Council of the Eurasian Economic Commission Decision No. 28

Resolution of the Council of the Eurasian Economic Commission

dated February 12, 2016, No. 28

"On the Approval of the Rules for Conducting Technical Trials of Medical Devices"

(as amended by the Resolution of the Council of the Eurasian Economic Commission dated March 17, 2022, No. 25)

 

In accordance with paragraph 2 of Article 31 of the Treaty on the Eurasian Economic Union dated May 29, 2014, paragraphs 4 and 5 of Article 4 of the Agreement on Common Principles and Rules for the Circulation of Medical Devices (medical purpose products and medical equipment) within the framework of the Eurasian Economic Union dated December 23, 2014, paragraphs 105 and 106 of Appendix No. 1 to the Regulations on the Work of the Eurasian Economic Commission, approved by the Decision of the Supreme Eurasian Economic Council dated December 23, 2014, No. 98, and the Decision of the Supreme Eurasian Economic Council dated December 23, 2014, No. 109 "On the Implementation of the Agreement on Common Principles and Rules for the Circulation of Medical Devices (medical purpose products and medical equipment) within the framework of the Eurasian Economic Union," the Council of the Eurasian Economic Commission RESOLVED:  

1. To approve the attached Rules for Conducting Technical Trials of Medical Devices.

2. This Resolution shall enter into force after 10 calendar days from the date of entry into force of the Protocol signed on December 2, 2015, on the accession of the Republic of Armenia to the Agreement on Common Principles and Rules for the Circulation of Medical Devices (medical purpose products and medical equipment) within the framework of the Eurasian Economic Union dated December 23, 2014, but no earlier than after 10 calendar days from the date of official publication of this Resolution.

 

Members of the Council of the Eurasian Economic Commission:

From the Republic of Armenia  

V. Gabrielian

 

From the Republic of Belarus  

V. Matyushevsky

 

From the Republic of Kazakhstan  

B. Sagintaev

 

From the Kyrgyz Republic  

O. Pankratov

 

From the Russian Federation  

Shuvalov

 

New Edition. Decision 25 of March 17, 2022, of the EEC Council  

 

APPROVED  

by the Decision of the Council  

of the Eurasian Economic Commission  

of February 12, 2016, No. 28  

(as amended by the Decision of the Council  

of the Eurasian Economic Commission  

of March 17, 2022, No. 25)  

 

RULES

for Conducting Technical Trials of Medical Devices

 

I. General Provisions

 

1. These Rules establish the procedure for conducting technical trials of medical devices within the framework of the Eurasian Economic Union (hereinafter referred to as the Union) for the purpose of their registration, including requirements for authorized organizations entitled to conduct technical trials (hereinafter referred to as authorized organizations).

 

2. For the purposes of these Rules, the following terms are used:

   "trials" – experimental determination of quantitative and/or qualitative characteristics of the properties of the test object as a result of its functioning, modeling of the object, and/or impacts on the object;

   "testing method" – rules for applying specific principles and means of testing;

  "testing procedure" – standard operating procedure that includes the testing method, means and conditions of testing, sample selection, algorithms for performing operations to determine one or more interrelated characteristics of the properties of the object, forms of data presentation and calculations necessary to obtain results;

  "testing program" – organizational and methodological document that establishes the object and goals of testing, types, methods (procedures) of testing, sequence and volume of experiments conducted, order, conditions, location, and timing of testing.

 

   Other terms used in these Rules are applied in the meanings defined by acts of Union bodies in the field of medical device circulation.  

 

3. Technical trials are conducted to establish compliance of medical devices with the General requirements for safety and effectiveness of medical devices, labeling requirements, and operational documentation approved by the Decision of the Council of the Eurasian Economic Commission of February 12, 2016, No. 27 (hereinafter referred to as General requirements).

4. When conducting technical trials, the requirements of standards included in the list of standards are applied, which ensure compliance with General requirements either fully or partially on a voluntary basis, as well as the declared technical characteristics of the medical device that the manufacturer uses to confirm compliance with General requirements.

