Quality management system for medical device manufacturers became mandatory in EAEU

In accordance with EAEU decision, quality management system inspections become a mandatory requirement. Manufacturers have to maintain quality management system in order to ensure sufficient quality and safety of medical devices they produce. Therefore, it is considered to be necessary to conduct mandatory inspections of the production sites, especially for high-risk medical products. These include, for example, sterile medical devices, implantable products and a number of other devices. On March 16, 2019, a transitional period, which allowed manufacturers to postpone inspections, ended. From now on quality management system inspections become mandatory. Schedules of inspections will be posted on the official websites of the authorized bodies in the Internet, as well as in the EAEU information portal. For low-risk medical device quality management system inspections are considered to be voluntary.


http://www.eurasiancommission.org/ru/nae/news/Pages/05−04−2019−1.aspx