Decision No. 106 of the Council of the Eurasian Economic Commission dated November 10, 2017
Decision No. 106 of the Council of the Eurasian Economic Commission dated November 10, 2017 “On Requirements for the Implementation, Maintenance and Evaluation of the Medical Device Management System Depending on Potential Risk of Use”
In accordance with clause 2 of Article 31 of the Treaty on the Eurasian Economic Union dated May 29, 2014, clause 1 of Article 6 of the Agreement on Common Principles and Rules for the Circulation of Medical Devices (Medical Devices and Medical Equipment) within the Eurasian Economic Union dated December 23, 2014, clause 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 dated December 23, 2014, and in order to implement Decision No. 109 of the Supreme Eurasian Economic Council dated December 23, 2014 “On Implementation of the Agreement on Common Principles and Rules for the Circulation of Medical Devices (Medical Devices and Medical Equipment) within the Eurasian Economic Union”, the Council of the Eurasian Economic Commission has ruled:
1. To approve the attached Requirements for the Implementation, Maintenance and Evaluation of the Medical Device Quality Management System Depending on Potential Risk of Use (hereinafter referred to asthe “Requirements”).
2. To establish that:
a) within 12 months from the effective date of this Decision:
the quality management system of the manufacturer of a medical device shall not be evaluated for compliance with the Requirements;
when submitting an application for the registration of a medical device of class 2a (for medical devices manufactured in sterilized form), 2b or 3 of their potential risk of use, the registration dossier shall include documents confirming that the manufacturer of the medical device provides production conditions required for the registration of the medical device complying with the requirements of the legislation of a Member State of the Eurasian Economic Union, to the competent authority of which the specified application is submitted (wherever required), and copies of certificates of compliance of the quality management system with 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 of previous inspections for compliance with ISO 13485 standard (if applicable);
b) manufacturers of medical devices registered within 12 months from the effective date of this Decision in accordance with the Rules for Registration and Examination of the Safety, Quality and Efficiency of Medical Devices approved by Decision46 of the Council of the Eurasian Economic Commission dated February 12, 2016, shall confirm the implementation of a quality management system during the unplanned production inspection in accordance with the Requirements within 2 years from thedate of the medical device’s registration;
c) paragraphs 3 and 4 of clause 3 of the Requirements shall come into force from the effective date of the provisions on the introduction of relevant changes to the Rules for Registration and Examination of the Safety, Quality and Efficiency of Medical Devices approved by Decision 46 of the Council of the Eurasian Economic Commission dated February 12, 2016.
3. The state authority of a Member State of the Eurasian Economic Union, authorized to implement and/or coordinate activities in the field of the circulation of medical devices on the territory of this state, shall authorize inspecting organizations to inspect the manufacturers of medical devices in accordance with the requirements for such organizations approved by the Eurasian Economic Commission.
4. This Decision shall enter into force upon 10 calendar days from the date of its official publication.
Members of the Council of the Eurasian Economic Commission:
For the Republic of Armenia
V. Gabrielyan
For the Republic of Belarus
V. Matyushevskiy
For the Republic of Kazakhstan
A. Mamin
For the Kyrgyz Republic
T. Abdygulov
For the Russian Federation
I. Shuvalov
APPROVED
by Decision No. 106
of the Council of the Eurasian
Economic Commission
dated November 10, 2017
Requirements for the implementation, maintenance and evaluation of the medical device quality management system depending on potential risk of use
I. General Provisions
1. These Requirements were developed in accordance with clause 2 of Article 31 of the Treaty ontheEurasian Economic Union dated May 29,
2014 and clause 1 of Article 6 of the Agreement on Common Principles and Rules for the Circulation of Medical Devices (Medical Devices and Medical Equipment) within the Eurasian Economic Union dated December 23, 2014, and establish requirements for the implementation, maintenance and evaluation of the medical device quality management system depending on potential risk of use within the Eurasian Economic Union (hereinafter referred to as the “Union”).
