Decision of the Council of the Eurasian Economic Commission No. 106 dated November 10, 2017

(as amended on August 19, 2022)

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

COUNCIL OF THE EURASIAN ECONOMIC COMMISSION

DECISION

dated November 10, 2017. N 106

ABOUT THE REQUIREMENTS

TO IMPLEMENT, MAINTAIN AND EVALUATE

QUALITY MANAGEMENT SYSTEMS FOR MEDICAL DEVICES

DEPENDING ON THE POTENTIAL RISK OF THEIR USE

List of amending documents

(ed. decisions of the Council of the Eurasian Economic Commission

from 12.11.2021 N 131, from 19.08.2022 N 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 of circulation of medical devices (medical devices and medical equipment) within the Eurasian Economic Union of December 23, 2014, paragraph 107 of Annex N 1 to the Regulations of the Eurasian Economic Commission, approved by Decision of the Supreme Eurasian Economic Council of December 23, 2014 N 98, and in order to implement the Decision of the Supreme Eurasian Economic Council of December 23 de
1. To approve the attached Requirements for implementation, maintenance and evaluation of the quality management system for medical devices depending on the potential risk of their use (hereinafter referred to as the Requirements).
2. Establish that:
(a) Within 12 months from the date of entry into force of this Decision:
assessment of the medical device manufacturer's quality management system 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, as part of the registration dossier, documents confirming that the manufacturer of the medical device has production conditions for the medical device applied for registration that comply with the requirements of the legislation of the Eurasian Economic Union member state to whose authorized body the application is submitted (if any such requirements exist), and Quality Management Systems. System requirements for regulatory purposes" or the relevant national (state) or international standard, as well as copies of reports on earlier inspections for compliance with ISO 13485 (if available);
b) manufacturers 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 the Decision of the Council of the Eurasian Economic Commission of February 12, 2016. N 46, must confirm the implementation of the quality management system by passing an unscheduled inspection of production in accordance with the Requirements within 2 years from the date of registration of the medical device;
c) paragraphs three and four of paragraph 3 of the Requirements shall come into force from 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 the Decision of the Council of the Eurasian Economic Commission of February 12, 2016. N 46.
3. The granting of powers to inspection organizations to conduct inspections of manufacturers of medical devices is carried out by a government authority of a member state of the Eurasian Economic Union authorized to carry out and (or) coordinate activities in the sphere 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 come into force upon expiration of 10 calendar days from the date of its official publication.

Members of the Council of the Eurasian Economic Commission:

Approved

By decision of the Council

Eurasian Economic Commission

dated November 10, 2017. N 106

REQUIREMENTS

TO IMPLEMENT, MAINTAIN AND EVALUATE

QUALITY MANAGEMENT SYSTEMS FOR MEDICAL DEVICES

DEPENDING ON THE POTENTIAL RISK OF THEIR USE

List of amending documents

(ed. decisions of the Council of the Eurasian Economic Commission

from 12.11.2021 N 131, from 19.08.2022 N 133)

I. 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 Uniform Principles and Rules for the Circulation of Medical Devices (Medical Devices and Medical Equipment) within the Eurasian Economic Union of December 23, 2014 and establish within the Eurasian Economic Union (hereinafter - the Union) the requirements for the implementation, maintenance and evaluation of the quality management system of medical devices depending on the potential risk of their use.
2. For the purposes of these Requirements, the terms used shall mean the following:
"manufacturing inspection" means an assessment of the manufacturing conditions and quality management system of a medical device manufacturer for compliance with these Requirements;
"inspecting organization" - an authorized body or an organization under the authority (subordination) of the authorized body and empowered to inspect the production of medical devices;
(in edition of the decision of the Council of the Eurasian Economic Commission from 19.08.2022 N 133)
"corrective action" - An action taken by a manufacturer of medical devices to eliminate the cause of a detected nonconformity or adverse event;
"correction" - an action taken to correct a nonconformity that has been detected;
"critical supplier" means a supplier whose products or services have a direct impact on the safety and/or effectiveness of a medical device;
"substandard medical device" - a medical device that does not meet the general requirements for safety and effectiveness of medical devices, requirements for their labeling, technical and operational documentation for them and cannot be safely used for the intended purpose established by the manufacturer;
"evaluation of the medical device quality management system" - confirmation of the implementation, maintenance and performance of the medical device quality management system to ensure compliance of medical devices released into circulation within the Union with the General requirements for the safety and effectiveness of medical devices applicable to them, the requirements for their labeling, technical and operational documentation for them, approved by the Decision of the Council of the Eurasian Economic Commission of February 12, 2016. N 27;
"post-sale monitoring" - a system for collecting and analyzing data from the manufacturer of medical devices on the use of medical devices, tracking and detecting adverse effects of medical devices in the process of their use;
"preventive action" - An action taken to eliminate the cause of a potential nonconformity or potentially undesirable situation;
"production site" means a territorially separate complex designed to perform the entire process of production of a medical device or certain stages thereof;
"medical device quality management system" means the organizational structure, functions, procedures, processes and resources required for coordinated activities for the leadership and management of a medical device manufacturing organization with respect to quality;
"authorized body" - a body of state power of a Member State of the Union authorized to carry out and (or) coordinate activities in the sphere of circulation of medical devices on the territory of this State;
"production conditions" - infrastructure and production environment necessary to ensure compliance of manufactured medical devices with the General requirements of effectiveness and safety, requirements for their labeling, technical and operational documentation for them, approved by the Decision of the Council of the Eurasian Economic Commission of February 12, 2016. N 27.

