The Recommendation of the EEC Board on conducting inspections of medical device production was adopted on April 7, 2026, in accordance with Article 31 of the EAEU Treaty dated May 29, 2014, and Article 3, paragraph 2, of the Agreement on Common Principles and Rules for the Circulation of Medical Devices within the EAEU dated December 23, 2014, and is published on the EAEU Legal Portal - https://docs.eaeunion.org/documents/462/10612/
The document forms a unified methodological basis for inspecting organizations in all EAEU member countries and approaches to conducting inspections, but it is of a recommendatory (non-mandatory) nature.
According to the text of the Recommendation, it is proposed to assess the quality management system of medical devices during inspections of production based on the following processes:
The content of the inspections is presented in the form of specific tasks, depending on the potential risk class of the medical device and the availability of a certified quality management system. Special attention is recommended to be paid to sterilization processes, as well as inspections of production facilities in case of notification of adverse events or complaints about the product.
Despite its recommendatory nature, the document effectively defines the standard for conducting inspections of medical device production throughout the Union.
The document forms a unified methodological basis for inspecting organizations in all EAEU member countries and approaches to conducting inspections, but it is of a recommendatory (non-mandatory) nature.
According to the text of the Recommendation, it is proposed to assess the quality management system of medical devices during inspections of production based on the following processes:
- design and development processes, if they are included in the quality management system of the medical device manufacturer;
- documentation and record management processes;
- production and output control processes;
- corrective and preventive action processes;
- consumer-related processes.
The content of the inspections is presented in the form of specific tasks, depending on the potential risk class of the medical device and the availability of a certified quality management system. Special attention is recommended to be paid to sterilization processes, as well as inspections of production facilities in case of notification of adverse events or complaints about the product.
Despite its recommendatory nature, the document effectively defines the standard for conducting inspections of medical device production throughout the Union.
