Decision of the Board of the Eurasian Economic Commission dated February 12, 2016 N. 28
(as amended on March 17, 2022)
«On the Approval of the Rules for Conducting Technical Tests of Medical Devices»
COUNCIL OF THE EURASIAN ECONOMIC COMMISSION
DECISION
dated February 12, 2016. N 28
ON THE APPROVAL OF THE RULES
TECHNICAL TESTING OF MEDICAL DEVICES
| List of amending documents (ed. Decision of the Council of the Eurasian Economic Commission from 17.03.2022 N 25) |
In accordance with paragraph 2 of Article 31 of the Treaty on the Eurasian Economic Union of May 29, 2014, paragraphs 4 and 5 of Article 4 of the Agreement on Uniform Principles and Rules of Circulation of Medical Devices (Medical Devices and Medical Equipment) within the Eurasian Economic Union of December 23, 2014, paragraphs 105 and 106 of Annex N 1 to the Regulations of the Eurasian Economic Commission, approved by the Decision of the Supreme Eurasian Economic Council of December 23, 2014 N 98, and Decision of the Supreme Eurasian Economic Council of December 23, 2014
1. To approve the attached Rules for technical testing of medical devices.
2. This Decision shall enter into force upon expiration of 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 Uniform Principles and Rules of Circulation of Medical Devices (Medical Devices and Medical Equipment) within the Eurasian Economic Union of December 23, 2014, but not earlier than upon expiration of 10 calendar days from the date of official publication of this Decision.
Members of the Council of the Eurasian Economic Commission:
| From the Republic of ArmeniaВ. Gabrielyan | From the Republic of BelarusВ. Matyushevsky | From the Republic of KazakhstanБ. Sagintaev | From the Kyrgyz RepublicО. Pankratov | From the Russian FederationИ. Shuvalov |
Approved
By decision of the Council
Eurasian Economic Commission
dated February 12, 2016. N 28
RULES FOR TECHNICAL TESTING OF MEDICAL DEVICES
| List of amending documents (ed. Decision of the Council of the Eurasian Economic Commission from 17.03.2022 N 25) |
I. General provisions
1. These Rules establish, within the framework of the Eurasian Economic Union (hereinafter — the Union), the procedure for conducting technical tests of medical devices for the purpose of their registration, including requirements for authorized organizations having the right to conduct technical tests (hereinafter — authorized organizations).
2. For the purposes of these Regulations, the terms used shall mean the following:
«tests» — experimental determination of quantitative and (or) qualitative characteristics of properties of the test object as a result of impact on it during its functioning, modeling of the object and (or) impacts on the object;
«test method» — rules for the application of certain test principles and instruments;
«test methodology» — a standard operating procedure including test method, means and conditions of testing, sampling (specimens), algorithms for performing operations to determine one or more interrelated characteristics of object properties, forms of data presentation and calculations required to obtain the result;
«test program» — an organizational and methodological document that establishes the object and objectives of tests, types, methods (techniques) of tests, sequence and scope of experiments, order, conditions, place and terms of tests.
Other concepts used in these Rules shall be applied in the meanings defined by the acts of the Union bodies in the field of medical devices circulation.
3. Technical tests shall be conducted in order to establish compliance of a medical device with the General requirements for the safety and effectiveness of medical devices, requirements for their labeling and operational documentation for them, approved by the Decision of the Council of the Eurasian Economic Commission of February 12, 2016. N 27 (hereinafter — the General Requirements).
4. When conducting technical tests, the requirements of standards included in the list of standards, as a result of the application of which on a voluntary basis fully or partially ensures compliance of medical devices with the General Requirements, as well as the declared technical characteristics of the medical device, which the manufacturer uses to confirm compliance of the medical device with the General Requirements, shall be applied.
In the absence of standards containing rules and methods of research (tests) and measurements included in the said list of standards, for the purposes of technical tests, test methods (techniques) certified (validated) and approved in accordance with the legislation of a Member State of the Union (hereinafter referred to as the Member State) may be used.
