BEAWIREThe Order of the Ministry of Healthcare of Russia dated Jan 09, 2014 N 2n

The Order of the Ministry of Healthcare of Russia dated Jan 09, 2014 N 2n

The Order of the Ministry of Healthcare of Russia dated Jan 09, 2014 N 2n “On approval of the procedure for the assessment of the compliance of medical devices in the form of technical trials, toxicological studies and clinical trials for medical device state registration purposes” (Registered in the Ministry of Justice of Russia on April 03, 2014. No. 31813).

Registered in the Ministry of Justice of Russia on April 03, 2014. No. 31813

MINISTRY OF HEALTHCARE OF THE RUSSIAN FEDERATION (Minzdrav of Russia)

ORDER

9 January 2014 No. 2n

ON APPROVAL OF THE PROCEDURE

FOR THE ASSESSMENT OF THE COMPLIANCE OF MEDICAL DEVICES IN THE FORM OF TECHNICAL TRIALS, TOXICOLOGICAL STUDIES AND CLINICAL TRIALS FOR

MEDICAL DEVICE STATE REGISTRATION PURPOSES

In accordance with Article 38 of Federal Law No. 323-FZ of November 21, 2011, “On Fundamentals of Public HealthCare in the Russian Federation” (Collection of Laws of the Russian Federation, 2011, No. 48, Art. 6724; 2012, No. 26, Art. 3442, Art. 3446; 2013, No. 27, Art. 3459, Art. 3477; No. 30, Art. 4038; No. 39, Art. 4883; No. 48, Art. 6165) and para. 5.2.187 of the Regulations on the Ministry of Healthcare of the Russian Federation, as approved by Russian Federation Government Resolution No. 608 of June 19, 2012 (Collection of Laws of the Russian Federation, 2012, No. 26, Art. 3526; 2013, No. 16, Art. 1970; No. 20, Art. 2477; No. 22, Art. 2812; No. 33, Art. 4386; No.45, Art. 5822), I hereby order the following:

Approve the Procedure for the Assessment of the Compliance of Medical Devices in the Form of Technical Trials, Toxicological Studies and Clinical Trials for Medical Device State Registration Purposes as set out in the Appendix hereto.

V.I. SKVORTSOVA, the Minister

Appendix to Order of the Ministry of Healthcare

of the Russian Federation No. 2n of January 9, 2014

PROCEDURE

FOR THE ASSESSMENT OF THE COMPLIANCE OF MEDICAL DEVICES IN THE FORM OF TECHNICAL TRIALS, TOXICOLOGICAL STUDIES AND CLINICAL TRIALS FOR

MEDICAL DEVICE STATE REGISTRATION PURPOSES

I.General

1.This Procedure sets out requirements for the assessment of the compliance of medical devices in the form of technical testing, toxicological studies and clinical trials for the purpose of state registration of medical devices (hereinafter “compliance assessment”, “technical trials”, “toxicological studies” and “clinical trials”, respectively).

2. Medical device technical trials, toxicological studies and clinical trials shall be performed in accordance with this Procedure and subject to the requirements of the Russian Federation’s applicable legislation on medical device circulation, standards and technical documentation of the medical device manufacturer, and national (international) standards <1> setting out rules and methods of medical device studies (tests) and measurements.

<1> Federal Law of December 27, 2002, No. 184-FZ “On Technical Regulation” (Collection of Laws of the Russian Federation. 2005, No. 19, Art. 1752; 2007, No. 19, Art. 2293; No. 49, Art. 6070; 2008, No.30, Art. 3616; 2009, No. 29, Art. 3626; No.48, Art. 5711; 2010, No.1, Art. 5, 6; No.40, Art. 4969; 2011, No.30, Art. 4603; No.49, Art. 7025; No.50, Art. 7351; 2012, No.31, Art. 4322; No.50, Art. 6959; 2013, No.30, Art. 4071).

3.Assessment results shall form the basis for issuing:

a) the medical device technical trials report according to the Form provided in Annex 1 hereto;

b) the in-vitro diagnostics medical device technical testing report according to the Form provided in Annex 2 hereto;

c) the medical device toxicological study report according to the Form provided in Annex 3 hereto;

d) the medical device clinical trial report according to the Form provided in Annex 4 hereto;

e) the in-vitro diagnostics medical device clinical trial report according to the Form provided in Annex 5

The test, study and trial results shall be kept in the manner provided for by the Russian Federation’s laws on archiving <1>.

