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15 Aug 2025 EIC Approved Concept for Developing Common Market of Medical Devices within EAEU On August 15 in Cholpon-Ata, the Eurasian Intergovernmental Council approved the Concept for Developing a Common Market of Medical Devices within the Eurasian Economic Union. The document is developed by the Eurasian Economic Commission jointly with the EAEU countries to ensure sustainable functioning of a common market of medical devices. The Concept is aimed at further improving the Union law in this field, harmonizing the Commission's acts with the documents of the International Medical Device Regulators Forum (IMDRF), including on their circulation using artificial intelligence technologies. The document is also designed to facilitate developing of digital processes in medical device authorization and circulation for the purpose of simplifying business processes in the Union countries. The Concept reflects the state of the said market, the current level of integration and harmonization of the Union law in the field of medical device circulation and approaches to developing uniform circulation rules in the light of IMDRF recommendations. Also, main outcomes of common market functioning and promising areas of its regulation were captured. The Concept draws special attention to safety of materials from which medical devices are made, as well as advisability of establishing approaches to applying additive technologies in the field of medical device circulation and standardization in the Union law. Interaction of the Member States to harmonize requirements to assessing medical devices will continue. It is planned to expand consultations on the Union law in the field of medical device circulation with interested third countries.
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