At its meeting held on September 23, the Eurasian Economic Commission's Board adopted the Methodological Recommendations on classifying medical products for in vitro diagnostics depending on the potential risk of use for the purposes of their registration within the Eurasian Economic Union.
This entails performing a wide range of laboratory tests, including hematologic, general clinical, genetic, immunologic, and microbiological tests, hemostasis testing, biochemical blood tests for infections, and others. These are necessary to better understand diseases and choose the most efficient ways to treat them.
In accordance with the Commission's Methodological Recommendations, medical products used in such studies may be assigned to different classes depending on the potential risk of use, which determine the requirements thereto.
The Recommendations contain explanations and examples to the Rules for classifying medical products depending on the potential risk of use, approved by the Commission's Board in 2015, and are aimed at forming uniform approaches in the Union countries to classifying medical products for in vitro diagnostics in accordance with these Rules. This will enable to raise the level of mutual recognition of the examination results of such products.