The Decision adopted 26 July 2018 (in force as of 28 August 2018) provides criteria for determining how the type of a medical device constituent is to be identified.
EEU (Russia, Belarus, Kazakhstan, Armenia and Kyrgyzstan)
The Eurasian Economic Commission (EEC) has commenced work on creating a system that will allow the countries of the Eurasian Economic Union (EAEU) to exchange information on measures taken to prevent or limit the sale or use of products that pose a serious risk to the health and safety of consumers.
As of 1 October 2018, the amendments to the EAEU Technical Regulation on the Safety of Products for Children and Adolescents entered into force.
The amendments clarified the definition of a “type sample”. The previous version of the TR required one separate type sample for each age group, even though the products were made by one manufacturer from the same materials and according to the same technical documentation.
As of 18 July 2018, a revised regulation on conformity assessment modules (applied to certification, declaration and product registration) entered into force in the EAEU. The conformity assessment modules are to be applied by manufacturers, importers and persons authorised by manufacturers in order demonstrate product conformity with the requirements imposed by EAEU Technical Regulations.
EurAsian Economic Commission Collegiate adopted a Decision that lists products subject to the Technical Regulation on the Safety of Packaged Drinking Water, Including Natural Mineral Water (TR EAEU 044/2017). The Technical Regulation (TR) enters into force on 1 January 2019.
The Decision adopted by the EurAsian Economic Commission Collegiate sets that for 18 months from the date the GMO labelling requirement enters into force, products manufactured with the use of GMO but not complying with GMO labelling requirements may be manufactured and placed on the market.