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<1> Federal Law of October 22, 2004, No.125-FZ “On Archiving in the Russian Federation” (Collection of Laws of the Russian Federation, 2004, No.43, Art. 4169; 2006, No.50, Art. 5280; 2007, No.49, Art.6079; 2008, No.20, Art. 2253; 2010, No.19, Art. 2291; 2010, No.31, Art. 4196; 2013, No.7, Art. 611).

4. The medical device manufacturer or its authorized representative (hereinafter the “Applicant”) shall, at its discretion, select a testing organization to perform technical trials and toxicological studies, subject to its accreditation, and a medical organization to perform medical device clinical trials.

II. Compliance assessment in the form of medical device technical trials. Medical device compliance assessment

5. Medical device technical testing shall be performed in the form of tests and/or data evaluation and analysis (hereinafter “tests” and “data evaluation and analysis”, respectively) to verify the medical device’s quality and safety when used for its designated purpose set forth in the manufacturer’s documentation.

6. Technical trials in the form of data evaluation and analysis shall cover only the medical devices which require permits (licenses) for their installation (commissioning), special environment, standalone capital structures, and additional staff training (and in some cases, visiting the medical device’s manufacturing site).

7. Data evaluation and analysis shall comprise:

a) Review of technical publications and information related to safety, operational and design characteristics, as well as the intended medical device’s use;

b) Analysis of the medical device’s testing results; c) Analysis of the medical device’s manufacturing conditions.

8. If the data evaluation and analysis fails to validate the medical device’s quality and safety, the medical device shall undergo technical testing in the form of tests.

9.For the purpose of technical trials, the Applicant shall provide the testing organization with the following items:

a) The medical device’s technical testing application;

b) Sample(s) of the medical device along with the accessories necessary for its intended use (in testing);

c) Copies of the medical device’s preliminary trials reports (if any);

d) Copies of reports on the medical device’s technical testing outside the Russian Federation (if any);

e) Data on the medical device’s regulatory documents;

f) The medical device manufacturer’s documentation, both technical and operational;

g) Photographs of the medical device’s general view with its accessories necessary for the medical device’s intended use (the min. size shall be 18x24cm);

h) Detail drawings, tables and diagrams required for the technical testing, if included in the manufacturer’s operational documentation;

i) Special equipment developed by the manufacture for technical testing of a particular medical device and specified in the technical manufacturing documentation (if any);

j) Documents prepared by the manufacturer with risk analysis when using the medical device and risk management file (if any);

k) Information on the medical device’s clinical use for medical purposes outside the Russian Federation (if any).

In the event of original documents drawn up in a foreign language, they shall be submitted with a certified translation into Russian.

10. Medical device technical trials shall be performed by the testing organization within 30 working days from the date the Applicant provides the testing organization with the documents, sample(s), special equipment (if any), and the medical device specified in 9 hereof. Upon agreement with the Applicant, the testing organization manager may extend the technical trials period, but not more than for twenty working days.

11. Technical trials shall include: a) Medical device identification;

b) Definition of the medical device type and the potential use risk class in accordance with the Medical Device Nomenclature Classification approved by the Ministry of Healthcare of the Russian Federation and agreement thereupon with the Applicant; <1>;

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<1> Order of the Ministry of Healthcare of the Russian Federation dated June 6, 2012, No.4n, “On Approval of the Medical Device Nomenclature Classification” (registered by the Ministry of Justice of the Russian Federation on July 9, 2012, Registration No.24852).

c) Review of the medical device manufacturer’s technical documentation;

d) Drafting a technical testing program (for tests);

e) Testing of the medical device sample(s) (for tests);

f) Evaluation and analysis of the medical device’s data for its quality and safety verification;

g) Updating of the medical device’s technical and operational documentation issued by the manufacturer based on the technical testing results (if applicable) as to:

Completeness and adequacy of the requirements ensuring the medical device’s quality and safety; compliance of the requirements listed in the medical device manufacturer’s documentation with the requirements of applicable national (international) standards;

h) Preparation and delivery (by hand or by registered mail with a receipt) of the medical device’s technical testing report to the Applicant.

12. The technical testing program shall be drawn up together with the Applicant. The testing organization’s manager shall approve the program and method of technical trials.

