Council of the Eurasian Economic Commission Decision No. 106

Decision of the Council of the Eurasian Economic Commission

of November 10, 2017, No. 106

"On the Requirements for the Implementation, Maintenance, and Assessment of the Quality Management System for Medical Devices Based on the Potential Risk of Their Application"

(As amended by Decisions of the Council of the Eurasian Economic Commission

of November 12, 2021, No. 131, and August 19, 2022, No. 133)

 

In accordance with paragraph 2 of Article 31 of the Treaty on the Eurasian Economic Union of May 29, 2014, paragraph 1 of Article 6 of the Agreement on Common Principles and Rules for the Circulation of Medical Devices (Medical Products and Medical Equipment) within the Eurasian Economic Union of December 23, 2014, paragraph 107 of Annex No. 1 to the Rules of Procedure of the Eurasian Economic Commission, approved by Decision No. 98 of the Supreme Eurasian Economic Council of December 23, 2014, and in order to implement Decision No. 109 of the Supreme Eurasian Economic Council of December 23, 2014, "On the Implementation of the Agreement on Common Principles and Rules for the Circulation of Medical Devices (Medical Products and Medical Equipment) within the Eurasian Economic Union," the Council of the Eurasian Economic Commission decided:

1. To approve the attached Requirements for the Implementation, Maintenance, and Assessment of the Quality Management System for Medical Devices Based on the Potential Risk of Their Application (hereinafter referred to as the "Requirements").

2. To establish that:

a) Within 12 months from the date of entry into force of this Decision:

The assessment of the quality management system of the legal manufacturer of medical devices for compliance with the Requirements shall not be carried out;

When submitting an application for registration of a medical device of potential risk class 2a (for medical devices manufactured in sterile form), 2b, or 3, the registration dossier shall include documents confirming that the medical device manufacturer has production conditions for the medical device submitted for registration that comply with the requirements of the legislation of the Member State of the Eurasian Economic Union to whose authorized body the specified application is submitted (if such requirements exist), and copies of certificates of conformity of the quality management system to the requirements of GOST ISO 13485 "Medical devices. Quality management systems. System requirements for regulatory purposes" or the corresponding national (state) or international standard, as well as copies of reports on previously conducted factory audits for compliance with the ISO 13485 standard (if any);

 

b) The legal manufacturer of medical devices registered within 12 months from the date of entry into force of this Decision in accordance with the Rules for Registration and Examination of Safety, Quality, and Effectiveness of Medical Devices, approved by Decision No. 46 of the Council of the Eurasian Economic Commission of February 12, 2016, must confirm the implementation of the quality management system by undergoing an unscheduled factory audit in accordance with the Requirements within 2 years from the date of registration of the medical device; 

c) Paragraphs three and four of point 3 of the Requirements shall enter into force on the date of entry into force of the provisions on the introduction of relevant amendments to the Rules for Registration and Examination of Safety, Quality, and Effectiveness of Medical Devices, approved by Decision No. 46 of the Council of the Eurasian Economic Commission of February 12, 2016.

 

3. Granting powers to inspecting organizations to conduct factory audits of the legal manufacturer of medical device shall be carried out by the state authority of the Member State of the Eurasian Economic Union authorized to carry out and (or) coordinate activities in the field of circulation of medical devices in the territory of that state, in accordance with the requirements for such organizations, approved by the Eurasian Economic Commission.

4. This Decision shall enter into force upon the expiration of 10 calendar days from the date of its official publication.

 

Members of the Council of the Eurasian Economic Commission:

 

From the Republic of Armenia

V. Gabrielyan

 

From the Republic of Belarus

V. Matyushevsky

 

From the Republic of Kazakhstan

A. Mamin

 

From the Kyrgyz Republic

T. Abdygulov

 

From the Russian Federation

I. Shuvalov

Approved

By Decision of the Council

of the Eurasian Economic Commission

of November 10, 2017, No. 106

 

REQUIREMENTS

FOR THE IMPLEMENTATION, MAINTENANCE, AND ASSESSMENT

OF THE QUALITY MANAGEMENT SYSTEM FOR MEDICAL DEVICES

BASED ON THE POTENTIAL RISK OF THEIR APPLICATION

 

(As amended by Decisions of the Council of the Eurasian Economic Commission

of November 12, 2021, No. 131, and August 19, 2022, No. 133)

 

1. General Provisions

 

1. These Requirements have been developed in accordance with paragraph 2 of Article 31 of the Treaty on the Eurasian Economic Union of May 29, 2014, and paragraph 1 of Article 6 of the Agreement on Common Principles and Rules for the Circulation of Medical Devices (Medical Products and Medical Equipment) within the Eurasian Economic Union of December 23, 2014, and establish, within the framework of the Eurasian Economic Union (hereinafter referred to as the "Union"), requirements for the implementation, maintenance, and assessment of the quality management system for medical devices based on the potential risk of their application.

