From January 1, 2022, all new medical devices entering the Eurasian Economic Union countries such as Russia, Belarus, Kazakhstan, Armenia, Kyrgyzstan, etc. must be registered according to the Union’s EAC MDR regulations. Then accept the application for a medical device registration certificate to a single country. Medical devices that have been registered in the Russian Federation can continue to be used, or the registered certificate can be modified until 2027.
EAC MDR Product Classification
According to different risk levels, EAC MDR can be divided into Class I, Class IIa, Class IIb, Class III, of which Class III has the highest risk level, similar to the European Union. The higher the risk level, the higher the registration procedures and requirements.
EAC MDR Certification Process
1. Determination of risk level and type of nomenclature to use 2. Determination of documentation checklist 3. Collection of evidence of safety and efficacy 4. Selection of reference status and identification status
5. Pay customs duties
6. Submit documents
7. Production inspection of medical devices, etc.
8. Approval Procedure
9. Medical device registration
EAC MDR Certification Information
The following information list is optional, depending on the risk level of the product to confirm whether it needs to be provided.
1. Apply in the form specified in Appendix
2 and 3 of the “Registration and Professional Rules for the Safety, Quality and Efficiency of Medical Devices”
3. The authorization letter representing the interests of the manufacturer when registering
4. A copy of the medical device manufacturer’s quality management system certificate (ISO 13485 or the relevant regional or national standards of the member states)
5. The medical device safety and effectiveness conformity declaration or equivalent document
6. The registration certificate issued by the country of manufacture ( Copy of certificate of free sale, export certificate (except for medical devices first produced in the territory of the Member State)) and translated into Russian
7. Copy of documents certifying registration in other countries
8. Medical device certificate stating the medical device Scope, use, brief characteristics, versions and accessories (forms)
9. Marking and packaging data (full-color layout of packaging and labels, marked text in Russian and official languages of member states)
10. Development and manufacturing information: manufacturing process drawings, Main manufacturing steps, packaging, testing and final product release procedures
11. Information about the manufacturer: name, type of activity, legal address, form of ownership, composition of management, list of departments and subsidiaries, and description of their status and powers
12. Incidents and Recall report (does not provide information on newly developed and designed medical devices): a list of adverse events or incidents associated with the use of the device, and an indication of the time period in which these events occurred, if there are too many adverse events, it may be necessary to Types of Incidents Provide a brief overview and indicate the total number of incidents reported for each type A list of comments and/or explanatory notices for the medical device market and a description of the incidents, methods to address them and the manufacturer’s in each case The solution describes the analysis and/or corrective actions to be taken in response to these situations 13. List of standards to which the medical device conforms (with relevant information)
14. General requirements, labelling requirements and Information required by operating documents (hereinafter referred to as – general requirements)
15. Documents establishing requirements for technical characteristics of medical devices 16. Reports of technical tests carried out to demonstrate compliance with general requirements
17. Protocols for studies (tests) to assess biological effects of medical devices, Aims to demonstrate compliance with general requirements
18. Clinical evidence reports on the efficacy and safety of medical devices
19. Risk analysis reports
20. Drug data in medical device ingredients (drug composition, quantity, drug and medical device compatibility data, Registration of the drug product in the country of manufacture)
21. Biosafety data
22. Sterilization procedure data, including process validation, microbiological test results (level of bioburden), pyrogenicity, sterility (if necessary), and test method instructions and packaging Information on validation data (sterile products)
23. Specific software information (if available): Manufacturer’s information on software validation
24. Stability study report – with authentic Russian translation of test results and conclusions for products with shelf life
25. Use in recognized countries Operating documents or instructions for the use of the medical device in the national language (if necessary) and in Russian
26. Service manuals (in the case of components of medical devices) – in the absence of data in operating documentation
27. Production inspection reports 28. Plans for collection and analysis of data on safety and efficacy of medical devices in the post-marketing phase