2. For the purposes of these Requirements, the concepts used shall have the following meanings:
“production inspection” is the assessment of production conditions and quality management system of the manufacturer of the medical device for compliance with these Requirements;
“inspecting organization” is an authorized body or organization (organizations) that was granted powers by the competent authority of the Member State of the Union to conduct production inspections;
“corrective action” is an action taken by the manufacturer of medical devices to eliminate the cause of the detected non-compliance or undesirable event;
“correction” is an action taken to eliminate the identified non-compliance;
“critical supplier” is a supplier whose products or services have a direct impact on the safety and/or efficiency of the medical device;
“substandard medical device” is a medical device that does not meet the general requirements for the safety and efficiency of medical devices, requirements for their marking, technical and operational documentation for them, and cannot be safely used for the intended purpose determined by the manufacturer;
“evaluation of the medical device quality management system” is the confirmation of the implementation, maintenance and efficiency 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 efficiency of medical devices, requirements for their marking, technical and operational documentation for them, approved by Decision No. 27 of the Council of the Eurasian
Economic Commission dated February 12, 2016;
“after-sales monitoring” is a system for the collection and analysis of the data of a medical device manufacturer on the use of medical devices, tracking and identification of side effects of
medical devices during their operation;
“preventive action” is an action taken to eliminate the cause of a potential non-conformity or potentially undesirable situation;
“production site” is a territorially separated complex designed to perform the entire process of a medical device’s manufacture or its specific stages;
“medical device quality management system” is the organizational structure, functions,
procedures, processes and resources necessary for coordinated activities aimed at the quality-related administration and management of an organization that manufactures medical devices;
“competent authority” is the state body of a Member State of the Union authorized to implement and/or coordinate activities in the field of the circulation of medical devices on the territory of that state;
“production conditions” are the infrastructure and production environment necessary to ensure compliance of the manufactured medical devices with the General Requirements for the Safety and Efficiency of Medical Products, Requirements for Their Marking, Technical and Operational Documentation, approved by Decision No. 27 of the Council of the Eurasian Economic Commission dated February 12, 2016.
II. Requirements for the medical devices
quality management system depending on potential risk of use
3. Manufacturers of medical devices (with the exception of manufacturers of medical devices of class 1 of potential risk of use and non-sterile medical devices of class 2a of potential risk of use) shall implement a medical device quality management system depending on the class of potential risk of use prior to the submission of documents for marketing authorization.
Manufacturers of medical devices of class 1 of potential risk of use and non-sterile medical devices of class 2a of potential risk of use have the right to implement and maintain a medical device quality management system.
GARANT:
Paragraph 3 shall come into force from the effective date of the provisions on the introduction of relevant changes to the Rules for the Registration and Examination of the Safety, Quality and Efficiency of Medical Devices approved by Decision No. 46 of the Council of the Eurasian Economic Commission dated February 12, 2016
If manufacturers of medical devices of class 1 of potential risk of use and non-sterile medical devices of class 2a of potential risk of use have passed the medical device quality management system assessment, including design and development processes, in accordance with these Requirements, then during the period of validity of the declaration contained in the report on the results of the production inspection, the introduction of changes to the registration dossier of such medical devices shall be made on a notification basis and without any examination of safety, quality and efficiency.
GARANT:
Paragraph 4 shall come into force from the effective date of the provisions on the introduction of relevant changes to the Rules for the Registration and Examination of the Safety, Quality and Efficiency of Medical Devices approved by Decision No. 46 of the Council of the Eurasian Economic Commission dated February 12, 2016
The manufacturer of the medical device shall notify the competent authority that issued the registration certificate for the medical device of the introduction of changes into the registration dossier submitted for registration of a medical device within 2 months of such changes in accordance with Annex No. 7 to the Rules for the Registration and Examination of the Safety, Quality and Efficiency of Medical Devices approved by Decision no. 46 of the Council of the Eurasian Economic Commission dated February 12, 2016.
4. Manufacturers of medical devices of classes 2a (for medical devices manufactured in sterile form) and 2b of potential risk of use shall implement a medical device quality management system (except for the implementation of design and development processes) prior to the submission of documents for marketing authorization of medical devices.
5. Manufacturers of medical devices of class 3 of potential risk of use shall implement a medical device quality management system, including design and development processes, prior to the submission of documents for the marketing authorization of medical devices.
6. The medical device quality management system must ensure compliance of medical products released into circulation within the Union with the applicable General Requirements for
the Safety and Efficiency of Medical Devices, Requirements for Their Marking, Technical and Operational Documentation, approved by Decision No. 27 of the Council of the Eurasian Economic Commission dated February 12, 2016 (hereinafter referred to as the “General Requirements for Safety and Efficiency”).