2. For the purposes of these Requirements, the following terms are used with the following meanings:

"Factory audit" - an assessment of the production conditions and quality management system of the legal manufacturer of medical device for compliance with these Requirements;

"Inspecting organization" - an authorized body or organization under the jurisdiction (subordination) of the authorized body and empowered to conduct factory audits of medical devices;

"Corrective action" - an action taken by the medical device manufacturer to eliminate the cause of a detected non-conformity or undesirable event;

"Correction" - an action taken to eliminate a detected non-conformity;

"Critical supplier" - a supplier whose products or services have a direct impact on the safety and (or) effectiveness of the medical device;

"Substandard medical device" - a medical device that does not comply with the general safety and performance requirements for medical devices, the requirements for their labeling, technical and operational documentation, and cannot be safely used for the intended purpose established by the manufacturer;

"Assessment of the quality management system of a medical device" - confirmation of the implementation, maintenance, and effectiveness of the functioning of the quality management system of medical devices to ensure compliance of medical devices placed on the market within the Union with the applicable General Safety and Performance Requirements for Medical Devices, the requirements for their labeling, technical and operational documentation, approved by Decision No. 27 of the Council of the Eurasian Economic Commission of February 12, 2016;

"Post-market surveillance" - a system for collecting and analyzing data from the medical device manufacturer on the use of medical devices, tracking, and identifying adverse events of medical devices during their operation;

"Preventive action" - an action taken to eliminate the cause of a potential non-conformity or potentially undesirable situation;

"Production site" - a territorially separated complex intended for performing the entire process of manufacturing a medical device or its certain stages;

"Quality management system for medical devices" - the organizational structure, functions, procedures, processes, and resources necessary for coordinated activities to guide and manage the organization - medical device manufacturer - in relation to quality;

"Authorized body" - a state authority of the Member State of the Union authorized to carry out and (or) coordinate activities in the field of circulation of medical devices in the territory of that state;

"Production conditions" - the infrastructure and production environment necessary to ensure compliance of manufactured medical devices with the General Requirements for Performance and Safety, requirements for their labeling, technical and operational documentation, approved by Decision No. 27 of the Council of the Eurasian Economic Commission of February 12, 2016.

 

II. Requirements for the Quality Management System for Medical Devices Based on the Potential Risk of Their Application

3. The legal manufacturer of medical device (with the exception of manufacturers of medical devices of potential risk class 1 and non-sterile medical devices of potential risk class 2a) shall, prior to submitting documents for registration of medical devices, implement a quality management system for medical devices based on the class of potential risk of their application.

The legal manufacturer of medical device of potential risk class 1 and non-sterile medical devices of potential risk class 2a have the right to implement and maintain a quality management system for medical devices.

Paragraph 3 shall enter into force in accordance with subparagraph "c" of paragraph 2.

 If The legal manufacturer of medical device of potential risk class 1 and non-sterile medical devices of potential risk class 2a have undergone an assessment of the quality management system of a medical device, including design and development processes, in accordance with these Requirements, then, during the validity period of the conclusion contained in the facroty audit report, amendments to the registration dossier of such medical devices shall be made without conducting an examination of safety, quality and effectiveness in a notification procedure.

Paragraph 4 shall enter into force in accordance with subparagraph "c" of paragraph 2.

The legal manufacturer of medical device shall, within 2 months from the date of making amendments to the documents of the registration dossier submitted for registration of the medical device, notify the authorized body that issued the registration certificate of the medical device of the relevant amendments in the form in accordance with Annex No. 7 to the Rules for Registration and Examination of Safety, Quality and Effectiveness of Medical Devices, approved by Decision No. 46 of the Council of the Eurasian Economic Commission of February 12, 2016.

 

4. The legal manufacturer of medical device of potential risk classes 2a (for medical devices manufactured in sterile form) and 2b shall, prior to submitting documents for registration of medical devices, implement a quality management system for medical devices (excluding the implementation of design and development processes).

5. The legal manufacturer of medical device of potential risk class 3 shall, prior to submitting documents for registration of medical devices, implement a quality management system for medical devices, including design and development processes.

6. The quality management system for medical devices shall ensure compliance of medical devices placed on the market within the Union with the applicable General Requirements for Safety and Effectiveness of Medical Devices, requirements for their labeling, technical and operational documentation, approved by Decision No. 27 of the Council of the Eurasian Economic Commission of February 12, 2016 (hereinafter referred to as the "General Requirements for Safety and Effectiveness").

7. To implement the quality management system for medical devices, the legal manufacturer of medical device shall:

a) develop documented requirements for risk management at all stages of the life cycle of medical devices;

b) identify the processes necessary for the effective functioning of the quality management system for medical devices (hereinafter referred to as "processes") and the application of processes in the medical device manufacturing organization;

c) determine the sequence and interrelation of processes;

d) determine the criteria and methods necessary to ensure effectiveness, both in the implementation of processes and in the management of processes;

e) ensure the availability of production conditions, resources, and information necessary to support the processes and to monitor the processes;

f) monitor, measure (where applicable), and analyze processes;

g) take measures necessary to achieve planned results and maintain the effectiveness of processes.

 

8. All elements of the quality management system for medical devices (organizational structure, methods, and process descriptions) shall be documented and kept up-to-date.

Documentation of the quality management system for medical devices shall be executed on paper, and if the legislation of the Member State of the Union (hereinafter referred to as the "Member State") provides for the possibility of executing the specified documentation in electronic form, on electronic media. Such documentation shall be submitted in Russian or with an authentic translation into Russian certified by the manufacturer in accordance with the procedure established by the legislation of the Member State.

 

9. The documentation of the quality management system for a medical device shall include, inter alia, a description of:

a) requirements for the technical characteristics of the medical device, standards or individual sections (clauses, subclauses) of standards that will be applied, and if the relevant standards will not be applied, the methods that will be used to ensure that the General Safety and Performance Requirements applicable to the manufactured medical devices are complied with;

b) the methods and depth of control by a third party if the design, production, and (or) final factory audit are performed by a third party;

c) the processes for the production, quality control, and quality assurance of the medical device, the processes, and systematic measures that will be used to control the quality and ensure the quality of the medical device, including corrective and preventive action processes;

d) documents recording the quality indicators of the medical device (reports on internal audits, factory audits, test results, and other documents);

e) means of controlling the achievement of the required quality of the medical device and the effective functioning of the quality system of the medical device;

f) plans, procedures, and documents for feedback from consumers (including monitoring the safety and effectiveness of the medical device in the post-market phase).

