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EAEU Legal Instruments

The EAEU Agreement on medical devices​

The legal foundation for EAEU medical device regulation is the "Agreement on common principles and rules for the circulation of medical devices (medical equipment) within the Eurasian Economic Union", signed by the heads of state of EAEU member states. This Agreement delegates detailed rule-making to the Eurasian Economic Commission (EEC).

EEC Decision No. 46​

EEC Council Decision No. 46 is the primary EAEU instrument for medical device registration. It establishes:

  • The unified rules for registration of medical devices in EAEU member states
  • The content requirements for the EAEU registration dossier
  • The review and decision-making process
  • Requirements for the EAEU Registration Certificate

Decision No. 46 is directly applicable in all EAEU member states without requiring national transposition.

EEC Regulation No. 106 — QMS for EAEU​

EEC Regulation No. 106 establishes the QMS requirements for EAEU medical device registration. It specifies the requirements for manufacturing site inspections for Class IIb and III devices — making QMS inspections mandatory under the EAEU system since March 2019.

EAEU Agreement on common principles​

The broader EAEU Agreement on common principles of medical device circulation established the framework and transition timelines for EAEU harmonisation. A key provision is the closure of national registration routes, with Russia's national pathway closing from January 2027.

Where to access​

EAEU legal instruments are published by the Eurasian Economic Commission:

Official source

Eurasian Economic Commission: eec.eaeunion.org