The Decision of the Council of the Eurasian Economic Commission "On Amendments to the Requirements for the Implementation, Maintenance, and Evaluation of the Quality Management System for Medical Devices, Depending on the Potential Risk of Their Use" was published on the EAEU legal portal - https://docs.eaeunion.org/documents/461/10669/
The main change aims to eliminate the need for multiple assessments of the production conditions of a sterilization site used by different medical device manufacturers by establishing the possibility of recognizing the results of its assessment conducted earlier as part of the inspection of the production of any other medical device.
The condition for this relaxation is the availability of a valid inspection report for the medical device manufacturer, which includes information about the sterilization site.
This change will allow medical device manufacturers to reduce the cost and time of production inspections, while inspecting organizations will be able to use their resources more efficiently.
The Decision will enter into force on June 18, 2026.
The main change aims to eliminate the need for multiple assessments of the production conditions of a sterilization site used by different medical device manufacturers by establishing the possibility of recognizing the results of its assessment conducted earlier as part of the inspection of the production of any other medical device.
The condition for this relaxation is the availability of a valid inspection report for the medical device manufacturer, which includes information about the sterilization site.
This change will allow medical device manufacturers to reduce the cost and time of production inspections, while inspecting organizations will be able to use their resources more efficiently.
The Decision will enter into force on June 18, 2026.