 

10. The legal manufacturer medical device who has implemented a quality management system for medical devices in accordance with these Requirements shall maintain it up-to-date and ensure its effectiveness.

 

III. Requirements for the Assessment of the Quality Management System for Medical Devices

11. The assessment of the quality management system for medical devices shall be carried out by inspecting organizations in the form of factory audit.

12. The costs associated with conducting factory audit as part of the assessment of the quality management system for medical devices shall be borne by the legal manufacturer of medical device based on an agreement concluded with the inspecting organization. Tariffs for conducting factory audits shall be established in accordance with the legislation of the Member States.

The calculation of the standard duration of a  factory audit shall be carried out according to the rules in accordance with Annex No. 1.

 

13. The inspecting organization shall not be interested in the results of the factory audit.

The inspecting organization, its management, and employees involved in conducting the factory audit shall not participate in activities that may affect the independence of their judgment or their impartiality with respect to the results of the factory audit, nor shall they be developers, manufacturers, suppliers of medical devices, shall not carry out maintenance (repair) of medical devices that they assess, or shall not be authorized representatives of the developer, manufacturer, supplier of medical devices, or persons performing maintenance (repair) of medical devices.

 

14. The inspecting organization shall document processes covering:

 a) processing requests from the medical device manufacturer for conducting a factory audit;

b) planning, conducting, and preparing a report on the factory audit;

c) the terms of the agreement on conducting a factory audit concluded with the medical device manufacturer or its authorized representative;

d) identifying the production sites that will be subject to factory audit;

e) preparing reports with a conclusion on the conformity or non-conformity of the quality management system for medical devices with these Requirements;

f) monitoring corrective actions to address non-conformities identified during the factory audit;

g) assigning responsibilities and powers to members of the inspection team during the factory audit (taking into account their competence) and, if necessary, engaging external experts.

 

15. The inspecting organization shall develop and implement procedures for the initial determination of the competence of inspectors when they are appointed to positions and for continuously maintaining its level.

Inspectors shall have a diploma of higher education with specialization in medicine, natural sciences, or engineering, at least 3 years of work experience in the field of assessing the safety, quality, and effectiveness of medical devices and (or) state control over the circulation of medical devices, and shall also possess:

knowledge of the production processes and technologies used by the legal manufacturer of medical device;

knowledge of the performance and safety requirements for medical devices, the technologies and risks of their medical application;

knowledge of the standards for quality management systems for medical devices and medical device risk management systems;

knowledge of the fundamentals of probability theory and statistics (including methods for determining confidence levels for representative samples and regression analysis).

 

The competence of inspectors, indicated in paragraphs three and four of this point, must be confirmed for subgroups of medical devices according to the list in Annex No. 2. The inspecting organization shall document the areas of competence of its inspectors. Records of the areas of competence of inspectors shall be kept up-to-date and taken into account when assigning inspectors to conduct factory audit of the relevant medical devices.

The inspecting organization shall verify the professional level of inspectors to confirm their competence by conducting certification and subsequent re-certification at least once every 3 years.

 

16. The inspecting organization shall implement a documented procedure for ensuring the confidentiality of information constituting commercial secrets and obtained during factory audits, taking into account the possibility of engaging external experts and the participation of inspectors (experts) from authorized bodies.

The confidentiality agreement concluded between the inspecting organization and the medical device manufacturer shall contain provisions allowing the submission of materials on the results of the facroty audit to the authorized body, as well as to any other authorized bodies between which there are confidentiality agreements.

 

17. The inspecting organization shall maintain in working order and store for at least 10 years records of factory audits and other activities for all legal manufacturers of legal devices who have applied for a factory audit and (or) have undergone a factory audit, which shall include:

a) information on the application and reports on the results of the facroty audit;

b) the agreement for conducting the factory audit;

c) justification for the duration of the facroty audit;

d) monitoring the implementation of corrective actions based on the results of factory audit;

e) records of complaints and appeals, as well as subsequent corrective actions;

f) documents confirming the competence of inspectors and external experts.

 

18. Authorization of inspecting organizations to conduct factory audit of the legal manufacturer of medical device, except in cases where the inspecting organizations are authorized bodies, shall be carried out by the authorized body for each subgroup of medical devices according to the list in accordance with Annex No. 2 to these Requirements based on an assessment of their compliance with these Requirements.

The authorized body shall have the right to determine the number of inspecting organizations for conducting factory audit upon application from medical device manufacturers and (or) in accordance with factory audit schedules within a period not exceeding 3 months from the date of submission by the medical device manufacturer of a complete set of documentation, including documents on payment for conducting the factory audit.

The list of inspecting organizations shall be posted on the websites of authorized bodies in the information and telecommunications network "Internet" (hereinafter referred to as the "Internet"), and shall also be published on the information portal of the Union.

Within 3 working days from the date of making changes to the information contained in the list of inspecting organizations, authorized bodies shall ensure that the relevant information is posted on their official websites on the Internet and submitted to the Eurasian Economic Commission using the means of the integrated information system of the Union.

 

19. The authorized body shall, at least once every 2 years, conduct a factory audit of inspecting organizations, except in cases where the inspecting organizations are authorized bodies, to verify compliance with these Requirements. Authorized bodies shall, no later than 3 months before the start of the factory audit, post on their official websites on the Internet schedules for facroty audits of inspecting organizations, which shall be accessible to inspecting organizations and authorized bodies.

If the inspecting organization is an authorized body, control over its activities shall be carried out in accordance with the procedure established by the legislation of the Member State.

