Decision of the Council of the Eurasian Economic Commission from 16.05.2016 N 38
(as amended on March 17, 2022)
«On Approval of the Rules for Studies (Tests) for Evaluation of Biological Action ofMedical devices».
COUNCIL OF THE EURASIAN ECONOMIC COMMISSION
DECISION
dated May 16, 2016. N 38
ON THE APPROVAL OF THE RULES
CONDUCTING RESEARCH (TESTS) FOR THE PURPOSE OF ASSESSING
THE BIOLOGICAL EFFECTS OF MEDICAL DEVICES
| List of amending documents(ed. Decision of the Council of the Eurasian Economic Commissionfrom 17.03.2022 N 26) |
In accordance with 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 common 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 in order to implement the Decision of the Supreme Eurasian Economic Council of 23 d
1. To approve the attached Rules for conducting research (tests) to assess the biological effect 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 ArmeniaV. GABRIELYAN | FROM the Republic of BelarusV.MATYUSHEVSKY | From the Republic of KazakhstanB. SAGINTAEV | From the Kyrgyz RepublicO. PANKRATOV | From the Russian FederationI. SHUVALOV |
Approved
By decision of the Council
Eurasian Economic Commission
dated May 16, 2016. N 38
RULES.
CONDUCTING RESEARCH (TESTS) FOR THE PURPOSE OF ASSESSING
THE BIOLOGICAL EFFECTS OF MEDICAL DEVICES
| List of amending documents (ed. Decision of the Council of the Eurasian Economic Commission from 17.03.2022 N 26) |
I. General provisions
1. These Rules establish within the framework of the Eurasian Economic Union (hereinafter — the Union) the procedure for conducting research (tests) to assess the biological effect of medical devices for registration (hereinafter — research (tests)), including requirements for authorized organizations that have the right to conduct research (tests) (hereinafter — authorized organizations).
2. For the purposes of these Regulations, the terms used shall mean the following:
«medical device category» — a classification attribute of a medical device determined when selecting methods for evaluating the biological effect of a medical device depending on the group, type and duration of contact of the medical device;
«material» means a synthetic or natural polymer, metal, alloy, ceramic, or other non-viable material, including non-viable biological tissue (lacking the potential for metabolism or reproduction), used as a medical device or part thereof;
«medical device specimen» means a product or a representative part thereof directly subjected to examination (testing);
«typical sample of a medical device» — a sample selected from a group of medical devices belonging to the same category, produced by one manufacturer under the same technical documentation and having the same composition (material), area and conditions of use. In this case, the selection of standard 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.
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 Studies (tests) shall be conducted 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 research (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 methods (techniques) of research (tests), certified (validated) and approved in accordance with the legislation of a Member State of the Union (hereinafter — Member State) shall be applied.
5. Investigations (tests) shall be conducted in testing laboratories (centers) selected by the applicant, information about which is included in the unified register of authorized organizations authorized to conduct investigations (tests) of medical devices for the purposes 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. Investigations (tests) shall be carried out in respect of medical devices and (or) accessories thereto, directly or indirectly contacting the surface of the human body, its mucous membranes, internal environment of the body, for which the specified interaction (contact) is necessary for the performance of their function.
7. The results of research (tests) shall be considered negative if the submitted samples (specimen) of the medical device do not meet the safety requirements.
8. The authorized organization, which conducts research (tests), as well as specialists of this organization, conducting research (tests), may not be with the manufacturer of the medical device, its authorized representative or other persons interested in the results of research (tests) in relations affecting their impartiality.
Commercial, financial or other pressures that jeopardize the impartiality of the authorized organization conducting research (testing) are not allowed.
II. Procedure for conducting research (tests)
9. Studies (tests) include:
(a) Determination of sanitary and chemical indicators;
b) in vitro and in vivo evaluation of biological effects. The types of biological effect to be evaluated are based on the category of the medical device;
c) microbiological studies (tests).
10. To conduct research (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, 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.
11. 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 necessary for conducting trials (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 (trials) 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 the 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);
list of standards to which the medical device complies, as well as methods (techniques) of research (tests), certified (validated) and approved in accordance with the legislation of the Member State;
copies of protocols of research (tests) of the medical device and (or) materials from which the medical device and (or) its accessories are made, conducted in other authorized organizations and confirming compliance of the medical device with the General Requirements, and (or) protocols of own research (tests) of the medical device (if any);
documents containing information on medicinal products in the medical device, their composition, quantity, compatibility of the medicinal product with the medical device (if there are medicinal products in the medical device);
documents containing information on materials (including the composition, brands and manufacturers of materials, the presence of disinfectants, biologically active substances, biocellular products, nanomaterials) from which the medical device and (or) its accessories are made, as well as documents confirming their compliance with the declared characteristics;
other documents confirming compliance of the medical device with the General Requirements (if any).