5. Technical tests shall be conducted in testing laboratories (centers) selected by the applicant, authorized to conduct technical tests, information about which is included in the unified register of authorized organizations authorized to conduct research (testing) of medical devices for the purpose of their registration (hereinafter — the register of authorized organizations).
Formation and maintenance of the register of authorized organizations is carried out by the Eurasian Economic Commission (hereinafter — the Commission) in accordance with the Procedure for the formation and maintenance of the information system in the sphere of medical devices circulation, approved by the Decision of the Council of the Eurasian Economic Commission dated February 12, 2016. N 30, on the basis of information provided by public authorities of member states authorized to carry out and (or) coordinate activities in the sphere of circulation of medical devices (hereinafter — authorized bodies), using the means of the integrated information system of the Union.
6. Technical tests are not performed on reagents, reagent kits, control materials, calibrators, washing solutions and nutrient media.
7. The results of technical tests shall be considered negative if the submitted samples (specimen) of the medical device do not meet the requirements of the standards, as well as the declared technical characteristics of the medical device, which the manufacturer uses to confirm the compliance of the medical device with the General Requirements.
8. In respect of medical devices, for technical tests or installation (commissioning) of which requires obtaining authorization documentation (e.g., license), construction of separate capital structures or major repairs, it is allowed to conduct technical tests by specialists of the authorized organization on the territory of the manufacturer of the medical device or in the organization where the medical device is placed and (or) allowed for use in accordance with the legislation of the relevant state.
9. Conducting technical tests in cases specified in paragraph 8 of these Rules shall comply with the requirements of the current quality management system of the authorized organization.
10. The authorized organization, which conducts technical tests, as well as specialists of this organization, who conduct technical tests, may not be with the manufacturer of the medical device, its authorized representative or other persons interested in the results of the tests in relations affecting their impartiality.
Commercial, financial, or other pressures that compromise the impartiality of an authorized technical testing organization shall not be permitted.
II. Procedure for technical tests
11. To conduct technical tests, the applicant shall submit to the authorized organization an application containing the following information:
(a) The name of the medical device;
b) name of the applicant, its location (address of a legal entity) — for a legal entity or surname, name, patronymic (if any), place of residence — for an individual registered as an individual entrepreneur, information on state registration of a legal entity or an individual as an individual entrepreneur, as well as contact details of the applicant (telephone number, e-mail address);
c) name of the manufacturer, its location (address of a legal entity) — for a legal entity or surname, name, patronymic (if any), place of residence — for a natural person registered as an individual entrepreneur;
d) information on the production site (production sites) — name of a legal entity or surname, name, patronymic (if any) of an individual registered as an individual entrepreneur, as well as the address of the place of activity;
e) identification features of the medical device sample (make, model, software version, weight, volume, date of production (manufacturing), expiration date (service life), catalog number, factory (serial) number (series number, batch (lot) number), etc.). (if applicable));
f) class of potential risk of use of a medical device, determined in accordance with the Rules for Classification of Medical Devices depending on the potential risk of use, approved by Decision of the Board of the Eurasian Economic Commission dated December 22, 2015 N 173;
g) the purpose and field of application of the medical device.
12. The following documents shall be attached to the application:
operational documentation and technical documentation (technical file) for the medical device, including working drawings, tables and schemes required for technical tests. Requirements for the content of the technical file for a medical device are set out in Annex N 3 to the Rules for clinical and clinical-laboratory tests (studies) of medical devices, approved by the Decision of the Council of the Eurasian Economic Commission of February 12, 2016. N 29, for a medical device for in vitro diagnostics — Appendix N 5 to the Requirements for the implementation, maintenance and evaluation of the quality management system of medical devices depending on potential risk of their use, approved by the Decision of the Council of the Eurasian Economic Commission of November 10, 2017. N 106;
documents containing data on marking and packaging of the medical device (full-color layouts of packages and labels);
draft test program, developed by the applicant, indicating the requirements of standards and (or) declared technical characteristics of the medical device, confirmation of compliance with which the manufacturer will use to prove compliance of the medical device with the General Requirements, as well as test methods (techniques), certified (validated) and approved in accordance with the legislation of the Member States, which are expected to be used;
a list of standards to which the medical device complies, as well as test methods (techniques) certified (validated) and approved in accordance with the legislation of the Member States;
copies of protocols of technical tests conducted in other authorized organizations and confirming compliance of the medical device with the General Requirements, and (or) protocols of in-house tests of the medical device (if any);
other documents confirming compliance of the medical device with the General Requirements (if any).