The powers of an inspecting organization may be revoked by the authorized body if, based on the results of the factory audit, it is established that the inspecting organization does not comply with these Requirements.

Authorized bodies shall have the right, at their own expense, to send their representatives to participate in the factory audit of the inspecting organization as inspectors (experts), except in cases where the inspecting organizations are authorized bodies. Based on the results of the factory audit, the inspector (expert) shall have the right to submit written comments and proposals to the authorized body conducting the factory audit.

 

20. Within the framework of coordinating work in the field of administering factory audits and developing mechanisms for mutual peer review, authorized bodies shall have the right, at their own expense, to send their inspectors (experts) to participate in the conduct of factory audits as part of the assessment of the quality management system for medical devices. The legal manufacturer of medical device shall provide access to the inspection sites for members of the inspection (expert) team.

21. Reports on the results of factory audit shall be sent by the inspecting organization to the authorized body for inclusion in the registration dossier by registered mail with acknowledgment of receipt or in the form of an electronic document signed with an electronic signature within 15 working days from the date of completion of the factory audit.

22. The inspecting organization conducting the factory audit shall not issue a positive conclusion if the quality management system for medical devices does not comply with these Requirements or is not kept up to date.

The integral assessment of the significance of non-conformities of the quality management system for medical devices with these Requirements identified during the  factory audit shall be carried out in accordance with Annex No. 3.

Non-conformities identified as a result of the factory audit shall be eliminated by the legal manufacturer of medical device during the factory audit or within a period not exceeding 30 working days from the date of completion of the factory audit.

 

23. If the legal manufacturer medical device does not agree with the negative conclusion or the identified non-conformities, it shall send a claim to the inspecting organization within 30 working days from the date the inspecting organization receives a copy of the factory audit report. The inspecting organization shall review the claim and send a response within 15 working days from the date of its receipt. If agreement is not reached, the legal manufacturer of medical device has the right to appeal to the court at the location of the inspecting organization or to the authorized body that authorized the organization to conduct assessments of quality management systems for medical devices. If the legal manufacturer of medical device does not agree with the decision of the authorized body, it has the right to appeal this decision in court at the location of the authorized body.

If the legal manufacturer of medical device does not eliminate the remarks or violates the deadlines for eliminating them, the inspecting organization shall inform the authorized body that authorized the organization to conduct assessments of quality management systems for medical devices.

Until the legal manufacturer of medical device eliminates the remarks contained in the factory audit report, the authorized body has the right to suspend the release of the medical device into circulation in the territory of the Member State in accordance with the legislation of that State. In this case, the authorized body shall inform the authorized bodies of other Member States about the suspension of the release of the medical device into circulation in the territory of the Member State using the means of the integrated information system of the Union.

 

24. During the factory audit, an assessment of the quality management system for medical devices shall be carried out for the following processes:

design and development processes, if they are included in the quality management system of the legal manufacturer of medical device;

documentation and records management processes;

production and final factory audit processes;

corrective and preventive action processes;

processes related to the consumer.

 

If the legal manufacturer of medical device has implemented a quality management system for medical devices in accordance with the requirements of standards equivalent to the international standard ISO 13485, then evidence of compliance of the quality management system with the requirements of these standards (certificate of conformity, audit reports of the quality management system for medical devices) ensures its compliance with these Requirements in terms of processes and procedures related to the functioning of the quality management system for medical devices. In this case, the factory audit is limited to verifying the fulfillment of the requirements relating to the processes of design, development, production and final factory audit of the medical device and to the processes related to the consumer (in terms of post-market surveillance).

 

25. The assessment of the design and development processes of the quality management system for medical devices includes:

a) confirmation of the availability of design and development procedures (including risk management);

b) analysis of documents describing the design procedure and covering the model range of the medical device;

c) confirmation, based on selected design records for the medical device, that design and development procedures have been established and applied;

d) confirmation that the input data for the design process have been developed taking into account the purpose of the medical device and the relevant provisions of the General Safety and Performance Requirements;

e) analysis of the specifications for medical devices in order to confirm that the output data of the medical device design, ensuring the safety and effectiveness of the medical device when used as intended, have been determined;

f) confirmation that risk management activities have been identified and carried out, risk acceptance criteria have been established and are appropriate, any residual risk has been assessed and, if necessary, brought to the attention of the consumer in accordance with the General Safety and Performance Requirements.

 

26. The assessment of the documentation and records management processes of the quality management system for medical devices includes:

a) confirmation that procedures for the identification, storage, and disposal (destruction) of documents and records (including change control) have been developed;

b) confirmation of the availability of documents necessary for the organization to ensure the planning, implementation, and management of production processes;

c) confirmation that the documentation for the medical device includes:

evidence of compliance of medical devices with requirements (including the requirements of applicable standards);

a description of medical devices, including instructions for use, materials, and specifications;

summary documentation on verification and validation of projects (including clinical study (testing) data in accordance with the Rules for Conducting Clinical and Clinical Laboratory Testing (Research) of Medical Devices, approved by Decision No. 29 of the Council of the Eurasian Economic Commission of February 12, 2016);

medical device labeling;

risk management documents.

 

27. The assessment of the production and final factory audit processes of medical devices includes:

a) analysis of the production processes for the manufacture of serial products (including production conditions);

b) assessment of sterilization processes (for medical devices manufactured in sterile form), including:

determining that sterilization processes have been documented and records of sterilization process parameters for each sterilized batch of medical devices are maintained in working order;

determining that the sterilization process has been validated;

determining that the sterilization process is carried out in accordance with established parameters;

 

c) confirmation that production processes are managed and controlled and function within established limits, as well as confirmation of ensuring the necessary level of control of products and (or) services of critical suppliers;

d) confirmation of the identification and traceability of medical devices and their production processes, as well as their compliance with established requirements;

e) confirmation that final factory audit activities for medical devices ensure compliance of medical devices with established requirements and have been documented.