II. Requirements to the quality management system of medical

products depending on the potential risk of their use

3. Manufacturers of medical devices (except for manufacturers of medical devices of potential application risk class 1 and non-sterile medical devices of potential application risk class 2a) are obliged to implement a quality management system for medical devices depending on the potential application risk class before submitting documents for registration of medical devices.
Manufacturers of medical devices of potential application risk class 1 and non-sterile medical devices of potential application risk class 2a have the right to implement and maintain a quality management system for medical devices.
If manufacturers of medical devices of potential application risk class 1 and non-sterile medical devices of potential application risk class 2a have undergone assessment of the medical device quality management system, including design and development processes, in accordance with these Requirements, then during the period of validity of the conclusion contained in the report on the results of production inspection, amendments to the registration dossier of such medical devices shall be made without expert review.
The manufacturer of the medical device within 2 months from the date of making changes to the documents of the registration dossier submitted for registration of the medical device, shall notify the relevant changes in the form in accordance with Annex N 7 to the Rules for Registration and Examination of Safety, Quality and Effectiveness of Medical Devices, approved by the Decision of the Council of the Eurasian Economic Commission of February 12, 2016. N 46, the authorized body that issued the registration certificate of the medical device.
4. Manufacturers of medical devices of classes of potential risk of use 2a (for medical devices produced in sterile form) and 2b are obliged to implement a quality management system for medical devices (except for the implementation of design and development processes) before submitting documents for registration of medical devices.
5. Manufacturers of medical devices of potential application risk class 3 are obliged to implement a quality management system for medical devices, including design and development processes, before submitting documents for registration of medical devices.
6. The quality management system of medical devices shall ensure compliance of medical devices put into circulation within the Union with the General Requirements of Safety and Effectiveness of Medical Devices applicable to them, requirements for their labeling, technical and operational documentation for them, approved by the Decision of the Council of the Eurasian Economic Commission dated February 12, 2016. N 27 (hereinafter - General Requirements of Safety and Effectiveness).
7. In order to implement a quality management system for medical devices, the manufacturer of medical devices shall:
(a) Develop documented requirements for risk management at all stages of the life cycle of medical devices;
b) determine the processes necessary for the effective functioning of the quality management system of medical devices (hereinafter - processes), and the application of processes in the organization - manufacturer of medical devices;
c) determine the sequence and interrelationship of processes;
d) define the criteria and methods necessary to ensure performance, both in the implementation of processes and in the management of processes;
(e) Ensure that the production conditions, resources and information necessary to support the processes and to monitor the processes are available;
(e) Monitor, measure (where applicable) and analyze processes;
g) take the measures necessary to achieve the planned results and maintain the effectiveness of the processes.
8. All elements of the quality management system for medical devices (organizational structure, methodologies and process descriptions) shall be documented and kept up to date.
The documentation of the quality management system of medical devices shall be drawn up on paper, and if the legislation of a Member State of the Union (hereinafter - Member State) provides for the possibility of drawing up the said documentation in electronic form, - on an electronic medium. 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 medical device quality management system shall, among other things, contain a description:
a) the requirements for the technical characteristics of the medical device, the standards or individual sections (paragraphs, subparagraphs) of the standards to be applied and, where the relevant standards will not be applied, the methods to be used to ensure that the General Safety and Effectiveness Requirements applicable to manufactured medical devices are met;
b) methods and depth of third party control in case the development, production and (or) output control are performed by a third party;
c) the manufacturing, quality control and quality assurance processes of the medical device, the processes and systematic measures that will be used for quality control and quality assurance of the medical device, including corrective and preventive action processes;
d) documents recording quality indicators of the medical device (reports on internal checks, inspections, 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;
(e) Consumer feedback plans, procedures and documents (including monitoring the safety and efficacy of the medical device at the post-sale stage).
10. Manufacturers of medical devices that have implemented a quality management system for medical devices in accordance with these Requirements shall keep it up to date and ensure its effectiveness.

