On April 27, 2026, the Council of the Eurasian Economic Commission (EEC) approved amendments to the Requirements for the Quality Management System of Medical Devices (approved by EEC Council Decision No. 106 of November 10, 2017). The main change is the elimination of the practice of multiple inspections of sterilization sites serving multiple manufacturers.
The essence of the innovation
Previously, every medical device manufacturer using the same sterilization facility was required to undergo a separate inspection. Now, a mechanism is being introduced to recognize the results of previous inspections.
Key terms
– The site inspection is carried out once as part of the registration of any medical device .
– To recognize the results, a current manufacturer’s inspection report is required, including information about the sterilization site in question.
Significance for market participants
medical device manufacturers: reduced costs and faster inspection procedures, especially for companies using contract sterilization. This eliminates the need for re-inspections of already certified facilities.
For inspection authorities: resource optimization: instead of multiple visits to one site, they concentrate on objects requiring primary inspection.
For healthcare systems in EAEU countries: acceleration of registration processes and reduction of administrative barriers, which increases the availability of medical devices.
The decision of April 27 continues the EAEU’s commitment to reducing regulatory burdens without compromising quality and safety.
Pharmaceutical companies with sterilizable medical devices in their portfolios should take into account that the availability of a valid inspection report from one manufacturer now expedites the procedure for others. This encourages cooperation and data exchange between market participants. Furthermore, the EEC decision is another signal of the Union’s transition to a model of mutual recognition of control results, which could potentially change the system for admitting medical devices to the common market.