 

28. The assessment of corrective and preventive action processes of the quality management system for medical devices includes:

a) confirmation that procedures for corrective and preventive actions have been developed;

b) confirmation that controls prevent the distribution of medical devices whose quality does not comply with the General Safety and Performance Requirements for Medical Devices;

c) confirmation that corrective and preventive actions are effective;

d) confirmation that the legal manufacturer of medical device has developed an effective procedure for issuing and using medical device safety notices in accordance with the Rules for Monitoring the Safety, Quality and Effectiveness of Medical Devices, approved by Decision No. 174 of the Board of the Eurasian Economic Commission of December 22, 2015 (hereinafter referred to as the "Rules for Monitoring the Safety, Quality and Effectiveness of Medical Devices").

 

29. The assessment of consumer-related processes of the quality management system for medical devices includes:

a) confirmation that the legal manufacturer of medical device has taken the measures necessary to establish contact with consumers in order to carry out the necessary corrective and preventive actions, has a system for collecting and analyzing data on the safety and effectiveness of medical devices in the post-market phase and maintains it up to date, and also sends reports on the results of post-market monitoring of the safety and effectiveness of medical devices to the authorized body in accordance with the Rules for Monitoring the Safety, Quality and Effectiveness of Medical Devices;

b) confirmation that feedback from consumers is analyzed by the legal manufacturer of medical device during product lifecycle processes and is used to reassess risk and, if necessary, to update risk management activities.

 

30. The assessment of the quality management system for medical devices is carried out in the forms of initial, periodic (planned) and unscheduled factory audits.

31. The initial factory audit is carried out during the procedure for registering a medical device within the Union.

32. When conducting the initial factory audit, the inspecting organization conducts tha facrory audit of all production sites declared by the legal manufacturer of medical device.

If medical devices belonging to several groups (subgroups) of medical devices according to the list in accordance with Annex No. 2 to these Requirements, depending on the class of potential risk of their application, are manufactured at one production site, the facroty audit within one factory audit may cover several groups (subgroups) of medical devices in accordance with the production sites declared by the legal manufacturer of medical device.

 

33. Based on the results of the initial factory audit, the inspecting organization shall prepare a report in the form according to Annex No. 4. This report is valid for 3 years from the date of its issue.

34. The results of the factory audit shall apply to the group (subgroup) of medical devices according to the list in accordance with Annex No. 2 to these Requirements, depending on the class of potential risk of application of the legal manufacturer of medical device. For medical devices of potential risk classes 1 and 2a, the results of the factory audit shall apply to groups of medical devices. For medical devices of potential risk classes 2b and 3, the results of the factory audit shall apply to subgroups of medical devices.

When submitting an application for registration of new medical device names manufactured at a production site, the factory audit of which was previously carried out for medical devices of the same group or subgroup according to the list in accordance with Annex No. 2 to these Requirements, the applicant shall submit, as part of the documents of the registration dossier, a copy of the factory audit report conducted no earlier than 3 years before the date of submitting the application for registration of the medical device.

35. Periodic (planned) factory audit shall be carried out once every 3 years.

The legal manufacturer of medical device has the right to apply to any inspecting organization with an application for conducting a periodic (planned) factory audit within 6 months before the expiration of the validity period of the report on the results of the previous factory audit, with the submission of the following documents:

application for conducting a factory audit, indicating medical devices and their groups (subgroups) according to the list in accordance with Annex No. 2 to these Requirements and production sites included in the scope of factory audit;

information on the actual number of employees involved in the processes of the assessed quality management system for medical devices;

technical files for medical devices in accordance with Annex No. 3 to the Rules for Conducting Clinical and Clinical Laboratory Testing (Research) of Medical Devices, approved by Decision No. 29 of the Council of the Eurasian Economic Commission of February 12, 2016 (for medical devices for in vitro diagnostics - a technical file that meets the requirements according to Annex No. 5). Technical files are submitted in Russian in electronic form in a searchable format;

a copy of the report on the results of the last factory audit (if available);

a copy of the report on the results of the last audit of the quality management system for medical devices by the certification body (for certified quality management systems) (if available).

 

If the periodic (planned)  factory audit is carried out by an inspecting organization of a Member State other than the Member State whose periodic (planned)  factory audit shall be sent by the authorized body whose inspecting organization carried out the periodic (planned)  factory audit to the authorized body that carried out the registration of the medical device for inclusion in the registration dossier. Reports on the results of the periodic (planned)  factory audit shall be sent by registered mail with acknowledgment of receipt or transferred in the form of an electronic document signed with an electronic signature within 15 working days from the date of completion of the periodic (planned) factory audit.

 

36. The inspecting organization shall analyze the submitted documents within 10 working days from the date the legal manufacturer of medical device submits an application for conducting a periodic (planned)  factory audit. If the inspecting organization has decided to conduct a periodic (planned) factory audit, it shall conclude a corresponding agreement with the legal manufacturer of medical device.

If a negative decision is made, the inspecting organization shall notify the the legal manufacturer of medical device in writing of the refusal to conduct a periodic (planned) factory audit (with indication of the reasons).

The grounds for refusing to conduct a periodic (planned) factory audit are:

non-compliance of the submitted set of documents with the list of documents specified in paragraph 35 of these Requirements;

non-compliance of technical files with established requirements;

lack of authority of the inspecting organization to conduct factory audits of the declared groups (subgroups) of medical devices.

