The Working Group uniting the expert community operating in the field of medical device circulation is an advisory and consultative body that ensures the preparation of recommendations and guidelines on issues related to medical device circulation within the territory of the Eurasian Economic Union, the development of unified approaches, the provision of consultations, and the organization of educational events.
The main tasks of the Working Group are:
- Discussion of issues related to disagreements that arise between the reference state and the recognition state(s) in connection with the coordination (approval) of the expert opinion on the assessment of safety, quality, and effectiveness during the registration of medical devices, in accordance with the Rules for the registration and expert examination of medical devices in terms of safety, quality, and effectiveness, approved by Decision No. 46 of the Council of the Eurasian Economic Commission dated February 12, 2016;
- Discussion of issues related to product type classification;
- Discussion of issues related to the classification of medical devices according to potential risk associated with their use;
- Preparation of recommendations on the improvement of documents that form part of Union law in the field of medical device circulation, with the aim of subsequently submitting them for consideration by the working group on the development of unified approaches to the regulation of medical device circulation within the Union.
The first founding workshop of the Working Group took place on June 21–25, 2025, at the initiative of the Federal Service for Surveillance in Healthcare of the Russian Federation and its subordinate expert center, the FSBI VNIIMT (ФГБУ «ВНИИИМТ» Росздравнадзора).
Ongoing sessions are held as needed, in accordance with an agenda formed based on issues collected for consideration.
During the Commission’s meetings, questions from the economic operators involved in the circulation of medical devices may also be considered, as necessary. Such issues may be submitted to the following email address: .
Minutes of the Working Group meetings, as well as guidelines developed by the Working Group, will be published on this platform.