7. In order to implement a medical device quality management system, the manufacturer of medical devices is obliged to:
a) develop documented risk management requirements for all phases of the life cycle of a medical device;
b) determine processes necessary to ensure the effective functioning of the medical device quality management system (hereinafter referred to as the “Processes”), and implement these processes within the organization manufacturing medical devices;
c) determine the sequence and relationship of the processes;
d) determine the criteria and methods necessary to ensure effectiveness, both during the implementation and management of the processes;
e) ensure availability of the production conditions, resources and information required to support and monitor the processes;
f) monitor, measure (where applicable) and analyze the processes;
g) take measures necessary to achieve the planned results and maintain the effectiveness of the processes.
8. All elements of the medical device quality management system (organizational structure, methods and description of processes) shall be documented and kept up-to-date.
The documentation of the medical device quality management system shall be drawn up in hard copy, and in case the legislation of a Member State of the Union (hereinafter referred to as the “Member State”) provides for the possibility of drawing up the afore-mentioned documentation in electronic form, in electronic format. Such documentation shall be submitted in Russian or shall be accompanied by an authentic translation into Russian certified by the manufacturer in the manner established by the legislation of the Member State.
9. The documentation of the medical device quality management system should include a description of:
a) requirements for the technical characteristics of the medical device, standards or individual sections (paragraphs, subparagraphs) of the standards to be applied, and in the event that the relevant standards are not applied, of the methods which will be used to ensure that the General Requirements for Safety and Efficiency applicable to the manufactured medical devices will be met;
b) methods and degree of monitoring of a third party in the event that the development, production and/or final check are performed by a third party;
c) processes of the production, quality monitoring and assurance of the medical device, processes and systematic measures that will be used to monitor and ensure the quality of the medical device, including processes of corrective and preventive actions;
d) documentation of the medical device’s quality indicators (reports on internal checks, inspections, test results and other documents);
e) means to control assurance of the required quality of the medical device and effective functioning of the medical device’s quality system;
f) plans, procedures and documents of feedback from consumers (including after-sales monitoring of the safety and efficiency of the medical device).
10. Manufacturers of medical devices who have implemented the medical device quality management system in accordance with these Requirements should keep it up-to-date and ensure its effectiveness.
III. Requirements for evaluation of the medical device quality management system
11. Evaluation of the medical device quality management system shall be done by inspecting organizations in the form of a production inspection.
12. The costs associated with the production inspection performed within the framework of the evaluation of the medical device quality management system shall be borne by the manufacturer of the medical device on the basis of a contract concluded with the inspecting organization. The tariffs for conducting the production inspection shall be established in accordance with the legislation of Member States.
The standard duration of the production inspection shall be calculated according to Annex No. 1.
13. The inspecting organization shall have no interest in the results of the production
inspection.
The inspecting organization, its management and employees involved in the production inspection should not take part in activities that may affect the objectivity of their judgments or
their impartiality with regard to the results of the production inspection, they also should not be developers, manufacturers, suppliers of medical devices, should not perform maintenance (repair) of medical devices which they evaluate, or should not be authorized representatives of the developer, manufacturer, supplier of medical devices, or parties performing maintenance (repair) of medical devices.
14. The inspecting organization shall document processes that cover:
a) processing of the request for the production inspection received from the manufacturer of the medical device;
b) planning, conducting and preparing a report of the production inspection;
c) the terms of the contract for the production inspection, concluded with the manufacturer of the medical device or its authorized representative;
d) determination of the production sites that will be subject to production inspection;
e) production of reports of compliance or non-compliance of the medical device quality management system with these Requirements;
f) monitoring of corrective actions to eliminate inconsistencies identified during the production inspection;
g) allocation of responsibilities and powers between the inspection team members for production inspection (considering their competence) and, if necessary, involvement of external experts.
15. The inspecting organization shall develop and implement procedures for the initial determination of the inspectors’ competence upon their appointment and continued maintenance of that competence.
