The EAEU countries have signed a Protocol that amends the agreement concerning the list of medical devices that do not require registration in the Union.
The new changes affect several categories of medical products:
- products manufactured to individual patient orders exclusively for their personal use;
- products imported for providing medical assistance based on the life indications of a specific patient;
- products manufactured in EAEU countries for the purpose of export to third countries.
In addition, the changes pertain to sets, kits, and first aid kits that are formed from registered medical devices and medicines and are intended for circulation within the territory of a specific state.
The Protocol will temporarily come into effect on February 19, 2026. The final entry into force will occur after the Commission receives the last written notification of the completion of the necessary domestic procedures by the member states.
