Changes in the rules for conducting technical tests within the EAEU framework
As you know, technical tests are one of the important stages before starting the registration procedure in the EAEU, which is regulated by the Decision of the Eurasian Economic Commission No. 28.
Currently, the draft decision is under public discussion and was published on the EAEU legal portal dated 09.07.2020. The updated document will enter into force after 180 calendar days from the date of its official publication.
As for the changes made, the draft decision differs significantly from the adopted document:
1. The general provisions of the document were amended with terms, reference documents within the EAEU framework.
2. An addition has been made to the rules for conducting technical tests in accordance with Paragraph 2, Clause 22. Technical tests shall be carried out by an authorized organization within a period not exceeding 30 working days from receiving the samples of medical devices in accordance with the agreed test program, subject to the applicant's payment for the services of an authorized organization in accordance with the concluded agreement. The term for conducting technical tests, in agreement with the applicant, can be extended by the head of the authorized organization, but for no more than 20 working days.
Clause 24. In the technical test report, the test methods (procedures) are specified for each determined indicator specifying the full identifying details of the relevant documents (for the methods described in the standards, the corresponding clauses of the standards are specified).
3. Paragraph 3 Requirements for authorized organizations and the procedure for assessing their compliance with these requirements was amended with the following items:
34. In the event of a change in the information contained in the register of authorized organizations, the authorized organization, no later than 30 calendar days from the date of these changes, shall have to submit an application to the authorized body for changing the information contained in the register of authorized organizations, as well as documents confirming the data changes.
35. The authorized body, within 10 working days after the authorized organization submits an application for changing the information contained in the register of authorized organizations:
а) shall consider the submitted application and documents and inform the authorized organization in writing on the decision taken;
b) shall ensure the placement of relevant information on its official websites in the information and telecommunications network “Internet”, as well as its submission to the Commission using the means of the integrated information system of the Union (if the authorized body makes a positive decision).
36. within 1 working day, the Commission shall ensure the updating of the register of authorized organizations.
37. Exclusion of authorized organizations from the register shall be carried out by the authorized body in the following cases:
а) filing an application signed by the head of the authorized organization on exclusion of authorized organizations from the register;
b) lack of information on accreditation of the authorized organization in the national accreditation system of the member state;
c) submission by a body authorized in accordance with the legislation of a member state, based on the results of state control (supervision), of information on a violation of mandatory requirements when an authorized organization conducts technical tests.
4., The form of the technical test report has also changed.
Based on the made changes and amendments, it should be noted that the new edition of the rules for conducting technical tests describes the procedures for testing a medical device and the criteria for inclusion in the unified register of authorized organizations entitled to conduct research of medical devices for registration within the Union in more detail. The terms of technical tests are regulated.
The presented changes significantly reduce the manufacturers’ financial costs when registering medical devices.
As a result, a manufacturer of a medical device has a more simplified access to the market for selling its product in the Union.