Inspectors should have a diploma of higher education with a specialization in medicine, natural sciences or engineering, at least 3 years experience in the field of assessment of the safety, quality and efficiency of medical devices and/or state supervision of the circulation of medical devices, and must possess knowledge of:
production processes and technologies that are used by the manufacturers of medical devices;
requirements for the safety and efficiency of medical devices, technologies and risks of their medical application;
standards of the medical device quality management system and the medical device risk management system;
fundamentals of the theory of probability and statistics (including methods to determine levels of confidence in a representative sample and regression analysis).
The competence of the inspectors specified in paragraphs 3 and 4 of this clause
shall be confirmed for the subgroups of medical devices listed in Annex No. 2. The inspecting organization should document the areas of competence of its inspectors. Records of inspectors’ areas of competence must be kept up to date and taken into account when appointing inspectors to inspect the production of the relevant medical devices.
The inspecting organization must check the professional level of inspectors in order to confirm their competence by qualification and subsequent re-qualification at least once every 3 years.
16. The inspecting organization should implement a documented procedure to ensure confidentiality of information that constitutes a trade secret and is obtained during inspections, taking into account the possibility of involvement of external experts and participation of inspectors (experts) from the competent authorities.
The confidentiality agreement concluded between the inspecting organization and the manufacturer of medical devices shall contain provisions on the possibility to submit materials of the results of the inspection to the competent authority, as well as any other authorized bodies, that are bound by confidentiality agreements.
17. The inspecting organization shall maintain and retain for at least 10 years any records of inspections and other activities for all manufacturers of medical devices who have applied for and/or passed the production inspection, which should contain the following information:
a) information about the application and reports of the results of the production inspection;
b) contract for the production inspection;
c) justification of the duration of the production inspection;
d) monitoring of the implementation of corrective actions based on the results of inspections;
e) records of complaints and appeals, as well as of subsequent corrective actions;
f) documents certifying 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 competent authorities perform the role of inspecting organizations) shall be carried out by the competent authority for each subgroup of medical devices according to the list contained in Annex No. 2 to these Requirements based on the assessment of their compliance with these Requirements.
The competent authority shall determine the number of inspecting organizations for conducting production inspections at the request of manufacturers of medical devices and/or in accordance with production inspection schedules within a period not exceeding 3 months from the date of submission of the complete set of documentation by the manufacturer of medical devices, including documents of payment for the production inspection.
The list of inspecting organizations shall be posted on the websites of the competent authorities on the information and telecommunications network Internet (hereinafter referred to as the “Internet”) and published on the information portal of the Union.
Within 3 working days from the date of introduction of changes to the information contained in the list of inspecting organizations, the competent authorities shall post the relevant information on their official websites on the Internet and submit it to the Eurasian Economic Commission through the integrated information system of the Union.
19. The competent authority shall audit the inspecting organizations for compliance with these Requirements at least once every 2 years, except for cases when the competent authorities perform the role of inspecting organizations. The competent authorities shall post schedules of the audit of the inspecting organizations on their official websites on the Internet that should be available to the inspecting organizations and authorized bodies no later than 3 months prior to the start of the audit.
If a competent authority performs the role of an inspecting organization, monitoring of its activities shall be done in the manner established by the legislation of the Member State.
Powers of the inspecting organization may be withdrawn by the competent authority, should the audit establish that the inspecting organization does not comply with these Requirements.
The competent authorities have the right to send (at their own expense) their representatives to participate in the audit of the inspecting organization as inspectors (experts), except for cases where the competent authorities perform the functions of inspecting organizations. Based on the results of the audit, the inspector (expert) shall submit written comments and suggestions to the competent authority conducting the audit.
20. Within the framework of coordinating works in the field of administration of inspections, and the development of mechanisms of mutual expert evaluation, the competent authorities have the right (at their own expense) to send their inspectors (experts) to participate in the production inspection as part of the evaluation of the medical device quality management system. The manufacturer of the medical device shall provide access for the members of the inspection (expert) team to the facilities for inspection.
21. Reports of the results of the production inspection shall be sent by the inspecting organization to the competent authority for inclusion in the registration dossier by registered mail with proof of delivery or transmitted in the form of an electronic document with a digital signature within 15 working days from the date of completion of the production inspection.
22. The inspecting organization conducting the production inspection shall not issue a favorable opinion if the medical device quality management system does not comply with these Requirements or is not kept up-to-date.
