Regulation of the Eurasian Economic Union

PROTOCOL

to amend the Agreement on Common Principles and Rules for the Circulation of Medical Devices (Medical Accessories and Medical Equipment) within the Eurasian Economic Union dated December 23, 2014

Member States of the Eurasian Economic Union, hereinafter referred to as the Member States,

based on the Treaty on the Eurasian Economic Union of May 29, 2014,

have agreed as follows:

Article 1

Article 11 of the Agreement on Common Principles and Rules for the Circulation of Medical Devices (Medical Accessories and Medical Equipment) within the Eurasian Economic Union dated December 23, 2014 shall be amended to read as follows:

“Article 11
Transition Period

Until December 31, 2021, an application for evaluation or marketing authorization of a medical device may be filed according to the procedure envisaged by the laws of a Member State. If an application for evaluation or marketing authorization of a medical device is filed according to the procedure envisaged by the laws of a Member State until December 31, 2021, the medical device may be registered according to the procedure envisaged by the laws of the Member State.

A medical device that has been registered according to the procedure envisaged by the laws of a Member State shall be
released into circulation in the territory of such Member State until the documents confirming its registration expire and shall circulate solely in the territory of such Member State.

A medical device that has been registered according to the procedure envisaged by the laws of a Member State
(save for medical devices, for which marketing authorization documents of unlimited validity have been issued) may be re-registered (marketing authorization documents shall be re-issued) according to the procedure envisaged by the laws of a Member State provided that an appropriate application is filed until December 31, 2026.

Marketing authorization documents for a medical device that has been registered according to the procedure envisaged by the laws of a Member State may be amended (save for amendments requiring new registration as per Clause 2 of Article 4 of this Agreement) provided that an appropriate application is filed until December 31, 2026.”.

Article 2

This Protocol shall come into force as from the date the depositary receives through its diplomatic channels a written confirmation of implementation by the Member States of internal national procedures as are required to be carried out for this Protocol to come into force.

Done in (city) _________ on ___ __________ 202__, in one original counterpart in Russian.

The original counterpart of this Protocol shall be deposited at the Eurasian Economic Commission, which, being the depositary of this Protocol, shall communicate a certified copy hereof to each Member State.