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EEC amended List of Standards for Medical Devices
The Board of the Eurasian Economic Commission has amended the List of standards, which, when used on a voluntary basis, gets the General Requirements for Safety and Efficacy of Medical Devices, the Requirements for Their Labeling and relevant User Guides to be complied with by medical devices either in full or in part (Recommendation No. 17 of the Commission Board dated September 4, 2017).
The amendments suppose including information about 16 new versions of the standards adopted in 2020-2022, which had been previously included in the List. These are, for instance, a number of the GOST ISO 10993 standards “Medical devices. Evaluating the biological effect of medical devices”, GOST IEC 62304-2022 standard “Medical devices. Software Life Cycle Processes” and others, and having the standard, which has become invalid, excluded from the List.
The previously established deadline for applying the standards has also been excluded from the List. This is because these standards are still used in the Eurasian Economic Union Member States.
