News

At its meeting on February 11, the Board of the Eurasian Economic Commission amended the list of standards, as a result of the application of which on a voluntary basis the Eurasian Economic Union countries fully or partially ensure compliance of medical products with the General Requirements for safety and efficiency of medical products, requirements for their marking and operational documentation for them.

The amendments provide for including information about new versions of three standards adopted in 2022–2023, which had been previously included in the list.

These are GOST R ISO 14155-2022 "Clinical investigation of medical devices for human subjects. Good clinical practice", GOST R ISO 15223-1-2023 "Medical products. Symbols to be used with information to be supplied by the manufacturer. Part 1: Basic requirements" and GOST R IEC 62366-1-2023 "Medical products. Part 1: Application of usability engineering to medical devices".