13. Technical trials shall verify:

а) The medical device’s compliance with the requirements of applicable national (international) standards as well as regulatory documents, technical and operational documents issued by the manufacturer;

b) Compliance of the documentation provided by the Applicant with the requirements of the applicable national (international) standards and the medical device’s regulatory documentation;

c) Completeness and impartiality of the characteristics specified by the manufacturer in the technical documentation, which are subject to technical trials verification, as well as the methods of trials;

d) Possibility to use the manufacturer’s operational documentation when using the medical device for its intended purpose;

e) Quality and safe usage of the medical device.

14. The technical trials results shall be deemed unsatisfactory if one or more of the following occurs:

a) The medical device’s sample(s) provided together with its accessories required for its use as intended do not comply with the requirements of the regulatory documentation, technical and operational manufacturing documentation;

b) The medical device’s information specified in the technical and operational documentation submitted by the manufacturer does not prove its quality and safety;

c) The required technical trials cannot be performed using special technical trials equipment developed by the manufacturer for a particular medical device and specified by the manufacturer in the draft technical documentation.

15. The technical trials results, except for cases specified in 14 hereof, shall be deemed satisfactory and validating the medical device quality and safety.

Compliance assessment of in-vitro diagnostics medical devices

16. Technical trials of in-vitro diagnostics medical devices (devices, equipment, reagent kits, chemical agents, reagents, test-systems, control materials, calibrators, and growth media) shall be performed to verify in-vitro diagnostics medical device performance for assessment of their quality and safety when used as intended by the manufacturer.

Technical trials of in-vitro diagnostics medical devices in the form of closed analytical systems, as performed for the medical device and its accessories, reagent kits and calibrators required for the medical device use for its intended purpose, may be conducted during a single technical test procedure.

17. Technical trials of in-vitro diagnostics medical devices shall be based on:

а) Review of the scientific and technical literature related to safety, efficiency and functionality, as well as the in-vitro diagnostics medical device’s intended use pursuant to the regulatory documentation and the manufacturer’s technical and operational documentation;

b) Review of the in-vitro diagnostics medical device’s test results.

18. The Applicant shall provide the testing organization with the following documents to perform the in-vitro diagnostics medical device’s technical trials:

a) The in-vitro diagnostics medical device’s technical trials application;

b) Sample(s) of the in-vitro diagnostics medical device with its accessories (devices, equipment, reagent kits, chemical agents, reagents, test-systems, control materials, calibrators, and growth media) required for its intended use (in the quantity sufficient for the in-vitro diagnostics medical device’s technical testing according to the requirements of the regulatory documents and the agreed testing program);

c) Copies of the medical device’s preliminary trials reports (if any);

d) Copies of the in-vitro diagnostics medical device’s reports on trials outside the Russian Federation (if any);

e) Information on the in-vitro diagnostics medical device’s regulatory documents;

f) The in-vitro diagnostics medical device manufacturer’s technical and operational documentation;

g) Photographs of the in-vitro diagnostics medical device’s general view with the accessories required for its intended use (the min. size shall be 18x24cm);

h) Tables and diagrams, software required for the in-vitro diagnostics medical device’s technical trials, when such tables, diagrams and software are included in or referenced in the manufacturer’s operational documentation;

i) Special equipment for the medical device’s operational verification or support, as specified in the manufacturer’s technical documentation (if any and if applicable);

j) Set of documents developed by the manufacturer in the process of use risk analysis (risk management file) (if any).

In the event of original documents drawn up in a foreign language, they shall be submitted with a certified translation into Russian.

19. In-vitro diagnostics medical device technical trials shall be performed by a testing organization within 30 working days from the date the Applicant provides the testing organization with the medical device’s documents and sample(s) specified in 18 hereof. Upon agreement with the Applicant, the testing organization manager may extend the in vitro diagnostics medical device’s technical trials period for no more than twenty working days.

Technical trials of the in-vitro diagnostics medical devices for highly dangerous infections shall be performed by the testing organization authorized to work with group I-II pathogenic microorganisms.

20. In-vitro diagnostics medical device technical trials shall include:

а) Medical device identification;

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c) Review of the medical device’s technical manufacturing documentation;

d) Drafting a technical trials program;

e) Technical trials of the sample(s) of the in-vitro diagnostics medical device with its accessories, reagent kits and calibrators required for its intended use to verify the medical device’s performance (analytical sensitivity, specificity, reproducibility, linear and other characteristics) specified in the manufacturer’s technical and operational documentation;

f) Evaluation and analysis of the medical device’s data for its quality and safety verification;

g) Updating of the medical device manufacturer’s draft technical and operational documentation based on the results of the trials (when necessary);

h) Preparation and delivery (by hand or by registered mail with a receipt) of the in vitro diagnostics medical device’s trials report to the Applicant.