An integral assessment of the seriousness of non-conformity of the medical device quality management system with these Requirements identified during the production inspection shall be done in accordance with Annex No. 3.
Non-conformities identified based on the results of the production inspection should be eliminated by the manufacturer of the medical device during the production inspection or within a period of no more than 30 working days from the date of completion of the production inspection.
23. If the manufacturer of a medical device does not agree with the unfavorable opinion or identified non-conformities, it shall file a claim with the inspecting organization within 30 working days from the date of receipt by the inspecting organization of a copy of the report of the results of the production inspection. The inspecting organization shall consider this claim and send its reply within 15 working days from the date of its receipt. In the event of failure to reach an agreement, the manufacturer of the medical product can file a complaint in court at the domicile of the inspecting organization or with the competent authority that authorized this organization to evaluate the medical device quality management systems. If the manufacturer of the medical device does not agree with the decision of the competent authority, it has the right to appeal against this decision in court at the domicile of the competent authority.
If the manufacturer of the medical device fails to eliminate the non-conformities or violates the deadlines set for their elimination, the inspecting organization shall inform the competent authority which authorized it to conduct an assessment of the medical device quality management systems.
Unless the manufacturer of the medical device eliminates the non-conformities mentioned in the report of the production inspection, the competent authority has the right to suspend the release of the medical device into circulation on the territory of the Member State in accordance with the legislation of that state. In this case, the competent authority shall inform the competent authorities of other Member States of the suspension of release of the medical device into circulation on the territory of the Member State through the integrated information system of the Union.
24. The production inspection includes assessment of the medical device quality
management system for the following processes:
design and development processes, if they are included in the manufacturer’s medical device quality management system;
document and record management processes;
production and final check processes;
corrective and preventive actions processes;
consumer-related processes.
If the manufacturer of the medical device has implemented a medical device quality
management system in accordance with the standards equivalent to international standard ISO 13485, then proof of compliance of the quality management system with the requirements of these standards (certificate of compliance, audit reports for the medical device quality management system) shall ensure its compliance with these Requirements in terms of processes and procedures related to the functioning of the medical
device quality management system. In this case, the audit shall be limited to the verification of compliance with the requirements related to the processes of design, development, production and final check of the medical device and consumer-related processes (in terms of after sales monitoring).
25. Evaluation of the design and development processes of the medical device quality management system 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 the medical device;
c) based on selected medical device design records, confirmation that design and development procedures have been established and applied;
d) confirmation that design input data have been developed in accordance with the intended use of the medical device and the relevant provisions of General Requirements for Safety and Efficiency;
e) analysis of the medical device’s specifications to confirm that design output data of the medical device, which ensure the safety and efficiency of the medical device when used for its intended purpose, have been defined;
f) confirmation that risk management activities have been defined and implemented, risk acceptance criteria have been established and are appropriate, any residual risk has been assessed and, if necessary, disclosed to the consumer in accordance with the General Requirements for Safety and Efficiency.
26. Evaluation of documentation and record management processes of the medical device quality management system includes:
a) confirmation that procedures for identification, retention and disposal (destruction) of documents and records (including change management) have been defined;
b) confirmation of the availability of documents required for planning, implementation and management of production processes by the organization;
c) confirmation that the medical device’s documentation includes:
certificates of compliance of medical devices with the established requirements (including the requirements of applicable standards);
description of medical devices, including instructions for use, materials and specifications;
summary documentation on the verification and validation of projects (including data of clinical trials (studies) in accordance with the Rules for Clinical and Laboratory Trials (Studies) of Medical Devices approved by Decision No. 29 of the Council of the Eurasian Economic Commission dated February 12, 2016);
marking of medical devices;
risk management documents.
27. Evaluation of production processes and final check of medical devices includes:
a) analysis of production processes for serial production (including production conditions);
b) evaluation of sterilization processes (for medical devices manufactured in sterile form), including:
determination that sterilization processes have been documented, records of sterilization process parameters for each sterilized batch of medical devices are kept up-to-date;
determination of validation of the sterilization process;
determination that the sterilization process is carried out in accordance with the established parameters;
c) confirmation that production processes are monitored and controlled, and operate within the established limits, as well as confirmation of the adequate level of monitoring of products and/or services of critical suppliers;
d) confirmation of identification and traceability of medical devices and processes of their production, as well as of their compliance with the established requirements;
e) confirmation that the final check of the medical devices ensures compliance of the medical devices with the established requirements and have been documented.