In the absence of standards containing rules and methods for research (testing) and measurements included in the specified list of standards, methods (techniques) of testing that are certified (validated) and approved in accordance with the legislation of the member state of the Union (hereinafter referred to as the member state) may be used for conducting technical trials.

 

5. Technical trials are conducted in laboratories (centers) selected by the applicant that have the right to conduct technical trials, the information about which is included in the unified register of authorized organizations entitled to conduct trials of medical devices for the purpose of their registration (hereinafter referred to as the register of authorized organizations). The formation and maintenance of the register of authorized organizations are carried out by the Eurasian Economic Commission (hereinafter referred to as the Commission) in accordance with the Procedure for forming and maintaining an information system in the field of medical device circulation, approved by the Decision of the Council of the Eurasian Economic Commission dated February 12, 2016, No. 30, based on information provided by state authorities of member states authorized to carry out and/or coordinate activities in the field of medical device circulation (hereinafter referred to as authorized bodies), using the means of the integrated information system of the Union.

6. Technical trials are not conducted for reagents, reagent kits, control materials, calibrators, washing solutions, and culture media.

7. The results of technical trials are considered negative if the submitted samples (sample) of the medical device do not meet the requirements of the standards, as well as the declared technical characteristics of the medical device that the manufacturer uses to confirm compliance with the General requirements.

8. For medical devices that require obtaining permitting documentation (for example, a license) for technical trials or installation (commissioning), construction of separate capital structures, or major repairs, technical trials may be conducted by specialists from an authorized organization at the premises of the medical device manufacturer or in an organization where the medical device is placed and/or permitted for use in accordance with the legislation of the respective state.

 

9. The conduct of technical trials in cases specified in paragraph 8 of these Rules must comply with the requirements of the current quality management system of the authorized organization.

10. The authorized organization conducting technical trials, as well as specialists from this organization performing technical trials, must not have relationships with the legal manufacturer of medical device, its authorized representative, or other parties interested in the test results that could affect their impartiality. Commercial, financial, or other pressure that threatens the impartiality of the authorized organization conducting technical trials is not permitted.

 

II. Procedure for Conducting Technical Trials

11. To conduct technical trials, the applicant submits an application to the authorized organization containing the following information:

a) Name of the medical device;

b) Name of the applicant, their location (address of the legal entity) – for legal entities, or surname, first name, patronymic (if applicable), place of residence – for individuals registered as individual entrepreneurs, information about the state registration of the legal entity or individual as an individual entrepreneur, as well as the applicant's contact details (phone number, email address);

c) Name of the manufacturer, their location (address of the legal entity) – for legal entities, or surname, first name, patronymic (if applicable), place of residence – for individuals registered as individual entrepreneurs;

d) Information about the production site(s) – name of the legal entity or surname, first name, patronymic (if applicable) of the individual registered as an individual entrepreneur, as well as the address of the location where the activity is carried out;

e) Identification characteristics of the sample medical device (brand, model, software version, weight, volume, date of manufacture, expiration date (service life), catalog number, factory (serial) number (batch number), etc. (if applicable));

f) Class of potential risk associated with the use of the medical device, determined in accordance with the Rules for Classifying Medical Devices Based on Potential Risk of Use, approved by the Decision of the Collegium of the Eurasian Economic Commission dated December 22, 2015, No. 173;

g) Purpose and area of application of the medical device.

 

12. The following documents are attached to the application:

Operating documentation and technical documentation (technical file) for the medical device, including working drawings, tables, and diagrams necessary for conducting technical trials. The requirements for the content of the technical file for the medical device are established by Appendix No. 3 to the Rules for Conducting Clinical and Clinical-Laboratory Trials (Studies) of Medical Devices, approved by the Decision of the Council of the Eurasian Economic Commission dated February 12, 2016, No. 29; for medical devices for in vitro diagnostics – by Appendix No. 5 to the Requirements for Implementation, Maintenance, and Evaluation of Quality Management Systems for Medical Devices Based on Potential Risk of Use, approved by the Decision of the Council of the Eurasian Economic Commission dated November 10, 2017, No. 106;

Documents containing information about the labeling and packaging of the medical device (full-color mock-ups of packaging and labels);