21. The in-vitro diagnostics medical device’s technical trials program shall be drawn up together with the Applicant. The manager of the testing organization performing the testing shall approve the program of technical trials for in-vitro diagnostics of the medical devices .

22. Trials shall verify:

А) Compliance of the medical device with the requirements of applicable national (international) standards, as well as regulatory documents, technical and operational documents issued by the manufacturer;

b) Compliance of the documentation provided by the Applicant with the requirements of the applicable national (international) standards and the medical device’s regulatory documentation;

d) Possibility to use the manufacturer’s operational documentation when using the medical device for its intended purpose;

e) Quality and safe usage of the medical device.

23. The in-vitro diagnostics medical device’s technical trials results shall be deemed unsatisfactory if the following occurs:

a) The sample(s) of the in-vitro diagnostics medical device provided for the tests and its related accessories (devices, reagent kits, chemical agents, reagents, test-systems, control materials, calibrators, and growth media) required for its intended use do not comply with the requirements of the regulatory documents or manufacturer’s technical and operational documents.

b) The required technical tests cannot be performed using special technical trials equipment developed by the manufacturer for a particular in-vitro diagnostics medical device and specified by the manufacturer in the draft technical documentation.

24. The in-vitro diagnostics medical device’s technical trials results, except for cases specified in 23 hereof, shall be deemed satisfactory and validating the in-vitro diagnostics medical device’s quality and safety.

III. Compliance assessment in the form of medical device toxicological studies

25. The toxicological study shall be performed for the medical device intended for contact with the human body during its use.

а) Medical device and/or its accessories in contact with the human body surface;

b) medical device designed for intermittent or temporary contact with the human body; c) Medical device designed for implantation into the human body.

26. The medical device’s toxicological study shall be performed to assess its biological effect on the human body and include verification of the following parameters:

а) Physiochemical;

b) Sanitary and chemical;

c) Biological in-vitro and in vivo.

27. The Applicant shall provide the testing organization with the following documents for toxicological studies:

а) Application for toxicological studies;

b) Sample(s) of the medical device or its accessories for contact with the human body surface, or materials used for manufacturing of the medical device and its accessories in contact with the human body surface;

c) Information on the medical device’s regulatory documents;

d) Manufacturer’s technical and operational documentation with the list of national (international) standards the medical device complies with (if applied by the manufacturer);

e) Information on regulatory documents for the materials making up the medical device and/or its accessories in contact with the human body surface specified in 25 hereof.

f) Pharmacopoeia monograph number or, in case of its absence, the number of the regulatory documentation or document for the pharmaceutical substance or drug included in the State Register of Medicines (if the above is used in the medical device)<1>;

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<1> Federal Law of April 12, 2010, No.61-FZ, “On Drug Circulation” (Collection of Laws of the Russian Federation, 2010, No.16, Art.1815; No.31, Art.4161; No.42, Art.5293; No.49, Art.6409; 2011, No.50, Art.7351, 2012, No.26, Art.3442, Art.3446; No.53, Art.7587; 2013, No.27, Art.3477).

g) Documents specifying the composition of the materials used for manufacturing the medical device and/or its accessories in contact with the human body surface;

h) Copies of the reports of the medical device’s toxicological studies (biocompatibility tests) performed outside the Russian Federation (if any).

In the event of original documents drawn up in a foreign language, they shall be submitted with a certified translation into Russian.

28. The medical device’s toxicological studies shall be performed by the testing organization within 30 working days from the date the Applicant provides the testing organization with the medical device’s documents and sample(s) specified in 27 hereof. Upon agreement with the Applicant, the testing organization manager may extend the technical testing period, but not more than for twenty working days.

29. Toxicological studies shall include:

а) Medical device (material) identification;

b) Medical device classification <1>;

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c) Determination of the duration of the medical device’s contact with the human body;

d) Analysis of the medical device’s submitted documentation;

е) Development of a toxicological study program;

f) Implementation of the medical device’s toxicological studies;

g) Completion and delivery (by hand or by registered mail with a receipt) of the medical device’s toxicological study report to the Applicant.