 

The schedule for conducting periodic (planned) factory audits shall be posted on the official websites of authorized bodies on the Internet, and shall also be published on the information portal of the Union.

Authorized bodies shall ensure the submission of relevant information to the Eurasian Economic Commission using the means of the integrated information system of the Union.

 

37. During the periodic (planned) factory audit, the following are assessed:

a) maintaining compliance of the quality management system for medical devices with these Requirements;

b) the effectiveness of the quality management system for medical devices in ensuring compliance of medical devices placed on the market within the Union with the applicable General Requirements for Safety and Effectiveness.

 

38. Periodic (planned)  factory audit shall be conducted at production sites selected by the inspecting organization in accordance with subparagraph "d" of paragraph 14 of these Requirements, using representative medical devices for each group or subgroup of the legal manufacturer of medical device, depending on the class of potential risk of their application, according to the list in accordance with Annex No. 2 to these Requirements, through analysis of documents and records that resulted from the implementation of the relevant documented processes and (or) operating procedures of the quality management system for medical devices, in relation to these medical devices. For medical devices of potential risk classes 1 and 2a, a representative sample of medical devices is selected from the group of medical devices according to the list in accordance with Annex No. 2 to these Requirements, and for medical devices of potential risk classes 2b and 3 - from the subgroup of medical devices according to the list in accordance with Annex No. 2 to these Requirements.

The criteria for selecting representative medical devices are the novelty of technical solutions, intended uses, and production technologies, taking into account the results of previous factory audits. The justification for the selection of representative medical devices shall be included in the factory audit report.

During periodic (planned)  and unscheduled factory audits, the inspecting organization shall select samples of medical devices (implantable, invasive, and medical devices for in vitro diagnostics) of potential risk class 3 in order to confirm that their characteristics comply with the data in the technical file, ensuring the safe use of such medical devices. Medical devices shall be selected in one model (version) from each subgroup of the legal manufacturer of medical device in accordance with Annex No. 2 to these Requirements in the quantity necessary for conducting the relevant tests. The selection criterion for representative medical devices is the commonality of technical solutions, intended uses, and (or) technologies for this subgroup of legal manufacturer of medical device. In the absence of such samples, the subgroup of medical devices shall be excluded from the scope of factory audit.

The inspecting organization shall conduct the necessary tests of the specified samples of medical devices or, if the inspecting organization does not have accreditation to conduct the corresponding type of tests, within 3 working days from the date of sample selection, issue a referral to the relevant organizations included in the unified register of authorized organizations entitled to conduct research (testing) of medical devices for the purpose of their registration.

The test results of the selected samples of medical devices shall be submitted by the inspecting organization to the authorized body within 5 working days from the date of execution of the relevant research (testing) protocol. If the characteristics of the selected medical device samples, ensuring its safe use, do not confirm compliance with the data of the technical file, the inspecting organization shall suspend the report on the results of the factory audit. Until the medical device manufacturer eliminates the identified non-conformities, the authorized body has the right to suspend the release of the medical device into circulation in the territory of the Member State in accordance with the legislation of that State, and also informs the authorized bodies of other Member States about the suspension of the release of the medical device into circulation in the territory of the Member State using the means of the integrated information system of the Union.

40. Based on the results of the periodic (planned)  factory audit, the inspecting organization shall prepare a report in the form according to Annex No. 6. This report is valid for 3 years from the date of its issue.

a) making changes to the list of production sites, the list of groups (subgroups) of medical devices to which the factory audit report applies;

b) confirmation of the elimination of violations based on the results of the factory audit;

c) confirmation of the elimination of the causes that led to the release of substandard medical devices, by including the report on the unscheduled factory audit in the final report on corrective actions in the form according to Annex No. 2 to the Rules for Monitoring the Safety, Quality and Effectiveness of Medical Devices;

d) confirmation of the implementation by the manufacturer of a quality management system for medical devices (if the assessment of this quality management system for compliance with these Requirements has not been carried out).

 

41. Based on the results of the unscheduled facroty audit for the purposes specified in subparagraphs "a" - "c" of paragraph 40 of these Requirements, the inspecting organization shall prepare a report in the form according to Annex No. 7, and for the purposes specified in subparagraph "d" of paragraph 40 of these Requirements, - in the form according to Annex No. 4 to these Requirements. The report is valid for 3 years from the date of its issue. Periodic (planned)  factory audit shall be conducted no later than 3 years from the date of issue of the report.

42. Assessment of the quality management system for medical devices is allowed using remote interaction tools (for example, by video communication). This assessment shall be carried out according to Annex No. 8 in the cases provided for in the said Annex.

(Paragraph 42 was introduced by Decision of the Council of the Eurasian Economic Commission of November 12, 2021, No. 131)

Annex No. 1

to the Requirements for the Implementation, Maintenance

and Assessment of the Quality Management

System for Medical Devices

Based on the Potential

Risk of their Application

RULES

FOR CALCULATING THE STANDARD DURATION

OF FACTORY AUDIT

 

1. The calculation of the standard duration of a factory audit shall be carried out when determining the cost of the factory audit, regardless of the actual duration of the factory audit.

2. The standard duration of a factory audit shall be calculated in person-days based on an 8-hour working day. The standard duration of a factory audit includes time spent outside the inspected organization and spent on analyzing documentation and planning the factory audit, as well as time spent directly at the inspected organization and spent on preparing reports.

  If the factory audit sites are located in a different city relative to the inspecting organization, then the standard duration of the factory audit shall be increased by 2 person-days per inspection site.