In case the documents are drawn up in a foreign language, they shall be accompanied by a translation into Russian, certified in accordance with the procedure established by the legislation of the Member State in the territory of which the technical tests are carried out.
13. Within 10 working days from the date of submission of the application specified in paragraph 11 of these Rules, the Authorized Organization shall analyze this application and the documents attached to it and make a decision on the possibility (impossibility) to conduct technical tests.
14. If a decision is made on the possibility of conducting technical tests, the authorized organization shall conclude a relevant contract with the applicant.
15. In case of a decision on impossibility to conduct technical tests, the authorized organization shall notify the applicant in writing of the refusal to conduct technical tests (specifying the reasons), as well as return to the applicant the original documents attached to the application.
16. During the technical tests, the authorized organization shall cooperate with the applicant in connection with the work to be performed.
17. Technical tests shall be conducted on samples of the medical device submitted by the applicant in accordance with the test program.
Sampling of a medical device for technical testing shall be carried out in accordance with the rules defined by standards or certified (validated) test methods (techniques).
18. Sampling of a medical device shall be carried out by the applicant or on its behalf by an authorized organization in the presence of the applicant.
In case the sampling of medical device samples is carried out by the applicant, the results of sampling shall be formalized by the act of acceptance-transfer of medical device samples.
If sampling of a medical device is carried out by an authorized organization on behalf of the applicant, the results of sampling shall be documented by the act of sampling of a medical device.
19. At all stages of storage, transportation and preparation for technical testing of selected samples of the medical device, the requirements set forth in the operating documents for the medical device shall be observed.
20. If there is a group of homogeneous medical devices specified in the test program, it is allowed to conduct technical tests on typical samples of medical devices manufactured according to a single technical documentation.
In this case, the sample of typical samples on the composition of medical devices shall reflect the entire population of the group of homogeneous medical devices, taking into account the differences in the properties of medical devices of individual models (brands) in this group. In case of technical tests on typical samples of medical devices, a corresponding record shall be made in the protocol of technical tests.
21. Technical tests include the following steps:
(a) Analysis of the documents referred to in paragraph 12 of this Regulation;
b) approval of the test program by the authorized organization;
c) taking or obtaining samples of the medical device and identifying them;
d) obtaining special equipment developed by the manufacturer for technical testing of a particular medical device and specified by him in the technical documentation (if necessary);
e) performance of tests stipulated by the test program;
f) execution and issuance to the applicant of the protocol(s) of technical tests of the medical device in the form according to the Annex and the test program.
22. Technical tests shall be conducted by the authorized organization within 30 working days from the date of receipt of samples of medical devices to the authorized organization in accordance with the test program provided that the applicant pays for the work performed by the authorized organization in accordance with the concluded contract. The period of technical tests may be extended by the head of the authorized organization upon agreement with the applicant, but not more than for 20 working days or for another period, provided by the method (methodology) of tests.
23. The results of each technical test or series of technical tests conducted by an authorized organization shall be formulated accurately, clearly, unambiguously and objectively.
24. The protocol of technical tests shall contain information on test methods (techniques) for each determined indicator with the details of the relevant documents (for test methods (techniques) described in standards, the relevant paragraphs of standards shall be indicated).
25. Documents relating to the performance of technical tests shall be kept by the authorized organization in a systematic manner for the period of time specified by the legislation of the Member State.