28. Evaluation of corrective and preventive action procedures of the medical device quality management system includes:
a) confirmation that corrective and preventive action procedures have been defined;
b) confirmation that respective control measures prevent distribution of medical devices whose quality does not comply with the General Requirements for the Safety and Efficiency of Medical Devices;
c) confirmation of the efficiency of corrective and preventive actions;
d) confirmation that the manufacturer of the medical device has developed an effective procedure for issuing and applying medical device safety notices in accordance with the Rules for Monitoring the Safety, Quality and Efficiency of Medical Devices approved by Decision 174 of the Board of the Eurasian Economic Commission dated December 22, 2015 (hereinafter referred to as the “Rules for Monitoring the Safety, Quality and Efficiency 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 the measures necessary to establish communication with consumers in order to perform necessary corrective and preventive actions, has developed a system for the collection and analysis of data on the safety and efficiency of medical devices at the after-sales stage and keeps it up-to-date, and also submits reports on the results of after-sales monitoring of the safety and efficiency of medical devices to the competent authority in accordance with the Rules for Monitoring the Safety, Quality and Efficiency of Medical Devices;
b) confirmation that consumer feedback is analyzed by the manufacturer of the medical device during product life-cycle processes and is used to re-assess the risk and, if necessary, to update the risk management activities.
30. Evaluation of the medical device quality management system is done in the form of initial, periodic (planned) and unplanned production inspection.
31. The initial production inspection takes place in the course of the medical device’s registration within the Union.
32. During the initial production inspection, the inspecting organization examines the production process on 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 contained in Annex No. 2 attached to these Requirements depending on the class of potential risk of use, then the production inspection of this site may cover several groups (subgroups) of medical devices in accordance with the production sites declared by the manufacturer of the medical devices.
33. Based on the results of the initial production inspection, the inspecting organization shall prepare a report in accordance with Annex No. 4. This report shall be valid for 3 years from the date of its issue.
34. The results of the production inspection shall apply to the group (subgroup) of medical devices according to the list contained in Annex No. 2 attached to these Requirements, depending on the class of the potential risk of use of manufactured medical devices. For medical devices of class 1 and 2a of the potential risk of use, the results of the production inspection shall apply to the groups of medical devices. For medical devices of class 2b and 3 of the potential risk of use, the results of production inspection shall apply to the subgroups of medical devices.
When submitting an application for the registration of new names of medical devices manufactured on the production site, which was inspected previously for medical devices of the same group or subgroup according to the list contained in Annex No. 2 attached to these Requirements, the applicant shall submit a copy of the report of the production inspection, conducted no earlier than 3 years prior to the day of submission of the application for the medical device’s registration, together with the documents of the registration dossier.
35. Periodic (planned) production inspection shall be done once every 3 years.
The manufacturer of the medical device has the right to apply to any inspecting organization for a periodic (planned) production inspection within 6 months prior to the expiry of the report of the previous production inspection, and shall submit the following documents:
an application for production inspection indicating medical devices and their groups (subgroups) according to the list contained in Annex No. 2 attached to these Requirements, and production sites included in the scope of inspection;
a certificate of the actual number of employees involved in the processes of the evaluated medical device quality management system;
technical files for medical devices in accordance with Annex No. 3 to the Rules for Clinical
and Laboratory Trials (Studies) of Medical Devices approved by Decision No. 29 of the Council of the Eurasian Economic Commission dated February 12, 2016 (for medical devices for in vitro diagnostics, a technical file that complies with the requirements of Annex No. 5). Technical files shall be submitted in the Russian language, in electronic form and in a searchable format;
a copy of the report of the last production inspection (if applicable);
a copy of the report of the last audit of the medical device quality management system (if applicable) performed by the certification authority (for certified quality management systems).
Should the periodic (planned) production inspection be conducted by an inspecting organization of a different Member State than the state whose competent authority registered the medical devices,
then reports of the results of the periodic (planned) production inspection shall be sent by the competent authority whose inspecting organization conducted the periodic (planned) production inspection to the competent authority that registered the medical device, for inclusion in the
registration dossier. Reports of the results of the periodic (planned) production inspection shall be sent by registered mail with proof of delivery or transmitted in the form of an electronic document with a digital signature within 15 working days from the date of completion of the periodic (planned) production inspection.
