of Justice of the Russian Federation on 7 December 2020, reg. no. 61286).

22 Order of the Ministry of Health of Russian Federation dated 15 August 2012, no. 89n “On approval of the procedure for tests performed with the purpose of approval of the types of measurements, as well as on approval of the list of medical devices considered as measurement devices in the field of the state regulation of the assurance of measurement unification, for which the tests are performed in order to approve the type of measurement device” (Registered by the Ministry of Justice of the Russian Federation on 25 December 2012, reg. no. 26328).

23 Article 81 of the Basic Legislation of the Russian Federation on Notaries, as approved by the Supreme Soviet of the Russian Federation on 11 February 1993, no. 4462-1 (Gazette of the Congress of People`s Deputies of the Russian Federation and Supreme Soviet of the Russian Federation, 1993, no. 10, art. 357; Collection of Legislative Acts of the Russian Federation, 2019, no. 52, art. 7798).


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