At the meeting held on January 26, the Eurasian Economic Commission's Council adopted a new version of the Rules for conducting clinical and clinical laboratory tests (studies) of medical products, with due regard to the application experience and changes in international practice.

The updated version of the Rules specifies the conditions for recognizing the equivalence of medical products for the purposes of accepting test results, the procedure for obtaining permit to conduct tests, the requirements for conducting tests, the grounds for excluding medical organizations (clinical centers) from the unified register of authorized organizations entitled to conduct trials of medical products for the purposes of their registration, and the forms of test reports. The conditions for obtaining clinical data for software which is a medical product and the requirements to the technical file of such products are specified.

The amendments shall come into effect after 180 calendar days have elapsed from the date of their official publication. Along with that, a mechanism has been established to ensure a smooth transition to applying the amended version of the Rules. In order to maintain the process continuity, the possibility is provided to conduct clinical and clinical laboratory tests in accordance with the version in force at the time of the contract with the medical organization. Test reports issued according to the forms in force at the time of the contract with the medical organization shall be accepted for the medical product registration under the Union's law.