36. The inspecting organization shall analyze the submitted documents within 10 working days from the date of submission of the application for periodic (planned) production inspection by the manufacturer of the medical device. If the inspecting organization decides to conduct a periodic (planned) production inspection, it shall conclude an appropriate contract with themanufacturer of the medical device.
Should the inspecting organization decide not to conduct an inspection, it shall notify the manufacturer of the medical device in writing of its refusal to conduct a periodic (planned) production inspection (with an indication of the reasons).
Refusal to conduct a periodic (planned) production inspection may be based on the following grounds:
non-compliance of the submitted set of documents with the list of documents specified in clause 35 of these Requirements;
non-compliance of technical files with the established requirements;
lack of authority of the inspecting organization to conduct inspections of the specified groups (subgroups) of medical devices.
The schedule of the periodic (planned) production inspection shall be posted on the official websites of the competent authorities on the Internet, as well as published on the information portal of the Union.
The competent authorities shall submit relevant information to the Eurasian Economic Commission through the integrated information system of the Union.
37. Periodic (planned) production inspections shall assess:
a) continuing compliance of the medical device quality management system with these Requirements;
b) effectiveness of the medical device quality management system in providing compliance of the medical devices released into circulation within the Union with the General Requirements for Safety and Efficiency applicable to them.
38. A periodic (planned) production inspection shall be conducted at the production sites selected bythe inspecting organization in accordance with sub-clause “d” of clause 14 of these Requirements, ona representative sample of each group or subgroup of the manufactured medical devices, depending on the class of potential risk of use according to the list contained in Annex No. 2 attached to these Requirements, by analyzing documents and records that resulted from the implementation of the relevant documented processes and/or operating procedures of the medical device quality management system, as applied to these medical devices. For medical devices of classes 1 and 2a of potential risk of use, a representative sample of medical devices shall be selected from the group of medical devices according to the list contained in Annex No. 2 attached to these Requirements; for medical devices of classes 2b and 3 of potential risk of use it shall be selected from a subgroup of medical devices according to the list contained in Annex No. 2 attached to these Requirements.
The selection of representative samples of medical devices shall be based on the following criteria: novelty of technical solutions, intended use, production technologies, taking into account the results of previous inspections. Justification for the selection of representative samples of medical devices shall be included in the report of the production inspection.
During periodic (planned) and unplanned production inspections, the inspecting organization selects representative samples of medical devices (implantable, invasive, and medical devices
for in-vitro diagnostics) of class 3 of potential risk of use in order to confirm the compliance of their characteristics with the technical file that ensures the safe use of such medical devices. The medical devices shall be selected on the basis of one model (version) from each subgroup of the manufactured medical devices in accordance with Annex No. 2 attached to these Requirements, in the quantity necessary to conduct relevant tests. The criterion for the selection of representative samples of medical devices shall be the uniformity of the technical solutions, intended use and/or technologies for this subgroup of the manufactured medical devices. In the absence of such samples, a subgroup of medical devices shall be excluded from the scope of inspection.
The inspecting organization shall conduct necessary tests on the specified samples of medical devices or, if the inspecting organization is not accredited to conduct the relevant type of tests, it shall refer the manufacturer to the relevant organizations included in the unified register of authorized organizations that are authorized to conduct tests (studies) of medical devices for the purpose of their registration, within 3 working days from the date of sampling.
The inspecting organization shall submit the results of tests of selected samples of the medical devices to the competent authority within 5 working days from the date of drawing up the corresponding protocol of tests (studies). In the event of the non-conformity of the characteristics of the selected samples of a medical device with the data of the technical file that ensure its safe use, the inspecting organization shall suspend the report of the production inspection. Unless the manufacturer of the medical device eliminates the identified non-conformities, the competent authority is entitled to suspend the release of the medical device into circulation on the territory of the Member State in accordance with the legislation of that state. In this case, it shall inform the competent authorities of other Member States of the suspension of release of the medical device into circulation on the territory of the Member State through the integrated information system of the Union.
39. Based on the results of the periodic (planned) production inspection, the inspecting organization shall prepare a report in accordance with Annex No. 6. This report shall be valid for 3 years from the date of its issue.
