Biocompatibility studies

Biocompatibility studies are regulated by the Decision of the Council of the Eurasian Economic Commission dated May 16, 2016 No. 38 “On approval of the Rules for conducting studies (tests) in order to assess the biological effect of medical devices”, which were amended in 2022 by the Decision of the Council of the Eurasian Economic Commission dated March 17, 2022 No. 26 «On Amendments to the Rules for Conducting Studies (Testing) for the Purpose of Evaluating the Biological Effects of Medical Devices». The date of entry into force of the changes is September 14, 2022. The changes are quite extensive, including:

1. Changes have been made to the list of terms and definitions, most of the list has been removed (including the term “reference sample”), but at the same time several have been added – “MD category” (MD classification, depends on the group, type and duration of contact), “MD sample”, “MD standard sample”. This is probably due to the need to describe in biocompatibility studies the selection of MD samples, the safety of which can be extended to a certain category (group) of MD.
2. Clarified in which case the test results are considered negative.
3. Added clarification about the independence, impartiality and lack of pressure on the testing laboratory.
4. Changed the description of the composition of individual types of tests included in the studies.
5. The list of information and documents required to be submitted to the laboratory to assess the possibility of conducting studies has been expanded (detailed), including documents containing data on the labeling and packaging of a medical device, as well as a list of standards and methods of studies (tests)), certified (validated) and approved in accordance with the legislation of the Member State.
6. Provision of reference materials required for studies to the laboratory has been moved from the stage of application to the stage of testing.
7. The term for consideration of information and documents by the laboratory has been increased from 10 calendar days to 10 working days.
8. The paragraph about the possibility of an appeal by the applicant from the refusal to approve the application for studies has been removed, it has been replaced by the need for cooperation from the laboratory after the start of work.
9. In the process of concluding a contract between the applicant and the laboratory, additions were made on the need to determine the category of MD.
10. Sampling was previously possible only by the laboratory, now the sampling is carried out by the applicant or, on his behalf, by the laboratory.
11. Removed the possibility under certain conditions to conduct studies on the territory of the manufacturer.
12. Added the need to comply with the requirements established in the instructions for MD for samples at the stages of storage, transportation and preparation for studies.
13. Added the ability to conduct tests on standard samples (checking the safety of the MD group).
14. As components of the studies process, the stages of adjusting the studies program (if necessary) and identifying samples have been added.
15. The requirements for the need to test sterility, acute systemic toxicity, pyrogenicity, etc., the choice of methods for assessing biological effects under certain conditions or MD parameters have been removed.
16. Items about the determination by the laboratory in the process of researching the compliance of MD and documentation for MD with the requirements of standards and general requirements applicable to this type of testing have been removed.
17. A clarification has been added on the start of the countdown of the studies period, taking into account the payment for studies by the applicant.
18. A clause has been added on the need to indicate methods (links to methods) for each indicator under study in the protocols.
19. Changed the retention period for documents related to studies from “at least 10 years” to “the period established by the legislation of the Member State”.
20. From the criteria that the laboratory must meet, the requirements for the availability of satisfactory results of interlaboratory comparative tests (interlaboratory comparisons) were removed. Also the requirements for work experience for laboratory specialists (in the given field of studies or measurements) were reduced from 3 to 2 years.
21. Detailed processes for adding and deleting (including exclusion criteria) laboratories from the register of laboratories eligible to conduct studies, as well as processes for making changes to such information.
22. The form of the studies protocol has been detailed, including:
    1. added the need to specify information about:
       • MD materials;
       • type samples;
       • applicant;
       • manufacturer (more details);
       • manufacturing site;
       • grounds for testing;
       • samples selection;
       • standards against which the studies were conducted;
       • documents submitted for studies;
       • (if any) other studies provided by the applicant;
       • list of measuring instruments and equipment;
    2. a requirement has been added on the need to attach samples, accessories, markings to the protocol of photographic images of a general view.

Technical tests

Technical tests are regulated by the Decision of the Council of the Eurasian Economic Commission dated February 12, 2016 No. 28 “On Approval of the Rules for Technical Testing of Medical Devices”, it was amended in 2022 by the Decision of the Council of the Eurasian Economic Commission dated March 17, 2022 No. 25 “Decision of the Council of the Eurasian Economic commission dated March 17, 2022 No. 25”, the date of entry into force of this Decision is September 14, 2022. The changes are significant, including:

1. Added new terms and definitions, removed the definition of an authorized representative of the manufacturer.
2. Clarified who is responsible for the formation and maintenance of the register of laboratories.
3. Detailed (expanded) list of types of products for which technical tests are not carried out, namely: reagents, reagent kits, control materials, calibrators, washing solutions and nutrient media. Previously, «in vitro diagnostic devices (reagents, reagent kits) » were indicated.
4. Now it is allowed, in certain cases, to conduct field tests not only on the manufacturer’s territory, but also in places where the product is located and approved for use in accordance with the legislation of the relevant state (if such actions are permissible according to the quality management system of the laboratory).
5. Added clarification about the independence, impartiality and lack of pressure on the testing laboratory.
6. The list of information and documents required to be submitted to the laboratory to assess the possibility of conducting studies has been expanded (detailed), including the need to indicate test methods (methods) certified (validated) and approved in accordance with the legislation of the Member States. Added requirement to translate information and documents from foreign languages.
7. The term for consideration of information and documents by the laboratory has been increased from 10 calendar days to 10 working days.
8. The process of technical testing is detailed in two additional stages: the approval of the test program and (if necessary) the transfer of special equipment developed by the manufacturer, necessary for testing.
9. The test period is detailed – 30 working days, which, in agreement with the applicant, can be increased by 20 working days or another period, if this is provided for by the methodology.
10. A clause has been added on the need to indicate methods (links to methods) for each indicator under study in the protocols.
11. Changed the retention period for documents related to studies from «at least 10 years» to «the period established by the legislation of the Member State».
12. From the criteria that a laboratory must meet, the requirements for the availability of satisfactory results of interlaboratory comparative tests (interlaboratory comparisons) were removed. Also the requirements for work experience for laboratory specialists (in the given field of studies or measurements) were reduced from 3 to 2 years.
13. Detailed processes for adding and deleting (including exclusion criteria) laboratories from the register of laboratories eligible to conduct studies, as well as processes for making changes to such information.
14. The form of the studies protocol is detailed, including:
    1. removed the need to indicate the type of tests and record the extension of the results of type samples to homogeneous products;
    2. added the need to specify information about:
       • type samples;
       • manufacturing site;
       • samples selection;
       • place of testing;
       • documents submitted for the study;
       • (if any) other studies provided by the applicant;
       • list of measuring instruments and equipment.