III. Requirements for authorized organizations and procedure assessing their compliance with these requirements
26. Inclusion of a testing laboratory (center) in the register of authorized organizations shall be carried out in case of its compliance with the following criteria:
a) the registration of the testing laboratory (center) or the organization, which includes the testing laboratory (center), as a legal entity on the territory of the Member State in accordance with its legislation;
b) availability of valid accreditation of the testing laboratory (center) in the national accreditation system of the Member State;
c) availability of a testing laboratory (center) of medical devices and (or) groups of homogeneous medical devices, as well as types and methods of technical tests in the accreditation area;
d) availability of the 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) availability of normative legal acts, documents in the field of standardization, rules and methods of research (tests) and measurements, including rules of sampling (sampling), and other documents in the field of accreditation of the testing laboratory (center), as well as compliance by the testing laboratory (center) with the requirements of these documents;
e) availability of the specialist(s) of the testing laboratory (center) directly performing technical testing:
higher education, or secondary vocational education, or additional vocational education in the profile corresponding to the field of accreditation;
work experience related to technical tests, measurements in the field of accreditation, specified in the register of accredited persons, not less than 2 years.
27. The testing laboratory (center) shall submit to the authorized body an application for inclusion in the register of authorized organizations.
The application shall be accompanied by documents confirming the compliance of the testing laboratory (center) with the criteria specified in paragraph 26 of these Rules.
The application shall contain information on medical devices and (or) homogeneous groups of medical devices, as well as on types and methods of technical tests, which are included in the scope of its accreditation and in respect of which the testing laboratory (center) submits an application.
28. Within 10 working days from the date of receipt from the testing laboratory (center) of the application for inclusion in the register of authorized organizations, the authorized body shall consider the application and notify the testing laboratory (center) of the decision in writing by handing the notification personally against signature to its representative, or sending it by registered mail with return receipt requested, or transmitting it electronically via telecommunication channels or in the form of an electronic document signed by an electronic document.
29. In case of adoption by the authorized body of the decision 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 means of the integrated information system of the Union for inclusion in the register of authorized organizations, and may also be placed on the official website of the authorized body in the information and telecommunication network «Internet».
30. In case of non-compliance of the testing laboratory (center) with one of the criteria specified in paragraph 26 of these Rules and making a decision on refusal to include 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 the notification personally against signature to its representative, or sending it by registered mail with return receipt requested, or transmitting it electronically via telecommunication communication channels
31. Appeal against the decision of the authorized body shall be carried out in accordance with the legislation of the Member State.
32. Storage, systematization and modification of information on authorized organizations, as well as protection from unauthorized access to it shall be ensured by authorized bodies.
33. The Register of Authorized Organizations shall be published on the information portal of the Union.
34. In case of change of data contained in the register of authorized organizations, the authorized organization within 30 calendar days (in case of change of data on accreditation status of the authorized organization in the national accreditation system of the Member State — within 15 working days) shall submit to the authorized body an application for amendments to the specified data, as well as documents confirming these changes.
35. The authorized body shall, within 10 working days from the date of submission by the authorized organization of an application for amendments to the information contained in the register of authorized organizations:
(a) Examine the submitted application and documents specified in paragraph 34 of this Regulation;
b) shall send the relevant information to the Commission using the means of the integrated information system of the Union (in case the authorized body adopts a decision to make changes), and may also post it on its official website in the information and telecommunication network «Internet»;
c) informs the authorized organization about the adopted decision in writing by handing the notification personally against signature to its representative, or sends it by registered mail with acknowledgement of receipt, or transmits 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 shall be 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, which includes the testing laboratory (center), as a legal entity in accordance with the legislation of the Member State or termination of accreditation of the authorized organization in the national accreditation system of the Member State;
c) detection of violations of the procedure of technical testing by the body authorized in accordance with the legislation of the Member State, based on the results of the state control (supervision) exercised by it;
d) untimely submission or non-submission of information and documents stipulated by paragraph 34 of these Rules.