30. The toxicological study program shall be drawn up by the testing organization together with the Applicant and approved by the manager of the testing organization performing the toxicological studies.

31. Single use (disposable) medical devices that are produced in sterile form shall be tested for sterility subject to the positive result of analysis of sterilisation methods and conditions, as well as of methods for their validation and monitoring by the manufacturer.

32. Medical devices in contact with blood and its components, as well as substances for intravascular administration, shall be subject to toxicological studies for pyrogenicity and hemocompatibility.

33. Toxicological studies shall verify:

а) Medical device compliance with the requirements of the applicable national (international) standards, regulatory documents, manufacturer’s technical and operational documents;

b) Compliance of the documentation provided by the Applicant with the requirements of the applicable national (international) standards and the medical device’s regulatory documentation;

c) Completeness and impartiality of the characteristics specified by the manufacturer in the technical and operational documentation, which are subject to monitoring during the medical device’s toxicological studies, as well as the study methods;

d) Safety of the medical device’s usage.

34. The toxicological study results shall be deemed unsatisfactory if the following occurs:

a) Sample(s) of the medical device provided for the tests or its accessories in contact with the human body surface, or the materials used for the manufacturing of the medical device and its accessories in contact with the human body surface, do not comply with the requirements of the regulatory documents or manufacturer’s technical and operational documents;

b) Manufacturer’s technical and operational documentation provided for the tests does not confirm the safety of the medical device’s use.

35. The toxicological study results, except for cases specified in 34 hereof, shall be deemed satisfactory, subject to the systematic approach with due account for the characteristics of all materials used for the manufacturing of the medical device and/or its accessories in contact with the human body surface, and shall validate the safety of the medical device’s use.

IV. Compliance assessment in the form of medical device clinical trials

Medical device compliance assessment

36. The medical device’s clinical trials shall be performed in the form of tests (hereinafter referred to as “analysis and evaluation of clinical data”) and trials, including human ones (hereinafter referred to as “human trials”), held to assess the medical device’s safety and efficiency.

37. Medical devices human trials shall be carried out in the following cases:

а) New medical device type;

b) Application of new complex and/or unique and/or special methods for prevention, diagnostics and treatment of diseases and conditions, as well as application of new complex medical technologies;

c) Failure to verify the medical device’s efficiency and safety by clinical data analysis and evaluation.

In other cases, medical device clinical trials shall be performed in the form of clinical data analysis and evaluation.

38. In order to run clinical trials, the Applicant shall provide the medical organization with:

а) Application for clinical trials;

b) Sample(s) of the medical device (excluding medical devices which require permits (licenses) for their installation (commissioning), special environment, standalone capital structures, and additional staff training and in some cases, visiting the medical device’s manufacturing site);

c) Clinical trial authorization issued by the Federal Service on Healthcare Surveillance in the Russian Federation (Roszdravnadzor) <1>;

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<1> The Russian Federation Government Regulation of December 27, 2012, No.1416, “On Approval of the Medical Device State Registration Rules” (Collection of Laws of the Russian Federation, 2013, No.1, Art.14).

d) Medical device technical testing report with the documents supporting the technical testing results;

e) Medical device toxicological study report with the documents supporting the toxicological study results (for medical devices intended for contact with the human body when used);

f) Results of testing to verify metering equipment types (in respect of the medical devices referring to the metering devices in the state regulation of uniformity of measurements, the list of which is approved by the Ministry of Healthcare of the Russian Federation) <1>;

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<1> Order of the Ministry of Healthcare of the Russian Federation dated August 15, 2012, No.89n, “On Approval of the Testing Procedure to Establish the Types of Metering Devices and the List of Medical Products Classified as Metering Devices in the State Registration of Uniformity of Measurements and Tested to Establish the Types of Metering Devices” (registered by the Ministry of Justice of the Russian Federation on December 25, 2012, registration No.26328).

g) Information on the medical device’s regulatory documents with the list of national (international) standards the medical device complies with (if applied by the manufacturer);

h) The medical device manufacturer’s technical and operational documentation;

i) Photographs of the general view of the medical device with its accessories required for its intended use (the min. size shall be 18x24cm);

j) Documents (materials) containing data on the medical device’s clinical use, including outside the Russian Federation, reviews, scientific reports, publications, presentations, use risk analysis, medical device’s application methods in particular (if any).