A draft test program developed by the applicant, specifying the requirements of standards and/or the declared technical specifications of the medical device, the confirmation of compliance with which the manufacturer will use to demonstrate compliance of the medical device with the General Requirements, as well as test methods (methodologies), certified (validated) and approved in accordance with the legislation of the member states, which are proposed to be used;

A list of standards to which the medical device complies, as well as test methods (methodologies), certified (validated) and approved in accordance with the legislation of the member states;

Copies of technical trial reports, conducted by other authorized organizations and confirming the compliance of the medical device with the General Requirements, and/or reports of the medical device’s own tests (if available);

Other documents confirming the compliance of the medical device with the General Requirements (if available).

If the documents are drawn up in a foreign language, a translation into Russian, certified in accordance with the legislation of the member state in whose territory the technical trials are carried out, must be attached to them.

 

13. Within 10 working days from the date of submission of the application specified in paragraph 11 of these Rules, the authorized organization analyzes this application and the documents attached to it and decides on the possibility (impossibility) of conducting technical trials.

14. If a decision is made on the possibility of conducting technical trials, the authorized organization concludes an appropriate agreement with the applicant.
Sampling of the medical device for technical trials is carried out in accordance with the rules defined by standards or certified (validated) test methods (methodologies).

18. Sampling of the medical device is carried out by the applicant or, on their behalf, by the authorized organization in the presence of the applicant.

  If the sampling of the medical device is carried out by the applicant, the results of the sampling are documented in acceptance certificate of th medical device.

  If the sampling of the medical device is carried out by the authorized organization on behalf of the applicant, the results of the sampling are documented in a medical device sample selection act.

 

19. At all stages of storage, transportation, and preparation for technical trials of the selected medical device samples, the requirements established in the operational documentation for the medical device must be observed.

 

20. In the presence of a group of homogeneous medical devices specified in the test program, technical trials may be conducted on typical samples of medical devices produced according to unified technical documentation.

  In this case, the selection of typical samples by medical device composition must reflect the entire set of the homogeneous medical device group, taking into account differences in the properties of individual models (brands) of medical devices within that group. In the event of technical trials being conducted on typical medical device samples, a corresponding entry is made in the technical trial report.

 

21. Technical trials include the following stages:

  a) analysis of the documents specified in paragraph 12 of these Rules;

  b) approval of the test program by the authorized organization;

  c) selection or receipt of medical device samples and their identification;

  d) receipt of special equipment developed by the manufacturer for technical trials of a specific medical device and specified by them in the technical documentation (if necessary);

  e) conducting trials provided for by the trial program;

  f) preparation and issuance to the applicant of the medical device technical trial report(s) in the form according to the appendix and the trial program.

 

22. Technical trials are conducted by the authorized organization within 30 working days from the date of receipt of medical device samples by the authorized organization in accordance with the trial program, provided that the applicant has paid for the work performed by the authorized organization in accordance with the concluded agreement. The period for conducting technical trials may be extended by the head of the authorized organization in agreement with the applicant, but not by more than 20 working days or by another period stipulated by the trial method (methodology).

23. The results of each technical trial or series of technical trials conducted by the authorized organization must be formulated accurately, clearly, unambiguously, and objectively.

24. The technical trial report shall provide information on the trial methods (methodologies) for each determined indicator, indicating the details of the relevant documents (for test methods (methodologies) described in standards, the corresponding clauses of the standards shall be indicated).

25. Documents relating to the conduct of technical trials shall be stored by the authorized organization in a systematized manner for the period established by the legislation of the member state.