III. Requirements for evaluation of the quality management system

medical devices

11. evaluation of the quality management system of medical devices is carried out by inspection organizations in the form of production inspection.
12. Costs associated with the inspection of production within the framework of evaluation of the quality management system of medical devices shall be borne by the manufacturer of the medical device on the basis of a contract concluded with the inspecting organization. Tariffs for carrying out production inspection shall be established in accordance with the legislation of the Member States.
Calculation of the normative duration of production inspection is carried out according to rules according to Appendix N 1.
13. The inspecting organization shall not be interested in the results of the production inspection.
The inspecting organization, its management and employees involved in the production inspection shall not be involved in activities that may affect the independence of their judgment or their impartiality with respect to the results of the production inspection, nor shall they be developers, manufacturers, suppliers of medical devices, nor shall they perform maintenance (repair) of the medical devices they are evaluating, nor shall they be authorized representatives of
14. The inspecting organization shall document processes covering:
(a) Processing a request for a manufacturing inspection from a medical device manufacturer;
b) planning, conducting and reporting on the production inspection;
c) the terms and conditions of the manufacturing inspection contract concluded with the manufacturer of the medical device or its authorized representative;
d) identification of production sites to be subjected to production inspections;
e) drawing up reports with a conclusion on compliance or non-compliance of the medical device quality management system with these Requirements;
(e) Monitoring of corrective actions to eliminate non-conformities identified during the production inspection;
g) allocation of responsibilities and authorities of inspection team members when inspecting production (taking into account their competence) and, if necessary, involvement of external experts.
15. The inspection organization shall develop and implement procedures for initially determining the competence of inspectors at the time of their appointment and for continuously maintaining it.
Inspectors must have a higher education diploma with specialization in medicine, natural sciences or engineering, at least 3 years of work experience in the field of evaluation of safety, quality and effectiveness of medical devices and (or) state control over the circulation of medical devices, and must also possess:
Knowledge of the manufacturing processes and technologies used by medical device manufacturers;
knowledge of the requirements of effectiveness and safety of medical devices, technologies and risks of their medical use;
knowledge of the standards of the medical device quality management system and the medical device risk management system;
knowledge of the basics of probability theory and statistics (including techniques for determining confidence levels for representative samples and regression analysis).
The competence of inspectors referred to in paragraphs three and four of this paragraph shall be confirmed for subgroups of medical devices according to the list in Annex N 2. The inspecting organization shall document the areas of competence of its inspectors. The records of the competencies of inspectors shall be kept up to date and shall be taken into account when appointing inspectors to inspect the production of the medical devices concerned.
The inspecting organization shall verify the professional level of inspectors in order to confirm their competence through certification and subsequent recertification at least once every 3 years.
16. The inspecting organization shall implement a documented procedure for ensuring confidentiality of information constituting a commercial secret and obtained in the course of inspections, taking into account the possibility of engaging external experts and participation of inspectors (experts) from authorized bodies.
The confidentiality agreement concluded between the inspection organization and the manufacturer of medical devices shall contain provisions providing for the possibility of submitting materials on the results of the inspection to the authorized body, as well as to any other authorized bodies between which confidentiality agreements exist.
17. The inspecting organization shall maintain and retain for at least 10 years records of inspections and other activities for all medical device manufacturers that have applied for and/or passed a manufacturing inspection, which shall include:
(a) Information on the application and reports on the results of the production inspection;
b) a contract for inspection of production;
c) justification of the duration of the production inspection;
d) control over the implementation of corrective actions based on the results of inspections;
e) records of complaints and appeals and subsequent corrective actions;
(e) Documents attesting to the competence of inspectors and external experts.
18. Authorization of inspecting organizations to conduct inspections of manufacturers of medical devices, except for cases when 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 N 2 to these Requirements on the basis of assessment of their compliance with these Requirements.
The Authorized Body shall have the right to determine the number of inspecting organizations to conduct production inspection at the request of medical device manufacturers and (or) in accordance with production inspection schedules within a period not exceeding 3 months from the date of submission by a medical device manufacturer of a complete set of documentation, including documents on payment for production inspection.
The list of inspection organizations shall be placed on the websites of the authorized bodies in the information and telecommunication network "Internet" (hereinafter - the Internet), as well as published on the information portal of the Union.
Authorized bodies within 3 working days from the date of making changes to the information contained in the list of inspection organizations, 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 in 2 years conduct inspections of inspecting organizations, except for cases when the inspecting organizations are Authorized Bodies, for compliance with these Requirements. The Authorized Bodies shall, not later than 3 months prior to the start of the inspection, place on their official Internet sites the schedules of inspections of inspecting organizations, which shall be available to the inspecting organizations and Authorized Bodies.
Where the inspection organization is a competent authority, control over its activities shall be exercised in accordance with the procedure established by the legislation of the Member State.
The authority of the inspecting organization may be revoked by the authorized body if, based on the results of the inspection, it is determined that the inspecting organization does not comply with these Requirements.
