Eurasian Union: New Recommendations and Drafts on Medical Devices

On 4 September 2017, the Eurasian Economic Commission published Recommendation No. 17, (link in Russian) ‘On the list of voluntary national standards that […] ensure conformity of a medical device with the Eurasian Essential Requirements for the Safety and Efficiency of Medical Devices’. The document harmonises existing national standards (155 voluntary standards for different types of medical devices) of the member states of the Eurasian Union and correlates them with the relevant requirements of the Essential Requirements.

Moreover, the Eurasian Commission published a number of drafts concerning medical device classifiers:

  • „Classifier of changes in the registration dossier of a medical device“ (link in Russian)
  • „Classifier of documents in the registration dossier of a medical device“ (link in Russian)
  • „Classifier of medical device area of usage“ (link in Russian).

The Eurasische Union consists of 5 member states: Russia, Belarus, Armenia, Kazakhstan, Kyrgyzystan.