In the event of original documents drawn up in a foreign language, they shall be submitted with a certified translation into Russian.

39. The medical device’s clinical trial program and duration shall be agreed upon examination of the medical device’s submitted documents. The clinical trial duration shall be determined by the medical device’s intended use and complexity. The clinical trial program shall be developed by the Applicant together with the medical organization running the medical device clinical trials, in compliance with the requirements specified in the manufacturer’s technical and operational documentation and the regulatory documents.

40. In the event of human trials, the medical device’s clinical trial program approved by the manager of the medical organization carrying out the medical device’s clinical trials, accompanied by the documents specified in subparagraphs “d”-“j” of para. 38 hereof, shall be submitted by the Applicant to the Board of Ethics in Medical Device Circulation of the Ministry of Healthcare of the Russian Federation <1> (hereinafter referred to as the Board of Ethics).

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<1> Order of the Ministry of Healthcare of the Russian Federation of February 8, 2013, No.58n, “On Approval of the Regulation on the Board of Ethics in Medical Device Circulation” (registered by the Ministry of Justice of the Russian Federation on June 5, 2013, registration No.28686).

The Board of Ethics shall issue an ethical review and opinion on the clinical trial of the medical device concerned within 30 working days from receipt of the documents.

41. Human clinical trials on medical devices shall be implemented upon the favorable opinion of the Board of Ethics.

In the event of the medical device’s failure or the patient’s deteriorating condition during the medical device’s clinical trials, the manager of the medical organization which runs the medical device’s clinical trials shall suspend or terminate the trials and notify the Applicant <1> thereof, stating the reasons for suspension or termination.

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<1> Order of the Ministry of Healthcare of the Russian Federation dated June 20, 2012, No.12n, “On Approval of the Reporting Procedure for All Entities Involved In Medical Device Circulation in Events when the Side Effects not Specified in the Medical Device’s IFU / User Manual, or Adverse Effects Associated with the Medical Device’s Application, or the Particular Features of Medical Devices’ Interaction, or the Facts and Circumstances Threatening the Life and Health of Patients and Medical Professionals in Application/ Operation of Medical Devices Are Detected” (registered by the Ministry of Justice of the Russian Federation on July 20, 2012, registration No.24962).

42. If clinical data analysis and evaluation fails to verify the medical device’s efficiency and safety, the medical organization shall notify and refer the Applicant to the Board of Ethics in Medical Device Circulation of the Ministry of Healthcare of the Russian Federation to obtain the ethical review and opinion on the human clinical trial concerned, as per 40 hereof.

43. Clinical trials shall include:

а) Analysis and evaluation of clinical data of the documents and materials submitted by the Applicant under para. 38 hereof;

b) Evaluation of data on clinically significant corrective actions, including the medical device’s application suspension, withdrawal from circulation and recall;

c) Analysis of scientific publications and/or data on file and communications related to the tested medical device’s intended use specified by the manufacturer and its proposed use;

d) Development of a clinical trial program;

e) Trials involving the medical device’s sample(s), in the event of human trials;

f) Updating of the medical device manufacturer’s operational documentation according to trial results (when necessary);

g) Preparation and delivery (by hand or by registered mail with a receipt) of the medical device’s clinical trial report to the Applicant.

44. Clinical trials shall verify:

а) Compliance of the medical device with regulatory documents and the manufacturer’s technical and operational documentation;

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

c) Completeness and accuracy of the medical device’s characteristics as set by regulatory documents and the manufacturer’s technical and operational documentation;

d) Quality of the medical device, the efficiency and safety of its use, including the expected therapeutic effect in respect of therapeutic medical devices.

45. The medical device’s clinical trial results shall be considered unsatisfactory when the following occurs:

а) The medical device does not comply with its intended use and indications for use set by the manufacturer in the medical device’s operational documentation;

b) Any side effects, other than those specified in the medical device’s IFU or user manual, or any adverse effects are identified during its use;

c) Any facts and circumstances threatening the life and health of patients and medical professionals are found during the medical device’s use and operation.

46. Except for cases specified in 45 hereof, the medical device’s clinical trial results shall be deemed satisfactory and shall verify the medical device’s compliance with the safety and efficiency requirements according to its use intended by the manufacturer.