Authorized bodies shall have the right to send at their own expense their representatives to participate in the inspection of the inspecting organization as inspectors (experts), except for cases when the inspecting organizations are authorized bodies. Based on the results of the inspection, the inspector (expert) shall have the right to submit written comments and suggestions to the authorized body conducting the inspection.
20. Authorized bodies within the framework of coordination of work in the field of administration of inspections, development of mechanisms of mutual expert evaluation have the right to send at their own expense their inspectors (experts) to participate in the inspection of production within the framework of evaluation of the quality management system of the medical device. The manufacturer of the medical device shall be obliged to provide access of the members of the team of inspectors (experts) to the objects of inspection.
21. Reports on the results of production inspection shall be sent by the inspecting organization to the authorized body for inclusion in the registration dossier by registered mail with acknowledgement 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 production inspection.
22. The inspection organization conducting the production inspection shall not issue a positive opinion if the quality management system for medical devices does not comply with these Requirements or is not kept up to date.
Integral assessment of the significance of nonconformities of the quality management system of medical devices to these Requirements revealed in the course of production inspection is carried out according to Appendix N 3.
Non-conformities identified as a result of the manufacturing inspection shall be corrected by the medical device manufacturer during the manufacturing inspection or within a period not exceeding 30 working days from the date of completion of the manufacturing inspection.
23. If the manufacturer of a medical device does not agree with the negative conclusion or identified nonconformities, it shall send a claim to the inspecting organization within 30 working days from the date of receipt by the inspecting organization of a copy of the report on the results of the production inspection. The inspecting organization shall be obliged to consider the said claim and send a reply within 15 working days from the day of its receipt. In case of failure to reach an agreement, the manufacturer of the medical device shall have the right to file a complaint with the court at the location of the inspecting organization or with the authorized body that has authorized the organization to assess the quality management systems of medical devices. In case the manufacturer of the medical device does not agree with the decision of the authorized body, he/she shall have the right to appeal this decision in court at the location of the authorized body.
If the manufacturer of the medical device fails to eliminate or violates the terms of elimination of remarks, the inspecting organization shall inform the authorized body that authorized the organization to assess the quality management systems of medical devices.
Until the manufacturer of the medical device eliminates the remarks contained in the report on the results of the production inspection, the authorized body shall have the right to suspend the release of the medical device into circulation in the territory of a 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 of 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 a manufacturing inspection, the quality management system for medical devices is evaluated for the following processes:
design and development processes, if they are included in the quality management system of the medical device manufacturer;
Document and records management processes;
production and output control processes;
corrective and preventive action processes;
consumer-related processes.
If the manufacturer of a 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, the evidence of compliance of the quality management system with the requirements of these standards (certificate of conformity, audit reports on 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, inspection is limited to verification of fulfillment of requirements related to the processes of design, development, production and output control of the medical device and to the processes related to the consumer (in terms of post-sale monitoring).
25. Evaluation of the processes for designing and developing a quality management system for medical devices includes:
(a) Confirmation that design and development procedures (including risk management) are in place;
b) analysis of documents describing the design procedure and covering the model range of a medical device;
c) confirmation, based on selected medical device design records, that design and development procedures have been established and applied;
d) confirmation that the inputs to the design process have been developed taking into account the intended use of the medical device and the relevant provisions of the General Safety and Effectiveness Requirements;
e) review of medical product specifications to confirm that the outputs of the medical product design that ensure the safety and effectiveness of the medical product when used as intended have been determined;
(e) confirmation that risk management activities have been identified and implemented, risk tolerance criteria have been established and are appropriate, any residual risk has been assessed and, where necessary, communicated to the customer in accordance with the General Safety and Performance Requirements.
26. Evaluation of the medical device quality management system's documentation and records management processes includes:
(a) Confirmation that procedures for the identification, retention and disposal (destruction) of documents and records (including change management) have been established;
b) confirmation that the documents necessary for the organization to be able to plan, execute and manage production processes are in place;
c) confirmation that the documentation for the medical device includes:
evidence of compliance of medical devices with requirements (including requirements of applicable standards);
A description of medical devices, including instructions for use, materials and specifications;
consolidated documentation on verification and validation of projects (including data from clinical trials (tests) in accordance with the Rules of clinical and clinical-laboratory tests (trials) of medical devices, approved by the Decision of the Council of the Eurasian Economic Commission of February 12, 2016. N 29);
labeling of medical devices;
risk management documents.
27. Evaluation of manufacturing processes and output control of medical devices includes:
(a) Analysis of production processes for manufacturing serialized products (including production conditions);
b) evaluation of sterilization processes (for medical devices produced in sterile form), including:
