The Council of the Eurasian Economic Commission (EEC) adopted a decision which amends the requirements to implementation, maintenance, and evaluation of a quality management system for medical devices (MI QMS) depending on the potential risk of their use.

The EEC Council permits to carry out the procedure for assessing the quality management system of medical devices remotely in this decision. However, a manufacturer must provide the following documents and information that can vary depending on whether the audit is initial or periodic:

1. Description of MI QMS depending on the potential risk of their use

2. Copies of production licenses

3. Information about the employees involved in the MI QMS processes

4. List of produced and planned for production medical devices

5. Technical files of medical devices

6. Copies of reports resulting from the QMS audit and inspection of production carried out by the certification body

7. Documents and records relating to processes of:

• QMS MI design and development (for class III of potential risk)
• MI QMS documentation and records management 
• production and final control of medical devices
• corrective and preventive actions of the MI QMS

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8. Documents and records that show an assessment of the MI QMS processes related to the consumer.

Please, note that in order to be able to conduct a remote MI QMS assessment, the manufacturer must confirm in advance the geolocation data (latitude, longitude) of the location of the production site.

The official text of the decision can be found here.

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The information has been prepared by the GMA Consult Group team.‍

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