On April 7, 2026, the Board of the Eurasian Economic Commission adopted Recommendation No. 6, which establishes unified principles for conducting inspections of medical device manufacturing sites in the Union’s member states. The document includes detailed assessment sheets (checklists) for inspectors and covers all significant elements of a quality management system (QMS), taking into account the potential risk class of the device.
Purpose of the recommendation
Ensure a coordinated approach to inspecting medical device manufacturing facilities within the EAEU in accordance with the QMS Requirements approved by Decision No. 106 of the EEC Council dated November 10, 2017. This recommendation is addressed to authorized bodies of the Union countries and organizations authorized to conduct inspections.
Five main areas of assessment
The inspection focus, according to paragraph 4 of the Recommendation, is on the following groups of QMS processes:
1. Design and development – risk management, verification, validation, transfer of design documentation to production.
2. Documentation and records management – identification, storage conditions, version and change control.
3. Production and final control – process control, validation, traceability, sterilization, cleanliness and infrastructure requirements.
4. Corrective and Preventive Actions (CAPA) – performance assessment, linkage to design and process changes.
5. Consumer-related processes – complaint handling, post-sales monitoring, safety notifications.
For each of the listed processes, the appendices to the document provide checklists containing 26 specific tasks with methodological tips for inspectors.
Significance for market participants
– Manufacturers receive predictable and uniform criteria for preparing for inspections in any of the EAEU countries.
– Checklists structure the assessment of critical suppliers (including sterilization, casting, and welding services) and the validation of manufacturing processes.
– Clarified requirements for post-market monitoring and CAPA contribute to improving the safety of products in circulation.
– For implantable medical devices, traceability requirements have been tightened at all stages of the life cycle.