 

3. The actual number of employees of the inspected organization participating in the processes within the framework of the assessed quality management system is used as the basis for calculating the standard duration of the factory audit. The number of part-time employees shall be taken into account by converting it into an equivalent number of full-time employees.

4. The standard duration of the factory audit, depending on the actual number of employees of the inspection site, is shown in the table.

 

Table

Annex No. 2

to the Requirements for the Implementation, Maintenance

and Assessment of the Quality Management

System for Medical Devices

Based on the Potential

Risk of their Application

 

LIST OF GROUPS AND SUBGROUPS OF MEDICAL DEVICES 

 

Annex No. 3

to the Requirements for the Implementation, Maintenance

and Assessment of the Quality Management

System for Medical Devices

Based on the Potential

Risk of their Application

 

INTEGRATED ASSESSMENT

OF THE SIGNIFICANCE OF NON-CONFORMITIES OF THE QUALITY MANAGEMENT SYSTEM

IDENTIFIED DURING FACTORY AUDITS

WITH THE REQUIREMENTS FOR IMPLEMENTATION, MAINTENANCE AND ASSESSMENT OF THE SYSTEM

OF QUALITY MANAGEMENT OF MEDICAL DEVICES

BASED ON THE POTENTIAL RISK

OF THEIR APPLICATION

 

I. Classification of Non-Conformities

 

The classification of non-conformities of the quality management system identified during the factory audit with the Requirements for the Implementation, Maintenance and Assessment of the Quality Management System for Medical Devices Based on the Potential Risk of Their Application (hereinafter referred to as "non-conformities") is carried out in 2 stages:

Stage I - application of the classification matrix to ensure a preliminary assessment of the significance of non-conformities;

Stage II - application of increasing scores to determine the final assessment of the significance of non-conformities.

Multiple instances of non-compliance with a single requirement are considered as a single non-conformity.

 

II. Classification Matrix

 

According to the classification matrix, all identified non-conformities are divided into 4 groups.

Each group is characterized by a quantitative value of the significance of the non-conformity for the safety, effectiveness and quality of the medical device:

 

The classification matrix reflects the impact of the non-conformity on the safety, effectiveness, and quality of the medical device, as well as the repeatability of the identified non-conformity.

The impact of the non-conformity on the safety, effectiveness, and quality of the medical device is considered indirect if it affects the requirements related to the functioning of the quality management system for medical devices, and direct if it concerns the requirements relating to the processes of design, development, production, and final factory audit of the medical device.

The concept of "first occurrence" means that the specific non-conformity has not been identified during the 2 most recent factory audits in which the same processes within the quality management system were checked at the inspected production site.

The concept of "recurrence" means that the specific non-conformity was identified during one of the 2 most recent factory audits in which the same processes within the quality management system were checked at the inspected production site.

 

III. Increasing Scores

The quantitative value of the degree of non-conformity obtained in Stage I is refined in Stage II by applying increasing scores awarded for the presence of the following non-conformities:

absence of documented procedures relating to the processes of design, development, production, and final factory audit of the medical device, as well as to post-market surveillance, necessary to ensure the safety and effectiveness of the medical device;

release of a substandard medical device into circulation during the reporting period. If the legal manufacturer of medical device has conducted an unscheduled factory audit to confirm the elimination of the causes that led to the release of the substandard device, the increasing score is not awarded.

In this case, 1 point is added to the assessment obtained in Stage I for each non-conformity.

 

IV. Format for Presenting the Results of the Integral Assessment of the Significance of Non-Conformities

 

The results of the integral assessment of the significance of the non-conformity are presented in the form of a table:

 

The inspecting organization shall not issue a positive conclusion on the manufacturer's compliance with these Requirements if one or more violations are assessed at 5 or 6 points or more, or if more than two violations are assessed at 4 points.

Annex No. 4

to the Requirements for the Implementation, Maintenance

and Assessment of the Quality Management

System for Medical Devices

Based on the Potential

Risk of their Application

 

(Form)

 

REPORT

on the results of the initial factory audit

Annex No. 5

to the Requirements for the Implementation, Maintenance

and Assessment of the Quality Management

System for Medical Devices

Based on the Potential

Risk of their Application

 

REQUIREMENTS

FOR THE CONTENT OF THE TECHNICAL FILE FOR A MEDICAL DEVICE

FOR IN VITRO DIAGNOSTICS

 

I. General Requirements for the Content of the Technical File

for a Medical Device for In Vitro Diagnostics

 

1. The technical file shall contain the following information about the medical device for in vitro diagnostics:

  a) Name of the product;

  b) Type of product in accordance with the nomenclature of medical devices used within the Eurasian Economic Union;

  c) Class of potential risk of application and applicable classification rules in accordance with the Rules for Classification of Medical Devices Based on the Potential Risk of Application, approved by Decision No. 173 of the Board of the Eurasian Economic Commission of December 22, 2015;

  d) Intended purpose of the product, including (if applicable):

 

 Description of the target analyte, including indication of the qualitative, semi-quantitative or quantitative type of determination;

  Functional purpose;

  Specific pathology, condition or risk factor for the detection, determination or differentiation of which the product is intended;

Type of sample to be analyzed;

  Potential users;

  e) Description of the principle of the analytical method or the principle of operation of the device;

  f) Description of the constituent parts, including a list of possible design options for the product under consideration;

  g) Description of accessories, other products (including medical devices) intended to be used in combination with the product;

  h) Description of materials for taking and transporting samples or a description (characteristics) of materials recommended for this purpose;

  i) For analytical equipment - technical specifications.