If 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 on whose territory the research (testing) is conducted.
12. Within 10 working days from the date of submission of the application specified in paragraph 10 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 research (testing).
13. If a decision is made on the possibility of conducting research (testing), the authorized organization shall conclude a relevant contract with the applicant.
14. If a decision is made that it is impossible to conduct research (testing), the authorized organization shall notify the applicant in writing of the refusal to conduct research (testing) (specifying the reasons), and shall return to the applicant the original documents attached to the application.
15. In the course of research (testing), the authorized organization shall cooperate with the applicant in connection with the work performed.
16. When concluding a contract for research (testing):
(a) The category of medical device shall be determined;
b) a research (testing) program shall be developed by the authorized organization jointly with the applicant;
c) the research (testing) program shall be agreed with the applicant and approved by the head of the authorized organization.
17. Research (tests) shall be conducted on samples of the medical device submitted by the applicant in accordance with the program of research (tests).
Sampling of a medical device for research (testing) shall be carried out in accordance with the rules defined by standards or certified (validated) methods (techniques) of research (testing).
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 research (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 research (testing) program, it is allowed to conduct research (testing) on typical samples of medical devices.
In the case of research (testing) on prototypes, a corresponding entry shall be made in the protocol of research (testing).
21. Research (testing) includes the following stages:
(a) Analysis of the documents referred to in paragraph 11 of this Regulation;
b) adjustment of the research (testing) program (if necessary);
c) obtaining standard samples (if necessary);
d) taking or obtaining samples of the medical device and their identification on the basis of the data submitted by the applicant;
e) conducting research (tests) of the medical device provided for by the program of research (tests);
f) execution and issuance to the applicant of a protocol of research (tests) in the form according to the annex and the program of research (tests).
22. Research (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 program of research (tests), provided that the applicant pays for the work performed by the authorized organization in accordance with the concluded contract. The period of research (testing) may be extended in cases where a longer period is provided for by the method (methodology) of research (testing).
23. The results of each research (test) or series of research (tests) conducted by an authorized organization shall be formulated accurately, clearly, unambiguously and objectively.
24. The protocol of research (testing) provides information on methods (techniques) of research (testing) for each determined indicator with the details of the relevant documents (for methods (techniques) of research (testing) described in the standards, the relevant paragraphs of the standards shall be indicated).
25. Documents concerning the conduct of research (tests) shall be kept by the authorized organization in a systematized form for the period of time established 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 in the accreditation area of a testing laboratory (center) of medical devices and (or) groups of homogeneous medical devices, as well as types and methods of research (testing);
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 (techniques) of investigations (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;
f) availability of a specialist (specialists) of the testing laboratory (center) directly performing work on research (testing):
higher education, or secondary vocational education, or additional vocational education in the profile corresponding to the field of accreditation;
at least 2 years of work experience related to research (tests), measurements in the field of accreditation specified in the register of accredited persons.
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 research (testing), 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 against 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 the 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 making changes in 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 for conducting research (tests) 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 Research
(tests) to assess the biological
medical devices
PROTOCOL FORM
RESEARCH (TESTING) TO ASSESS THE BIOLOGICALMEDICAL DEVICE PERFORMANCE
___________________________________________________________
(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
studies (tests) to assess the biological effect of a medical device
N _________
Medical Device Information:
___________________________________________________________________________
(name, make, model, catalog number (if any), purpose and field of application)
Materials of the medical device and its accessories (if any) in contact with the human body:
___________________________________________________________________________
Information about the sample(s) of the medical device:
___________________________________________________________________________
(quantity, identification features (make, model, 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 person 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)
Grounds for conducting research (tests):
_________________________________________________________________________________________
Information on selection of sample(s) of medical device, date of receipt of sample(s) of medical device:
_________________________________________________________________________________________
Standards, for compliance with which the studies (tests) were conducted:
_________________________________________________________________________________________
Methods (techniques) of research (testing):
_________________________________________________________________________________________
Place of research (testing):
_________________________________________________________________________________________
Date of the beginning of the research (testing):
«__» _______ 20__ г.
Date of completion of research (testing):
«__» _______ 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 external suppliers:
_________________________________________________________________________________________
List of measuring instruments and test equipment used:
_________________________________________________________________________________________
Research (test) results:
Table N ____
| N n/a | Document, for compliance with which the research (test) was conducted (paragraph of the document) | Name of indicator and (or) document requirements | Method of research (testing) | Results of research (testing) <1> | Conditions of research (testing) (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 included on the last sheet of the minutes:
«The results of research (testing) refer only to samples of a medical device that have been 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.