New List of EAEU standards for medical devices published

The Commission the Eurasian Union published a list of 155  Standards that shall be applied for medical devices and 43 for IVD if imported to the union.


The list has been published as Recommendation No. 17 - Рекомендация Коллегии Евразийской экономической комиссии от 04.09.2017 N 17 and is available in Russian language.


The main table of the publication includes not only the name of the standard and its version but also a cross reference form the articles of the standards to the "General Requirements" "Пункт Общих требований" as published under Commission Decision No. 27 dated 12. February 2016.


As such it the analogy to the annexes Z in the European harmonized standards.


It is recommended to have a closer look to the list before applying for registration in the EAEU.