The legal portal of the Eurasian Economic Union published the Decision of the Board of the Eurasian Economic Commission (EEC) “On Approval of Requirements for Implementation, Maintenance and Assessment of Quality Management System for Medical Devices Based on Potential Risk of Their Use.”
The document takes effect 10 calendar days following its publication, that is, from March 15, 2018.
According to the document, in order to implement the quality management system for medical devices, the manufacturer of medical devices must:
- Elaborate documented requirements for risk management at all stages of the life cycle of medical devices
- Define the processes required for effective functioning of the quality management system for medical devices, and implement these processes at the medical devices manufacturing site.
- Define the sequence and relationship of processes
- Define criteria and methods required to ensure the effectiveness both in the implementation and management of processes
- Ensure conditions for manufacturing, resources and information required to maintain and monitor the processes
- Monitor, measure (where applicable), and analyze the processes
- Adopt measures required to achieve expected outcomes and maintain the effectiveness of processes.