 

III. Requirements for Authorized Organizations and Procedure for Assessing their Compliance with these Requirements

26. The inclusion of a testing laboratory (center) in the register of authorized organizations is carried out if it meets the following criteria:

 

  a) registration of the testing laboratory (center) or organization that includes the testing laboratory (center) as a legal entity in the territory of the member state in accordance with its legislation;

  b) valid accreditation of the testing laboratory (center) in the national accreditation system of the member state;

  c) presence in the accreditation scope of the testing laboratory (center) of medical devices and/or groups of homogeneous medical devices, as well as types and methods of technical trials;

  d) presence of a quality management system and compliance by the testing laboratory (center) with the requirements of the quality management system established in the quality manual of the testing laboratory (center);

  e) presence of regulatory legal acts, documents in the field of standardization, rules and methods of research (testing) and measurements, including rules for sampling (taking samples), and other documents in the accreditation scope of the testing laboratory (center), as well as compliance by the testing laboratory (center) with the requirements of these documents;

  f) specialist(s) of the testing laboratory (center) directly performing technical trials must have:

    higher education, or secondary vocational education, or additional vocational education in a profile corresponding to the scope of accreditation;

    work experience related to technical trials, measurements in the field of accreditation specified in the register of accredited entities, of at least 2 years.

 

27. The testing laboratory (center) submits an application to the authorized body for inclusion in the register of authorized organizations.

Attached to the application shall be documents confirming the testing laboratory's (center's) compliance with the criteria specified in paragraph 26 of these Rules.

The application shall contain information about medical devices and/or homogeneous groups of medical devices, as well as the types and methods of technical trials that are included in its scope of accreditation and for which the testing laboratory (center) is applying.

 

28. The authorized body, within 10 working days from the date of receipt of the application from the testing laboratory (center) for inclusion in the register of authorized organizations, shall review the said application and inform the testing laboratory (center) of its decision in writing by handing over a notification personally against signature to its representative, or by sending it by registered mail with a delivery notification, or by transmitting it electronically via telecommunication channels or in the form of an electronic document signed with an electronic digital signature.

29. In the event that the authorized body decides to include the testing laboratory (center) in the register of authorized organizations, information about the testing laboratory (center) shall be sent to the Commission using the integrated information system of the Union for inclusion in the register of authorized organizations, and may also be published on the official website of the authorized body on the information and telecommunication network "Internet".

30. In the event of the testing laboratory (center) failing to comply with one of the criteria specified in paragraph 26 of these Rules, and the authorized body deciding to refuse inclusion of the testing laboratory (center) in the register of authorized organizations, the authorized body shall notify the testing laboratory (center) of the reasons for refusal in writing by handing over a notification personally against signature to its representative, or by sending it by registered mail with a delivery notification, or in the electronic kind on telecommunication communication channels or in the form of an electronic document signed with an electronic digital signature.

31. Appeals against the decision of the authorized body shall be carried out in accordance with the legislation of the member state.

32. The storage, systematization, and modification of information about authorized organizations, as well as protection against unauthorized access to it, shall be ensured by the authorized bodies.

33. The register of authorized organizations shall be published on the Union's information portal.

34. In the event of changes to the information contained in the register of authorized organizations, the authorized organization shall, within 30 calendar days (in case of changes to information on the accreditation status of the authorized organization in the national accreditation system of the member state – within 15 working days), submit an application to the authorized body for making changes to the said information, as well as documents confirming these changes.

35. The authorized body, within 10 working days from the date of submission by the authorized organization of an application for making changes to the information contained in the register of authorized organizations:

  a) reviews the submitted application and documents specified in paragraph 34 of these Rules;

  b) sends the relevant information to the Commission using the integrated information system of the Union (in case the authorized body decides to make changes), and may also publish it on its official website on the information and telecommunication network "Internet";

  c) informs the authorized organization of the decision taken in writing by handing over a notification personally against signature to its representative, or by sending it by registered mail with a delivery notification, or by transmitting it electronically via telecommunication channels or in the form of an electronic document signed with an electronic digital signature.

 

36. Exclusion of information from the register of authorized organizations is carried out in the following cases:

  a) submission of an application for exclusion from the register of authorized organizations, signed by the head of the authorized organization;

  b) liquidation of the testing laboratory (center) or the organization that includes the testing laboratory (center), as a legal entity in accordance with the legislation of the member state, or termination of the accreditation of the authorized organization in the national accreditation system of the member state;

  c) identification of violations of the procedure for conducting technical trials by the body authorized in accordance with the legislation of the member state, based on the results of state control (supervision) carried out by it;

  d) untimely submission or non-submission of information and documents provided for in paragraph 34 of these Rules.

