Council of the Eurasian Economic Commission Decision No. 38

Decision of the Council of the Eurasian Economic Commission

of May 16, 2016, No. 38

"On Approval of the Rules for Conducting Trials

to Assess the Biological Effects of Medical Devices"

 

(as amended by the Decision of the Council of the Eurasian Economic Commission

of March 17, 2022, No. 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 for the Circulation of Medical Devices (Medical Products and Medical Equipment) within the Eurasian Economic Union of December 23, 2014, paragraphs 105 and 106 of Annex No. 1 to the Regulations of the Eurasian Economic Commission, approved by the Decision of the Supreme Eurasian Economic Council of December 23, 2014, No. 98, and in order to implement the Decision of the Supreme Eurasian Economic Council of December 23, 2014, No. 109 "On the Implementation of the Agreement on Common Principles and Rules for the Circulation of Medical Devices (Medical Products and Medical Equipment) within the Eurasian Economic Union," the Council of the Eurasian Economic Commission DECIDES:

 

1. To approve the attached Rules for Conducting Trials to Assess the Biological Effects of Medical Devices.

2. This Decision shall enter into force upon the 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 Common Principles and Rules for the Circulation of Medical Devices (Medical Products and Medical Equipment) within the Eurasian Economic Union of December 23, 2014, but not earlier than upon the expiration of 10 calendar days from the date of the official publication of this Decision.

Members of the Council of the Eurasian Economic Commission:

 

From the Republic of Armenia

V. Gabrielyan

 

From the Republic of Belarus

V. Matyushevsky

 

From the Republic of Kazakhstan

B. Sagintayev

 

From the Kyrgyz Republic

O. Pankratov

 

From the Russian Federation

I. Shuvalov

(New Edition, Decision No. 26 of the EEC Council of March 17, 2022)

 

Approved by

Decision of the Council

of the Eurasian Economic Commission

of May 16, 2016, No. 38

(as amended by the Decision of the Council

of the Eurasian Economic Commission

of March 17, 2022, No. 26)

 

RULES

FOR CONDUCTING TRIALS TO ASSESS THE BIOLOGICAL EFFECTS OF MEDICAL DEVICES

 

I. General Provisions

 

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

2. For the purposes of these Rules, the following concepts are used, which mean the following:

"category of medical device" means a classification characteristic of a medical device, determined when selecting methods for assessing the biological effects 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 (not having the potential for metabolism or reproduction), used as a medical device or part thereof;

"sample of a medical device" means a device or its representative part that is directly subjected to a trial;

"typical sample of a medical device" means a sample selected from a group of medical devices belonging to the same category, manufactured by the same legal manufacturer of medical device according to the same technical documentation and having the same composition (material), scope and conditions of use. At the same time, the selection of typical samples by the composition of medical devices should reflect the entire set of homogeneous medical devices, taking into account differences in the properties of medical devices of individual models (brands) in this group.

 

Other concepts used in these Rules are used in the meanings defined by the acts of the Union bodies in the field of circulation of medical devices.

 

3. Trials are carried out in order to establish the conformity of a medical device with the General Requirements for the Safety and Effectiveness of Medical Devices, requirements for their labeling and operational documentation, approved by Decision No. 27 of the Council of the Eurasian Economic Commission of February 12, 2016 (hereinafter referred to as the "General Requirements").

4. When conducting trials, the requirements of standards included in the list of standards, as a result of the application of which compliance of medical devices with the General Requirements is fully or partially ensured on a voluntary basis, as well as methods (methodologies) of trials certified (validated) and approved in accordance with the legislation of the Member State of the Union (hereinafter referred to as the "Member State") are applied.

5.Trials are conducted in test laboratories (centers) selected by the applicant, 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 the Formation and Maintenance of the Information System in the Field of Circulation of Medical Devices, approved by Decision No. 30 of the Council of the Eurasian Economic Commission of February 12, 2016, based on information provided by the state authorities of the Member States authorized to carry out and (or) coordinate activities in the field of circulation of medical devices (hereinafter referred to as the "authorized bodies"), using the means of the integrated information system of the Union.