determination that sterilization processes have been documented, records of sterilization process parameters for each batch of medical devices being sterilized are maintained;
Determining that the sterilization process has been validated;
Determining that the sterilization process is being carried out according to the established parameters;
c) confirmation that the production processes are manageable and controllable and operate within the established limits, as well as confirmation that the required level of control of products and/or services of critical suppliers is ensured;
d) confirmation of identification and traceability of medical devices and processes of their production, as well as their compliance with the established requirements;
e) confirmation that the output control activities of medical devices ensure compliance of medical devices with the established requirements and have been documented.
28. Evaluation of corrective and preventive action processes of the medical device quality management system includes:
(a) Confirmation that corrective and preventive action procedures have been developed;
b) confirmation that the controls prevent the distribution of medical devices whose quality does not meet the General Requirements for Safety and Effectiveness of Medical Devices;
c) confirmation that corrective and preventive actions are effective;
d) confirmation that the manufacturer of the medical device has developed an effective procedure for issuing and applying notifications on the safety of medical devices in accordance with the Rules for Monitoring the Safety, Quality and Effectiveness of Medical Devices, approved by Decision of the Board of the Eurasian Economic Commission of December 22, 2015 N 174 (hereinafter - Rules for Monitoring the Safety, Quality and Effectiveness of Medical Devices).
29. Evaluation of consumer-related processes of the medical device quality management system includes:
a) confirmation that the manufacturer of the medical device has taken measures necessary to establish communication with consumers in order to perform the necessary corrective and preventive actions, has a system for collecting and analyzing data on the safety and effectiveness of medical devices at the post-sale stage and keeps it up to date, as well as sends to the authorized body reports on the results of post-sale monitoring of the safety and effectiveness of medical devices in accordance with the Rules for monitoring
b) confirmation that consumer feedback is analyzed by the medical device manufacturer during product life cycle processes and is used to re-assess risk and, if necessary, to update risk management activities.
30. Evaluation of the quality management system of medical devices is carried out in the form of primary, periodic (scheduled) and unscheduled inspection of production.
31. The initial inspection of production shall be carried out during the procedure for the registration of a medical device within the Union.
32. During the initial production inspection, the inspecting organization shall inspect the production of all production sites declared by the manufacturer of medical devices.
If one production site produces medical devices belonging to several groups (subgroups) of medical devices according to the list in accordance with Annex N 2 to these Requirements depending on the class of potential risk of their use, inspection of production within one inspection may cover several groups (subgroups) of medical devices in accordance with the production sites declared by the manufacturer of medical devices.
33. According to the results of the conducted primary inspection of production, the inspecting organization draws up a report in the form according to Appendix No. 4. The said report shall be valid for 3 years from the date of its issuance.
34. The results of the production inspection shall apply to a group (subgroup) of medical devices according to the list in accordance with Annex N 2 to these Requirements, depending on the class of potential risk of use of the manufactured medical devices. For medical devices of classes of potential risk of use 1 and 2a, the results of production inspection shall apply to groups of medical devices. For medical devices of classes of potential risk of use 26 and 3, the results of production inspection shall apply to subgroups of medical devices.
When submitting an application for registration of new names of medical devices manufactured at a production site, the inspection of which was conducted earlier 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 report on the results of the inspection of production conducted not earlier than 3 years prior to the date of submission of the application for registration of the medical device.
35. Periodic (scheduled) inspection of production is carried out once every 3 years.
The manufacturer of a medical device has the right to apply to any inspection organization with an application for periodic (scheduled) production inspection within 6 months prior to the expiration of the validity of the report on the results of the previous production inspection with the submission of the following documents:
application for inspection of production with indication of medical devices and their groups (subgroups) according to the list in accordance with Appendix N 2 to these Requirements and production sites included in the inspection area;
certificate on the actual number of employees involved in the processes of the assessed quality management system of medical devices;
technical files for medical devices in accordance with Annex N 3 to the Rules for clinical and clinical-laboratory tests (research) of medical devices, approved by the Decision of the Council of the Eurasian Economic Commission of February 12, 2016. N 29 (for medical devices for in vitro diagnostics - technical file, complying with the requirements according to Appendix N 5). Technical files shall be submitted in Russian in searchable electronic format;
copy of the report on the results of the last production inspection (if any);
copy of the report on the results of the certification body's (for certified quality management systems) last audit of the quality management system of medical devices (if any).
If periodic (scheduled) production inspection is carried out by an inspection organization of a Member State other than the one whose authorized body carried out registration of the medical device, reports on the results of periodic (scheduled) production inspection shall be sent by the authorized body whose inspection organization carried out periodic (scheduled) production inspection to the authorized body which carried out registration of the medical device for inclusion in the registration list of the medical device Reports on the results of periodic (scheduled) inspection of production shall be sent by registered mail with acknowledgement of receipt or transmitted in the form of an electronic document signed with an electronic signature within 15 working days from the date of completion of periodic (scheduled) inspection of production.