37. The authorized body shall, within 3 working days from the date of taking a decision to exclude information from the register of authorized organizations, ensure the submission of relevant information to the Commission using the means of the integrated information system of the Union.
38. The Commission shall, within 1 working day from the date of receipt of the relevant information, ensure that the register of authorized organizations is updated.
39. Provision of information on authorized organizations at the request of interested parties shall be carried out by authorized bodies in accordance with the legislation of the Member States.
appendix
to the Rules for conducting technical
medical device testing
FORM OF TECHNICAL TEST REPORT FOR A MEDICAL DEVICE
_____________________________________________________________________________
(name of testing laboratory (center))
(information on accreditation of the testing laboratory (center): number, validity period of accreditation (accreditation certificate))
_____________________________________________________________________________
(address and telephone number of the testing laboratory (center))
APPROVED
Head of the testing laboratory
(center)
_______________ ________________
(signature) (last name, initials)
«__» _________________ 20__ г.
(date)
M.P.
PROTOCOL
technical testing of a medical device
N _________
Medical Device Information:
_____________________________________________________________________________
(name, make, model, catalog number (if any), purpose and field of application)
Information about the sample(s) of the medical device:
_____________________________________________________________________________
(quantity, identification features (make, model, software version, weight, volume, date of production (manufacturing), expiration date (service life), catalog number, factory (serial) number (series number, batch (lot) number), etc.) (if applicable)).
The sample(s) of a medical device is a generic sample: _______ yes _______ no
Applicant Information:
_____________________________________________________________________________
(name, location (address of a legal entity) — for a legal entity or surname, name, patronymic (if any), place of residence — for an individual registered as an individual entrepreneur)
_____________________________________________________________________________
(contact details of the applicant (phone number, e-mail address))
Manufacturer Information:
_____________________________________________________________________________
(name, location (address of a legal entity) — for a legal entity or surname, name, patronymic (if any), place of residence — for an individual registered as an individual entrepreneur)
Information about the production site(s):
_____________________________________________________________________________
(name — for a legal entity or surname, name, patronymic (if available) — for an individual registered as an individual entrepreneur, address of the place of business)
Basis for testing:
_____________________________________________________________________________
Information about selection of sample(s) of medical device, date of receipt of sample(s) of medical device:
_____________________________________________________________________________
Standards to which the tests have been performed:
_____________________________________________________________________________
Methods (techniques) of testing:
_____________________________________________________________________________
Testing Location:
_____________________________________________________________________________
Test Start Date: «__» __________ 20__ г.
Test Completion Date: «__» __________ 20__ г.
Conclusion: the medical device samples presented
_____________________________________________________________________________
(meet, do not meet the requirements — specify the necessary)
Submissions:
_____________________________________________________________________________
(name, copy or original document — specify as necessary, number of pages)
Results obtained from the applicant, other authorized organizations, or outside vendors:
_____________________________________________________________________________
List of measuring instruments and test equipment used:
_____________________________________________________________________________
Test results:
Table N _____
| N n/a | Document for which the test was conducted (paragraph of the document) | Name of indicator and (or) document requirements | Test method | Test results <1> | Test conditions (if applicable) <2> | Conclusion |
| 1 | 2 | 3 | 4 | 5 | 6 | 7 |
Specialist of the testing laboratory (center)
__________ _________________
(signature) (last name, initials)
App. Photographic images of the general view of medical device samples with accessories necessary for its intended use (if any) and their labeling.
———————————
<1> Specifying the unit of measurement as well as the uncertainty of measurement (if applicable). The results must be unambiguously correlated with the medical device sample for which they are obtained.
<2> Temperature, humidity, atmospheric pressure, etc.
Notes: 1. The following information should be indicated on the last sheet of the minutes:
«The test results apply only to the medical device samples tested.
Full or partial reprinting of this protocol without the permission of the testing laboratory (center) is prohibited.».
2. The footer of the protocol shall contain information providing unique identification of the protocol, traceability of its components, as well as the end of the protocol.