 

6. Trials are carried out in relation to medical devices and (or) accessories thereto that directly or indirectly come into contact with the surface of the human body, its mucous membranes, internal environments of the body, for which the indicated interaction (contact) is necessary for the performance of their function.

7. The results of trials are considered negative if the presented samples (sample) of the medical device do not meet the safety requirements.

8. The authorized organization that conducts trials, as well as the specialists of this organization who conduct trials, may not be in relations with the manufacturer of the medical device, its authorized representative, or other persons interested in the results of trials that affect their impartiality.

 

Commercial, financial, or other pressure that puts the impartiality of the authorized organization conducting trials at risk is not allowed.

 

II. Procedure for Conducting Trials

9. Trials include:

a) determination of sanitary and chemical indicators;

b) assessment of biological effects under in vitro and in vivo conditions. The types of biological action are subject to assessment based on the category of medical device;

c) microbiological trials.

 

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

a) name of the medical device;

b) name of the applicant, its location (legal address) - for a legal entity, or surname, first name, patronymic (if any), place of residence - for an individual registered as an individual entrepreneur, information on state registration of the legal entity or individual as an individual entrepreneur, as well as contact details of the applicant (phone number, email address);

c) name of the manufacturer, its location (legal address) - for a legal entity, or surname, first name, patronymic (if any), place of residence - for an individual registered as an individual entrepreneur;

d) information about the production site(s) - name of the legal entity or surname, first name, patronymic (if any) of the individual registered as an individual entrepreneur, as well as the address of the place of business;

e) identification marks of the medical device sample (brand, model, mass, volume, date of manufacture, expiration date (service life), catalog number, factory (serial) number (number of series, batch (lot)), etc. (if applicable));

f) class of potential risk of use of the medical device, determined in accordance with the Rules for Classification of Medical Devices depending on the potential risk of use, approved by Decision No. 173 of the Board of the Eurasian Economic Commission of December 22, 2015;

g) intended use and scope of application of the medical device.

 

11. The following documents are attached to the application:

operational documentation and technical documentation (technical file) for the medical device, including working drawings, tables and diagrams necessary for conducting trials. The requirements for the content of the technical file for a medical device are established by Annex No. 3 to the Rules for Conducting Clinical and Clinical Laboratory Trials of Medical Devices, approved by Decision No. 29 of the Council of the Eurasian Economic Commission of February 12, 2016, for a medical device for in vitro diagnostics - by Annex No. 5 to the Requirements for the Implementation, Maintenance and Evaluation of a Quality Management System for Medical Devices depending on the potential risk of their use, approved by Decision No. 106 of the Council of the Eurasian Economic Commission of November 10, 2017;

documents containing data on the labeling and packaging of the medical device (full-color layouts of packaging and labels);

a list of standards to which the medical device conforms, as well as methods (methodologies) of trials certified (validated) and approved in accordance with the legislation of the Member State;

copies of protocols of trials of the medical device and (or) materials from which the medical device and (or) accessories thereto are made, carried out in other authorized organizations and confirming the compliance of the medical device with the General Requirements, and (or) protocols of own trials of the medical device (if available);

documents containing information on medicinal products (drugs) in the composition of the medical device, their composition, quantity, and the compatibility of the medicinal product with the medical device (if medicinal products are part of the medical device);

documents containing information on the materials (including composition, grades and manufacturers of materials, presence of disinfectants, biologically active substances, biocellular products, nanomaterials) from which the medical device and/or its accessories are manufactured, as well as documents confirming their conformity to the declared characteristics;

other documents confirming the medical device's compliance with the General Requirements (if available).

If the documents are drawn up in a foreign language, a translation into Russian, certified in the manner established by the legislation of the Member State on whose territory the trials are conducted, must be attached.

 

12. The authorized organization shall, within 10 working days from the date of submission of the application specified in paragraph 10 of these Rules, review this application and the attached documents and make a decision on the feasibility (or infeasibility) of conducting the trials.

13. If a decision is made to proceed with the trials, the authorized organization shall conclude a corresponding agreement with the applicant.

 

14. If a decision is made not to proceed with the trials, the authorized organization shall notify the applicant in writing of the refusal to conduct the trials (stating the reasons) and shall return the original documents attached to the application to the applicant.