36. The inspecting organization shall analyze the submitted documents within 10 working days from the date of submission by the medical device manufacturer of an application for periodic (scheduled) production inspection. If the inspecting organization has decided to conduct periodic (scheduled) production inspection, it shall conclude a relevant contract with the medical device manufacturer.
If a negative decision is made, the inspecting organization shall notify in writing the medical device manufacturer of the refusal to conduct periodic (scheduled) inspection of production (specifying the reasons).
The grounds for refusal to conduct periodic (scheduled) inspection of production 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 the established requirements;
lack of authority of the inspecting organization to inspect the declared groups (subgroups) of medical devices.
The schedule of periodic (scheduled) inspection of production shall be placed on the official websites of the authorized bodies in the Internet, as well as published on the information portal of the Union.
Authorized bodies ensure that the relevant information is submitted to Eurasian Economic Commission using the means of the Union's integrated information system.
37. When conducting periodic (scheduled) production inspections, the following shall be assessed:
a) maintaining compliance of the medical device quality management system with these Requirements;
b) the effectiveness of the quality management system for medical devices in ensuring compliance of medical devices released into circulation within the Union with the General Safety and Effectiveness Requirements applicable to them.
38. Periodic (scheduled) inspection of production is carried out at the production sites selected by the inspecting organization in accordance with subparagraph "d" of paragraph 14 of these Requirements on a sample of representative medical devices for each group or subgroup of manufactured medical devices depending on the class of potential risk of their application according to the list in accordance with Annex N 2 to these Requirements through analysis of documents and records that resulted from the implementation of the relevant documented For medical devices of potential risk classes 1 and 2a, a representative sample of medical devices shall be selected from the group of medical devices according to the list in accordance with Annex N 2 to these Requirements, for medical devices of potential risk classes 2b and 3 - from the subgroup of medical devices according to the list in accordance with Annex N 2 to these Requirements.
The criteria for selection of representative medical devices are novelty of technical solutions, prescriptions, production technologies, taking into account the results of previous inspections. Justification of the selection of representative medical devices shall be given in the report on the results of production inspection.
During periodic (scheduled) and unscheduled inspection of production, the inspecting organization conducts sampling of medical devices (implantable, invasive, as well as medical devices for in vitro diagnostics) of potential risk class 3 in order to confirm compliance of their characteristics with the technical file data ensuring safe use of such medical devices. Medical devices shall be selected one model (design variant) from each subgroup of manufactured medical devices in accordance with Annex No. 2 to these Requirements in the quantity necessary to conduct appropriate tests. The criterion for selection of representative medical devices is commonality of technical solutions, purposes and (or) technologies for this subgroup of manufactured medical devices. In the absence of the specified samples, the subgroup of medical devices shall be excluded from the scope of inspection.
The inspecting organization conducts the necessary tests of the specified samples of medical devices or, in case the inspecting organization has no accreditation to conduct the appropriate type of tests, within 3 working days from the date of sampling, issues a referral to the appropriate organizations included in the unified register of authorized organizations having the right to conduct research (tests) of medical devices for the purpose of their registration.
The results of tests of 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 (test) protocol. In case of non-confirmation of conformity of characteristics of selected samples of a medical device with the data of the technical file ensuring its safe use, the inspecting organization shall suspend the report on the results of production inspection. Until the manufacturer of the medical device eliminates the identified nonconformities, the authorized body shall have the right to suspend the release of the medical device into circulation in the territory of a Member State in accordance with the legislation of that State, and shall also inform the authorized bodies of other Member States of 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.
39. Based on the results of periodic (scheduled) inspection of production, the inspecting organization draws up a report in the form according to Appendix N 6. The said report shall be valid for 3 years from the date of its issuance.
40. A manufacturer of medical devices has the right to apply to the inspecting organization for an unscheduled production inspection for the following purposes:
a) amendments to the list of production sites, the list of groups (subgroups) of medical devices covered by the inspection report;
b) confirmation of elimination of violations based on the results of production inspection;
c) confirmation of elimination of the causes that led to the release of substandard medical devices by including the report on unscheduled inspection in the final report on corrective actions in the form in accordance with Annex N 2 to the Rules for Monitoring of Safety, Quality and Effectiveness of Medical Devices;
d) confirmation of the manufacturer's implementation of the quality management system for medical devices (if the evaluation of this quality management system for compliance with these Requirements has not been carried out).
41. Based on the results of unscheduled inspection of production for the purposes specified in subparagraphs "a" - "c" of paragraph 40 of these Requirements, the inspecting organization shall issue a report in the form according to Annex N 7, for the purposes specified in subparagraph "d" of paragraph 40 of these Requirements - in the form according to Annex N 4 to these Requirements. The said report shall be valid for 3 years from the date of its issuance. Scheduled inspection shall be carried out not later than 3 years from the date of issuance of the said report.
42. It is allowed to conduct an assessment of the quality management system of medical devices with using means of remote interaction (for example, by video link). Such assessment shall be conducted in accordance with Annex N 8 in cases provided for by this Annex.
(paragraph 42 introduced by the decision of the Council of the Eurasian Economic Commission from 12.11.2021 N 131)