 

37. The authorized body, within 3 working days from the date of the decision to exclude information from the register of authorized organizations, ensures the submission of relevant information to the Commission using the integrated information system of the Union.

38. The Commission, within 1 working day from the date of receipt of the relevant information, ensures the updating of the register of authorized organizations.

39. The provision of information about authorized organizations to interested parties upon request is carried out by the authorized bodies in accordance with the legislation of the member states.

 

Appendix

to the Rules for Conducting Technical Trials of Medical Devices

 

FORM

of the medical device technical trials report

 

___________________________________________________________

(Name of testing laboratory (center))

___________________________________________________________

(Information about the accreditation of the testing laboratory (center):

number, validity period of accreditation (accreditation certificate))

___________________________________________________________

(Address and phone number of the testing laboratory (center))

 

APPROVED

Head of the testing

laboratory (center)

 

________ ____________________

(Signature) (Surname, Initials)

" " _______________ 20__

(Date)

 

 Seal

 

TECHNICAL TRIAl REPORT

N _______

 

Information about the Medical Device:

____________________________________________________________

(Name, brand, model, catalogue number (if any), intended purpose and scope of application)

 

Information about the Medical Device Sample(s):

_____________________________________________________________

(Quantity, identification marks (brand, model, software version, mass, volume, date of manufacture, shelf life (service life), catalogue number, factory (serial) number (batch, lot number), etc.) (if applicable))

 

Medical device sample(s) is a typical sample:

 

____Yes ____No

 

Information about the Applicant:

_____________________________________________________________

(Name, location (legal address) – for a legal entity, or surname, first name, patronymic (if any), place of residence – for an individual registered as a sole proprietor)

 

_____________________________________________________________

(Applicant's contact details (phone number, email address))

 

Information about the Manufacturer:

_____________________________________________________________

(Name, location (legal address) – for a legal entity, or surname, first name, patronymic (if any), place of residence – for an individual registered as a sole proprietor)

 

Information about the Production Site(s):

_____________________________________________________________

(Name – for a legal entity, or surname, first name, patronymic (if any) – for an individual registered as a sole proprietor, address of activity)

 

Grounds for Testing:

_____________________________________________________________

Information on the selection of the medical device sample(s), date of receipt of the medical device sample(s):

_____________________________________________________________

Standards to which trials were conducted for conformity:

_____________________________________________________________

Test Methods (Methodologies):

_____________________________________________________________

Place of Testing:

______________________________________________________________

Date of Commencement of Trials: " " __________ 20__

 

Date of Completion of Trials: " " __________ 20__

 

Conclusion: The submitted medical device samples

______________________________________________________________

(Comply, do not comply with the requirements – indicate as applicable)

 

Submitted Documents:

_____________________________________________________________

(Name, copy or original document – indicate as applicable, number of pages)

 

Results obtained from the applicant, other authorized organizations, or external suppliers:

_____________________________________________________________

 

List of Measurement Instruments, Test Equipment Used:

_____________________________________________________________

 

Trial Results:

 

Table N ___

N p/p	Document to which the trial was conducted (document clause)	Name of indicator and/or document requirement	Trial Method	Trial Results¹	Trial Conditions (if applicable)²	Conclusion
1	2	3	4	5	6	7

_____________________________________________________________

 

¹ Indicating the unit of measurement, as well as measurement uncertainty (if applicable). Results must unambiguously correlate with the medical device sample for which they were obtained.

² Temperature, humidity, atmospheric pressure, etc.

 

Specialist of the testing laboratory (center)

 

_______________ ________________________

 (Signature)    (Surname, Initials)

 

Appendix. Photographic images of the general view of medical device samples with accessories necessary for their intended use (if available), and their labeling.

 

Notes:

1. The last page of the report must contain the following information:

  "The trial results relate only to the medical device samples that have undergone testing.

  Full or partial reprinting of this report without the permission of the testing laboratory (center) is prohibited."

 

2. The footer of the report shall contain information ensuring the unique identification of the report, the traceability of its components, and the end of the report.