15. During the conduct of the trials, the authorized organization shall cooperate with the applicant regarding the work being performed.

16. When concluding an agreement for conducting trials:

a) the category of the medical device is determined;

b) a program of trials is developed by the authorized organization jointly with the applicant;

c) the program of trials is agreed with the applicant and approved by the head of the authorized organization.

 

17. Trials are conducted on samples of the medical device submitted by the applicant in accordance with the program of trials.

The selection of samples of the medical device for conducting trials is carried out in accordance with the rules defined by standards or certified (validated) methods (methodologies) of trials.

 

18. The selection of samples of the medical device is carried out by the applicant or, on his/her behalf, by the authorized organization in the presence of the applicant.

If the selection of samples of the medical device is carried out by the applicant, the results of the selection are documented in a record of acceptance and transfer of samples of the medical device.

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

 

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

20. In the presence of a group of homogeneous medical devices specified in the program of trials, it is allowed to conduct trials on typical samples of medical devices.

If trials are carried out on typical samples, a corresponding entry is made in the protocol of trials.

21. Trials include the following stages:

a) analysis of the documents specified in paragraph 11 of these Rules;

b) adjustment of the program of  trials(if necessary);

c) obtaining standard samples (if necessary);

d) selection or receipt of samples of the medical device and their identification based on the data submitted by the applicant;

e) conducting trials of the medical device provided for in the program of trials;

f) preparation and issuance to the applicant of the protocol of trials in the form according to the Appendix and the program of trials.

 

22. Trials are conducted by the authorized organization within 30 working days from the date of receipt of the samples of medical devices by the authorized organization in accordance with the program of trials, provided that the applicant pays for the work performed by the authorized organization in accordance with the concluded agreement. The duration of the trials may be extended in cases where a longer period is provided for by the method (methodology) of the trials.

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

24. The protocol of trials shall provide information on the methods (methodologies) of trials  for each determined indicator, indicating the details of the relevant documents (for methods (methodologies) of trials described in standards, the relevant clauses of the standards are indicated).

25. Documents relating to the conduct of trials shall be stored by the authorized organization in a systematic manner for the period established by the legislation of the Member State.

 

III. Requirements for Authorized Organizations and the Procedure for Assessing Their Compliance with These Requirements

 

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

a) registration of the test laboratory (center) or organization that includes the test laboratory (center) as a legal entity in the territory of the Member State in accordance with its legislation;

b) the presence of a valid accreditation of the test laboratory (center) in the national accreditation system of the Member State;

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

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

e) the presence of regulatory legal acts, documents in the field of standardization, rules and methods (methodologies) of trials and measurements, including rules for the selection of samples (probes), and other documents in the field of accreditation of the test laboratory (center), as well as compliance by the test laboratory (center) with the requirements of these documents;

f) the availability to the specialist(s) of the test laboratory (center) directly performing work on trials of:

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

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

 

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

The application shall be accompanied by documents confirming the compliance of the test laboratory (center) with the criteria specified in paragraph 26 of these Rules.

The application shall indicate information on medical devices and (or) homogeneous groups of medical devices, as well as on the types and methods of trials that are included in its scope of accreditation and in respect of which the test laboratory (center) is applying.

 

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

29. If the authorized body decides to include the test laboratory (center) in the register of authorized organizations, information about the test laboratory (center) is 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 posted on the official website of the authorized body on the Internet.

 

30. In case of non-compliance of the test laboratory (center) with one of the criteria specified in paragraph 26 of these Rules and a decision to refuse to include the test laboratory (center) in the register of authorized organizations, the authorized body shall notify the test laboratory (center) of the reasons for the refusal in writing by handing over the notification personally against signature to its representative, or send it by registered mail with notification of delivery, or transmit it electronically via telecommunication channels or in the form of an electronic document signed with an electronic digital signature.

31. An appeal against the decision of the authorized body is carried out in accordance with the legislation of the Member State.

32. Storage, systematization and modification of information about authorized organizations, as well as protection against unauthorized access to it, are provided by authorized bodies.

