CMU prolonged the period of transition period on implementation of TR for medical devices

The text of the Resolution No 240 dated 23 March 2016 On amendments to the certain CMU Resolutions was published on the official page of the Government.

This document foresees the postponement of the implementation for three technical regalements on medical devices to 01.07.2017.

The transitional period provides the turnover on the market and/or putting into operation of medical devices on the basis of current available certificate of state registration. These devices can be present on the market without conformity assessment procedure and national assessment label till the end of expiry date not more than 5 years form the date of marketing access.

At the same time, the regulatory act provides the possibility to pass through the necessary procedure on conformity assessment during this period freely and voluntarily.