Annex N 1

to the Requirements for implementation, maintenance

and evaluation of the management system

medical device quality

depending on the potential

application risks

RULES.

CALCULATING THE STANDARD DURATION

PRODUCTION INSPECTIONS

1. The calculation of the standard duration of production inspection shall be carried out when determining the cost of production inspection irrespective of the actual duration of production inspection.
2. The standard duration of production inspection is calculated in man-days based on an 8-hour working day. The standard duration of production inspection includes time spent outside the inspected organization spent on the analysis of documentation and planning of production inspection, as well as time spent directly in the inspected organization spent on report writing.
If production inspection facilities are located in another city in relation to the inspecting organization, the standard duration of production inspection shall be increased by 2 man-days for each inspection facility.
3. The actual number of employees of the inspected organization involved in the processes of the quality management system being assessed is used as the basis for calculating the standard duration of the production inspection. The number of part-time employees is taken into account by converting it to the equivalent number of full-time employees.
4. The standard duration of production inspection depending on the actual number of employees of the inspected facility is given in the table below.

Table

Annex N 3

to the Requirements for implementation, maintenance

and evaluation of the management system

medical device quality

depending on the potential

application risks

INTEGRAL ASSESSMENT

THE DEGREE OF SIGNIFICANCE OF THE FINDINGS IDENTIFIED DURING THE INSPECTION

PRODUCTION OF NON-CONFORMITIES OF THE QUALITY MANAGEMENT SYSTEM

REQUIREMENTS FOR IMPLEMENTING, MAINTAINING AND EVALUATING THE SYSTEM

QUALITY MANAGEMENT OF MEDICAL DEVICES

DEPENDING ON THE POTENTIAL RISK

THEIR APPLICATIONS

I. Classification of non-conformities

Classification of non-conformities of the quality management system identified during the production inspection to the Requirements for implementation, maintenance and evaluation of the quality management system of medical devices depending on the potential risk of their use (hereinafter - non-conformities) is carried out in 2 stages:
Stage I - application of the classification matrix to provide a preliminary assessment of the degree of significance of nonconformities;
Stage II - application of increasing points to determine the final assessment of the degree of significance of nonconformities.
Multiple instances of non-compliance with a single requirement shall be treated as a single non-compliance.

II. Classification matrix

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

Each group is characterized by a quantitative value of the degree of significance of the nonconformity for the safety, efficacy and quality of the medical device:

The classification matrix reflects the impact of the nonconformity on the safety, efficacy and quality of the medical device, as well as the repeatability of the identified nonconformity.
The effect of a non-conformity on the safety, efficacy and quality of a medical device is considered indirect if it affects requirements related to the operation of the medical device quality management system, and direct if it affects requirements related to the design, development, manufacturing and output control processes of the medical device.
The term "for the first time" means that the specific non-conformity was not detected in the last 2 production inspections in which the same processes within the quality management system at the inspected production site were inspected.
The term "repeated" means that the specific non-conformity was identified during one of the 2 most recent production inspections in which the same quality management system processes at the inspected production site were inspected.

III. Incremental points

The quantitative value of the degree of non-conformity obtained in Stage I is refined in Stage II by applying increasing points for the following non-conformities:
lack of documented procedures related to the processes of design, development, production and output control of the medical device, as well as post-sale monitoring necessary to ensure the safety and efficacy of the medical device;
release of a substandard medical device into circulation during the reporting period. If the manufacturer of a medical device has conducted an unscheduled inspection of production in order to confirm the elimination of the causes that led to the release of a substandard product, the increasing point shall not be awarded.
In this case, 1 point is added to the score obtained at Stage I for each nonconformity.

IV. Form of presentation of the results of the integrated assessment

the significance of the discrepancies

The results of the integral assessment of the degree of significance of non-compliance

are presented in the form of a table:

The inspecting organization shall not issue a positive determination of a medical device manufacturer's compliance with these Requirements if one or more violations are scored 5 or 6 or more than two violations are scored 4.

Annex N 4

to the Requirements for implementation, maintenance

and evaluation of the management system

medical device quality

depending on the potential

application risks

(form)