33. The register of authorized organizations is published on the information portal of the Union.

34. In the event of a change in the information contained in the register of authorized organizations, the authorized organization shall, within 30 calendar days (in the event of a change in information on the accreditation status of the authorized organization in the national accreditation system of the Member State - within 15 working days), submit to the authorized body an application for making changes to the specified information, 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 the application for making changes to the information contained in the register of authorized organizations:

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

b) send the relevant information to the Commission using the means of the integrated information system of the Union (in the event that the authorized body decides to make changes), and may also post it on its official website on the Internet;

c) notify the authorized organization of the decision taken in writing by handing over the notification personally against signature to its representative, or send it by registered mail with notification of delivery, or transmit 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 test laboratory (center) or organization that includes the test 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) detection of violations of the procedure for conducting 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 shall, within 3 working days from the date of the decision to exclude information from the register of authorized organizations, ensure the submission of the 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 the updating of the register of authorized organizations.

39. Provision, upon request of interested parties, of information on authorized organizations is carried out by authorized bodies in accordance with the legislation of the Member States.

 

Appendix

to the Rules for Conducting

Trials  to Assess the

Biological Effects of Medical Devices

 

FORM

OF THE PROTOCOL OF TRIALS TO ASSESS THE BIOLOGICAL EFFECTS OF A MEDICAL DEVICE

 

___________________________________________________________

(name of the test laboratory (center))

___________________________________________________________

(information about the accreditation of the test laboratory (center): number, validity period of accreditation (accreditation certificate))

___________________________________________________________

(address and telephone number of the test laboratory (center))

Approved 

By the Head of the Test

Laboratory (Center)

 

_________ ____________________

(Signature) (Surname, Initials)

"" _______________ 20__ y.

(Date)

 

M.P. (Seal)

PROTOCOL

OF TRIALS TO ASSESS THE BIOLOGICAL EFFECTS OF A MEDICAL DEVICE

N _______

 

Information about the medical device:

_____________________________________________________________________________

(name, brand, model, catalog number (if available), intended use and scope of application)

 

Materials of the medical device and accessories thereto (if any) that come into contact with the human body:

_____________________________________________________________________________

Information about the sample(s) of the medical device:

_____________________________________________________________________________

(quantity, identification marks (brand, model, mass, volume, date of manufacture, expiration date (service life), catalog number, factory (serial) number (number of series, batch (lot)), etc. (if applicable)))

 

The 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 an individual entrepreneur)

 

_____________________________________________________________________________

(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 an individual entrepreneur)

 

Information about the production site(s):

_____________________________________________________________________________

(name - for a legal entity or surname, first name, patronymic (if any) - for an individual registered as an individual entrepreneur, address of the place of business)

 

Basis for conducting trials:

_____________________________________________________________________________

 

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

_____________________________________________________________________________

 

Standards to which the trials were carried out:

_____________________________________________________________________________

 

Methods (methodologies) of trials:

_____________________________________________________________________________

 

Place of conducting trials:

_____________________________________________________________________________

 

Date of commencement of  trials:

"" __________ 20__ y.

 

Date of completion of  trials:

"" __________ 20__ y.

 

Conclusion: the submitted samples of the medical device

_____________________________________________________________________________

(meet, do not meet the requirements - indicate the required)

 

Submitted documents:

_____________________________________________________________________________

(name, copy or original document - indicate the required, number of pages)

 

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

_____________________________________________________________________________

List of used measuring instruments, testing equipment:

_____________________________________________________________________________

 

Results of trials:

 

Table N _____

1 Indicating the unit of measurement, as well as the uncertainty of measurements (if applicable). The results must be clearly related to the sample of the medical device for which they were obtained.

2 Temperature, humidity, atmospheric pressure, etc.

Specialist of the test laboratory (center)

______________  ________________________

(Signature) (Surname, Initials)

 

Appendix. Photographic images of the general appearance of samples of the medical device with accessories necessary for its intended use (if any), and their marking.

 

Notes:

1. The following information must be indicated on the last page of the protocol:

"The results of trials relate only to samples of the medical device that have been tested.

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

2. The header of the protocol shall indicate information that ensures the unique identification of the protocol, the traceability of its components, as well as the end of the protocol.