 

2. If information about similar or previous modifications of the medical device for in vitro diagnostics is used to prove its compliance with the General Safety and Performance Requirements for Medical Devices, the requirements for their labeling and operational documentation, approved by Decision No. 27 of the Council of the Eurasian Economic Commission of February 12, 2016 (hereinafter referred to as the "General Safety and Performance Requirements"), the technical file shall contain a brief description of:

  a) Previous modifications of the product under consideration (if any);

  b) Similar modifications of medical devices in circulation within the Eurasian Economic Union and in international markets.

 

II. Accompanying Information

 

3. The technical file shall contain:

  a) Data on the labeling of the medical device for in vitro diagnostics and its packaging;

  b) Instructions for use (operational documentation) of the medical device for in vitro diagnostics (if any).

 

III. Information on Compliance with the General Safety and Performance Requirements

 

4. The technical file shall include a checklist of compliance with the General Safety and Performance Requirements in accordance with Annex No. 2 to the General Safety and Performance Requirements.

 

IV. Results of Risk Analysis and Management

 

5. The technical file shall contain a brief list of risks identified in the risk analysis process and a description of how these risks are managed to reduce them to acceptable levels.

 

V. Design and Development of the Medical Device for In Vitro Diagnostics

 

6. The technical file shall contain information on the main stages of design of the medical device for in vitro diagnostics under consideration. This information may be presented in the form of a process flow chart.

 

VI. Production Processes

 

7. The technical file shall contain information on production processes, including the production, assembly, final testing of the medical device for in vitro diagnostics, and final packaging of the finished medical device for in vitro diagnostics. This information may be presented in the form of a process flow chart.

 

VII. Production Sites

 

8. The technical file shall contain information on the production sites where the medical device for in vitro diagnostics under consideration is manufactured. If there are quality management system certificates or equivalent documents for these sites, copies of them shall be attached to the technical file.

 

VIII. Verification and Validation Activities

 

9. The technical file shall contain the following information and documents on verification and validation that were used to prove the compliance of the medical device for in vitro diagnostics with the General Safety and Performance Requirements:

  a) A list of the standards applied by the legal manufacturer of medical device;

  b) Test results from testing laboratories (centers);

  c) Results of laboratory and (or) factory tests;

  d) Declarations of conformity to the standards from the list of standards, as a result of the application of which, on a voluntary basis, compliance with the General Safety and Performance Requirements is fully or partially ensured;

  e) Declarations of conformity to standards that are not included in the list referred to in subparagraph "d" of this paragraph (with justification for their application);

  f) A review of published literature sources regarding the medical device for in vitro diagnostics under consideration or similar medical devices;

  g) Clinical evidence of the effectiveness and safety of the medical device for in vitro diagnostics.

 

10. The technical file shall contain the following information on the analytical performance of the medical device for in vitro diagnostics (if applicable):

  a) Analytical sensitivity (detection limit);

  b) Analytical specificity;

  c) Accuracy of determinations;

  d) Random error;

  e) Data on the metrological traceability of the values of calibrators and control materials;

  f) Data on the analytical range (linearity range - for linear analytical systems), as well as a description of methods for determining characteristics;

  g) Data on the determination of the "cut-off point," including a description of the details of the method for determining characteristics;

  h) Population (demographic) aspects of the use of the medical device for in vitro diagnostics.

 

11. The technical file shall contain information on the scientific validity of the analyte (if applicable).

12. The technical file shall contain information on the clinical performance of the medical device for in vitro diagnostics, including (if applicable) data on diagnostic sensitivity and diagnostic specificity.

13. The technical file shall contain data on the stability of the medical device for in vitro diagnostics.

 

14. If the medical device for in vitro diagnostics is manufactured in sterile form, a description of the sterilization method is given, including a validation report regarding the sterilization process.

15. The technical file shall include a brief summary of the results of the verification and validation activities of the software performed in the manufacturing organization.

 

Annex No. 6

to the Requirements for the Implementation, Maintenance

and Assessment of the Quality Management

System for Medical Devices

Based on the Potential

Risk of their Application

 

(Form)

 

REPORT

on the results of the periodic (planned)

factory audit

 

Annex No. 7

to the Requirements for the Implementation, Maintenance

and Assessment of the Quality Management

System for Medical Devices

Based on the Potential

Risk of their Application

 

(Form)

 

REPORT

on the results of the unscheduled factory audit

 

Annex No. 8

to the Requirements for the Implementation, Maintenance

and Assessment of the Quality Management System for Medical Devices

Based on the Potential Risk of their Application

 

ASSESSMENT

OF THE QUALITY MANAGEMENT SYSTEM FOR MEDICAL DEVICES

CONDUCTED USING REMOTE

INTERACTION TOOLS

 

(introduced by the Decision of the Council of the Eurasian Economic Commission

dated November 12, 2021 No. 131)

 

1. It is permissible, by decision of the authorized body, to conduct an assessment of the quality management system for a medical device using remote interaction tools (for example, via video communication) in accordance with the acts included in the law of the Eurasian Economic Union, in the following cases:

  a) The threat of occurrence, occurrence, and elimination of an emergency situation and (or) the emergence of a threat of the spread of epidemic diseases that pose a danger to others, diseases and lesions resulting from exposure to adverse chemical, biological, and radiation factors;

  b) The occurrence of emergencies or situations beyond the control of the parties that pose a threat of harm to the life and health of inspectors.

 

2. Before the start of the assessment of the quality management system for a medical device, conducted using remote interaction tools, the manufacturer must confirm the geolocation data (latitude, longitude) of the location of the production site.

3. To conduct the assessment of the quality management system for a medical device, conducted using remote interaction tools, the manufacturer provides the documents and information specified in the table.

 

Table