REPORT

on the results of the initial inspection of production

Annex N 5

to the Requirements for implementation, maintenance

and evaluation of the management system

medical device quality

depending on the potential

application risks

REQUIREMENTS

TO THE CONTENT OF THE TECHNICAL FILE FOR A MEDICAL DEVICE

FOR IN VITRO DIAGNOSTICS

I. General requirements to the content of the technical file

for an in vitro diagnostic medical device

(1) The technical file shall contain the following information about the in vitro diagnostic medical device:
(a) Name of the product;
b) type of product in accordance with the nomenclature of medical devices applicable within the Eurasian Economic Union;
c) class of potential risk of use and applicable classification rules in accordance with the Rules of classification of medical devices depending on the potential risk of use, approved by the Decision of the Board of the Eurasian Economic Commission of December 22, 2015 N 173;
d) the purpose of the product, including (if applicable):
A description of the target analyte, including an indication of the qualitative, semi-quantitative, or quantitative type of determination;
functional purpose;
The specific pathology, condition or risk factor that the product is designed to detect, identify or differentiate;
the type of sample to be analyzed;
potential users;
e) a description of the principle of the analytical method or the principle of operation of the instrument;
(e) A description of the component parts, including a list of possible versions of the product under consideration;
g) description of accessories, other products (including medical devices), which are supposed to be used in combination with the product;
h) description of materials for sample collection and transportation or description (characteristics) of materials recommended for this purpose;
(i) For analytical equipment, technical specifications.
2. In the case of using information on similar or previous modifications of a medical device for in vitro diagnostics in order to prove its compliance with the General Requirements for Safety and Effectiveness of Medical Devices, requirements for their labeling and operational documentation for them, approved by the Decision of the Council of the Eurasian Economic Commission dated February 12, 2016. N 27 (hereinafter - the General Requirements of Safety and Effectiveness), the technical file must contain a brief description:
a) previous modifications of the product under consideration (if any);
b) similar modifications of medical devices in circulation within the Eurasian Economic Union and on international markets.

II. Accompanying information

3. the Technical File shall contain:
a) data on the labeling of the in vitro diagnostic medical device and its packaging;
b) instructions for use (operational documentation) of the medical device for in vitro diagnostics (if available).

III. Information on compliance with the General Safety Requirements

and efficiency

(4) The technical file shall include a checklist for compliance with the General Safety and Performance Requirements in accordance with Annex N 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 the ways to manage these risks in order to reduce them to an acceptable level.

V. Design and development of a medical device

for in vitro diagnostics

6. The technical file should contain information on the main stages of the design of the in vitro diagnostic medical device under consideration. This information may be presented in the form of a flowchart of the processes.

VI. Production processes

7. The technical file shall contain information on manufacturing processes, including 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 flowchart of the processes.

VII. Production sites

8. The technical file shall contain information on the production sites where the in vitro diagnostic medical device under consideration is manufactured. If these sites have quality management system certificates or equivalent documents, their copies shall be attached to the technical file.

VIII. Verification and validation activities

9. The technical file shall contain the following information and verification and validation documents used to demonstrate compliance of the in vitro diagnostic medical device with the General Safety and Effectiveness Requirements:
(a) A list of the standards applied by the manufacturer of the medical device;
b) results of tests in testing laboratories (centers);
c) results of laboratory and (or) factory tests;
d) declaration of conformity to the standards from the list of standards, as a result of application of which on a voluntary basis fully or partially ensures compliance of the in vitro diagnostic medical device with the General Safety and Effectiveness Requirements;
e) declarations of conformity to standards that are not included in the list specified in subparagraph "d" of this paragraph (with justification of their application);
(e) A review of the published literature as it relates to the in vitro diagnostic medical device or similar medical devices under consideration;
g) clinical evidence of the efficacy 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 in vitro diagnostic medical device (if applicable):
(a) Analytical sensitivity (detection threshold);
b) analytical specificity;
c) correctness of definitions;
d) random error;
e) data on metrological traceability of values of calibrators and control materials;
(e) Data on the analytical range (range of linearity - for linear analytical systems), as well as a description of characterization methods;
g) data on the determination of the cut-off point, including details of the characterization method;
h) population (demographic) aspects of the use of a medical device for in vitro diagnostics.
11. The technical file should include information on the scientific validity of the analyte (if applicable).
12. The technical file shall contain information on the clinical efficacy of the in vitro diagnostic medical device, 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 in vitro diagnostic medical device is manufactured in sterile form, a description of the sterilization method, including a validation report on the sterilization process, shall be provided.
15. The technical file shall include a summary of the results of the software verification and validation activities performed at the manufacturing organization.

Annex N 6

to the Requirements for implementation, maintenance

and evaluation of the management system

medical device quality

depending on the potential

application risks

(form)

REPORT

on the results of periodic (scheduled)

production inspections

Annex N 8

to the Requirements for implementation, maintenance

and evaluation of the management system

medical device quality

depending on the potential

application risks

EVALUATION

OF THE QUALITY MANAGEMENT SYSTEM FOR MEDICAL DEVICES, CONDUCTED BY

BY MEANS OF REMOTE INTERACTION

List of amending documents

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

from 12.11.2021 N 131)

1. It is allowed, by decision of the authorized body, to conduct an assessment of the quality management system of a medical device using means of remote interaction (e.g., by video link) in accordance with acts within the law of the Eurasian Economic Union in the following cases:
a) threat of occurrence, emergence and liquidation of an emergency situation and (or) emergence of a threat of spread of epidemic diseases that pose a danger to others, diseases and lesions resulting from the impact of unfavorable chemical, biological, radiation factors;
b) occurrence of force majeure circumstances or circumstances beyond the control of the parties, which pose a threat of harm to the life and health of inspectors.
2. Before starting the evaluation of the medical device quality management system conducted using remote communication means, the manufacturer shall confirm the geolocation data (latitude, longitude) of the location of the production site.
3. For the assessment of the medical device quality management system conducted using remote interaction means, the manufacturer shall provide the documents and information specified in the table.

Table