Compliance assessment of in-vitro diagnostics medical devices

47. In-vitro diagnostics medical device clinical trials shall be performed in laboratory conditions, using patients’ biomaterial samples taken during their diagnostics and treatment (hereinafter referred to as “clinical laboratory trials”) to verify the medical device’s performance and/or efficiency in its use as intended by the manufacturer.

In-vitro diagnostics medical device clinical laboratory trials of new infectious diseases or rare feral herd infectious diseases shall be performed in laboratory conditions, using museum test-strains from state, national, research and other collections of pathogenic microorganisms.

In-vitro diagnostics medical device clinical laboratory trials in the form of closed analytical systems run in respect of the medical device with its accessories, reagent kits and calibrators required for its intended use may be carried out as a single trial.

48. To run in-vitro diagnostics medical device clinical laboratory trials, the Applicant shall provide the testing organization with the following items:

а) Application for in-vitro diagnostics medical device clinical laboratory trials;

b) Sample(s) of the in-vitro diagnostics medical device with its accessories (equipment, reagent kits, calibrators, chemical agents, test systems, control materials, calibrators, and growth media) required for its intended use;

c) The in-vitro diagnostics medical device technical testing report supporting the results of the in-vitro diagnostics medical device with its accessories (equipment, reagent kits, calibrators, chemical agents, test systems, monitoring materials, calibrators, and growth media) intended use;

d) Operational documentation for the in-vitro diagnostics medical device with related accessories (equipment, reagent kits, calibrators, chemical agents, test systems, monitoring materials, calibrators, and growth media) required for its intended use (when necessary);

e) Documents (materials) with the medical device’s in-vitro application data analysis (if any);

f) Results of testing to verify metering equipment types (in respect of the in-vitro diagnostics medical devices considered as the measuring devices in terms of the state regulation of uniformity of measurements, as per the list approved by the Ministry of Healthcare of the Russian Federation) <1> (if any).

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In the event of original documents drawn up in a foreign language, they shall be submitted with a certified translation into Russian.

49. The in-vitro diagnostics medical device’s clinical laboratory trial program and duration shall be agreed upon examination of the in-vitro diagnostics medical device’s submitted documents. The duration of the clinical laboratory trial shall be determined by the in vitro diagnostics medical device’s intended use and complexity.

The clinical laboratory trial program shall be developed by the Applicant together with the medical organization running the medical device’s clinical laboratory trials, in compliance with the requirements specified in the manufacturer’s technical and operational documentation and the regulatory documents, and shall be approved by the manager of the medical organization responsible for the aforementioned trials.

50. The in-vitro diagnostics medical device’s clinical laboratory trials shall include:

а) Analysis of the in-vitro diagnostics medical device’s documents provided;

b) Development of a trial program;

c) Clinical laboratory trials of sample(s) of the in-vitro diagnostics medical device with its accessories (equipment, reagent kits, calibrators, chemical agents, test systems, monitoring materials, calibrators, and growth media) required for its intended use;

d) Evaluation and analysis of the obtained data for compliance with the declared characteristics;

e) Updating of the in-vitro diagnostics medical device manufacturer’s operational documentation according to trial results (as applicable);

f) Completion and delivery (by hand or by registered mail with a receipt) of the in vitro diagnostics medical device’s clinical laboratory trial report to the Applicant.

51. Trials shall verify:

а) Compliance of the in-vitro diagnostics medical device with regulatory documents and the manufacturer’s technical and operational documentation;

b) Compliance of the in-vitro diagnostics medical device with its intended use and application methods proposed by the manufacturer;

c) Completeness and accuracy of the declared in-vitro diagnostics medical device’s safety and efficiency characteristics against those set by regulatory documents and the manufacturer’s technical and operational documentation, according to the in-vitro diagnostics medical device’s intended use, including its diagnostic sensitivity, specificity and reproducibility specified in the manufacturer’s technical and operational documentation.

d) Quality of the medical device, the efficiency and safety of its use.

52. The medical device’s clinical laboratory trial results shall be deemed unsatisfactory if the following occurs:

а) The studied medical device does not comply with its intended use and indications for use proposed by the manufacturer;

b) Any facts and circumstances emerge making the medical device inefficient for medical professionals to use and operate, and/or directly or indirectly threatening the life and health of medical professionals using and operating the same.

53. Except for cases specified in 52 hereof, the in-vitro diagnostics medical device’s clinical laboratory trial results shall be deemed satisfactory and shall verify the medical device’s compliance with safety and efficiency requirements according to its use intended by the manufacturer.