EAEU Overview
What is the EAEU?
The Eurasian Economic Union (EAEU) is a customs and economic union of five states: Russia, Belarus, Kazakhstan, Armenia, and Kyrgyzstan. It operates a harmonised regulatory framework for medical devices — the EAEU Agreement on common principles and rules for the circulation of medical devices — governed by the Eurasian Economic Commission (EEC).
The key regulatory instrument for medical devices is EEC Decision No. 46, which establishes the rules for EAEU registration. A single EAEU Registration Certificate gives the right to place a device on the market in all five member states.
Why EAEU matters for Russia
- From 1 January 2027, Russia will only accept new medical device registrations under the EAEU pathway. The national (Decree No. 1684) route closes to new submissions.
- Manufacturers who register under the EAEU pathway now gain access to Russia and four additional markets with a single registration.
- Existing national registrations remain valid until expiry but cannot be renewed under national rules after 2027.
The EAC mark
Devices registered under the EAEU pathway must bear the EAC mark (Евразийское соответствие — Eurasian Conformity) on their labelling and packaging. The EAC mark signifies that the device complies with EAEU technical requirements and has been registered through the EAEU system.
EAEU database
The EEC maintains an EAEU database of registered medical devices, analogous to Russia's national GRLS. A device listed in the EAEU database may be placed on the market in any EAEU member state.
Eurasian Economic Commission: eec.eaeunion.org