January 16, 2022
QMS for medical devices within the framework of the EAEU
From 2022, as part of MD registration according to the requirements of the EAEU, for products of risk classes 2a (sterile products), 2b and 3, production will be inspected for compliance to requirements of EAEU Council Decision No. 106.
According to this Decision, the quality management system for medical devices (MD QMS) is the organizational structure, functions, procedures, processes, and resources necessary for coordinated activities for the management of the organization - the manufacturer of medical devices in relation to quality.
As part of the MD QMS assessment implementation, maintenance, and effectiveness of the functioning of the MD QMS is confirmed, which ensures the compliance of the products released into circulation within the Union to the applicable General MD Safety and Effectiveness Requirements (Council Decision No. 27).
MD QMS assessment is carried out in the form of production inspection. According to Decision No. 106, inspection of production can be:
- Primary (carried out by the authorized body of the reference state at all manufacturing sites declared in the application form in the frame of the registration procedure). Based on the results of the inspection, a report is issued that is valid for 3 years from the date of its issue.
- Periodic (scheduled), which is held once every 3 years. The manufacturer has the right to apply to any inspection organization within 6 months before the expiration of the report on the results of the previous production inspection.
- Unscheduled. The manufacturer may initiate an unscheduled inspection in the following cases: changes in the list of manufacturing sites, in the list of groups (subgroups) of MD that are subject to report on the results of the inspection; confirmation of the elimination of violations based on the results of the inspection of production; confirmation of the elimination of the causes that led to the release of defective MD; confirmation of the introduction of MD QMS by the manufacturer.
When conducting a production inspection, the MD QMS is evaluated for the following processes:
ü design and development processes, if they are included in the MD QMS by the manufacturers;
ü documents and records management processes;
ü production and output control processes;
ü corrective and preventive action processes;
ü consumer-related processes.
If the manufacturer has implemented the MD QMS in accordance with the requirements of standards equivalent to the international standard ISO 13485, then evidence of compliance of the QMS with the requirements of these standards (certificate of conformity, audit reports of the MD QMS) ensure its compliance with the requirements of Decision No. 106 in terms of processes and procedures related to the functioning of the MD QMS. In this case, the inspection is limited to verifying compliance with the requirements related to the design, development, production and output control processes, consumer-related processes (in terms of postmarketing monitoring).
- Decision of the Council of the Eurasian Economic Commission of November 10, 2017 N 106 (as amended on November 12, 2021) “On the Requirements for the Implementation, Maintenance and Assessment of the Quality Management System of Medical Devices, Depending on the Potential risk of their use”