40. The manufacturer of the medical devices has the right to apply to the inspecting organization for an unplanned production inspection for the following purposes:
a) introduction of changes to the list of production sites, the list of groups (subgroups) of medical devices covered by the report of the inspection;
b) confirmation of the elimination of non-conformities based on the results of the production inspection;
c) confirmation of the elimination of the causes that led to the manufacture of substandard medical devices, by means of inclusion of the report of the unplanned inspection in the final report of corrective actions in accordance with Annex No. 2 attached to the Rules for Monitoring the Safety, Quality and Efficiency of Medical Products;
d) confirmation of implementation of the medical device quality management system by the manufacturer (if this quality management system was not assessed for compliance with these Requirements).
41. Based on the results of the unplanned production inspection for the purposes specified in subclauses “a” – “c” of clause 40 of these Requirements, the inspecting organization shall prepare a report in accordance with Annex No. 7, for the purposes specified in subclause “d” of clause 40 of these Requirements in accordance with Annex No. 4 attached to these Requirements. This report shall be valid for 3 years from the date of its issue. Planned inspections shall be conducted no later than 3 years from the date of issue of the afore-mentioned report.
Annex No. 1
to the Requirements for the Implementation,
Maintenance and Evaluation
of the Medical Device Quality Management System
Depending on Potential Risk of Use
Rules
for calculating the standard duration
of the production inspection
1. The standard duration of the production inspection shall be calculated within the process of determining the cost of the production inspection, regardless of the actual duration of the production inspection.
2. The standard duration of the production inspection shall be calculated in man-days on the basis of an 8-hour working day. The standard duration of the production inspection includes the time spent outside the premises of the inspected organization and spent analyzing documentation and planning the production inspection, as well as the time spent directly on the premises of the inspected organization and spent on reporting.
If production inspection sites are located in another city than the inspecting organization, the standard duration of the production inspection shall be increased by 2 man-days for each inspection site.
3. The actual number of employees of the inspected organization participating in the
processes within the evaluated quality management system shall be used as a basis for calculating the standard duration of the production inspection. The number of part-time employees shall be counted by converting it to the equivalent number of full-time employees.
4. The standard duration of the production inspection, depending on the actual number of employees on the inspection site, is shown in the Table below.
Table
| Actual number of employees
(persons) |
Standard duration of initial
production inspection (man-days) |
Standard duration of periodic (planned) production inspection (man-days) |
| 5–49 | 6 | 4 |
| 50–99 | 7 | 5 |
| 100–199 | 8 | 6 |
| 200–499 | 9 | 7 |
| 500–999 | 10 | 8 |
| 1000–1999 | 11 | 9 |
| 2000–4999 | 12 | 10 |
| more than 5000 | 13 | 11 |
Annex No. 2
to the Requirements for the Implementation,
Maintenance and Evaluation
of the Medical Device Quality Management System
Depending on Potential Risk of Use
List
of groups and subgroups of medical devices
| Group of medical devices | Subgroup of medical devices (for classes 2b and 3 of potential risk of use) |
| 1. Non-active medical devices (except for medical devices for in-vitro diagnostics) | 1.1. Non-active cardio-vascular implants |
| 1.2. Non-active orthopedic implants | |
| 1.3. Non-active implants of soft tissues | |
| 1.4. Non-active functional implants | |
| 1.5. Non-active dental implants and dental materials | |
| 1.6. Non-active medical devices for injections, infusions, blood transfusion and dialysis | |
| 1.7. Non-active ophthalmic medical devices | |
| 1.8. Non-active orthopedic medical devices and medical devices for rehabilitation | |
| 1.9. Medical devices for contraception | |
| 1.10. Medical instruments | |
| 1.11. Non-active medical devices for disinfection, hygienic treatment and sterilization of medical devices | |
| 1.12. Suture materials, wound dressing and other medical devices for wound treatment | |
| 1.13. Non-active medical devices not included in subgroups 1.1–1.12 |
|
| 2. Active non-implantable medical devices (except for devices for in-vitro diagnostics) | 2.1. Medical devices to monitor physiological parameters |
| 2.2. Medical devices for imaging using ionizing radiation | |
| 2.3. Medical devices for imaging not using ionizing radiation | |
| 2.4. Medical devices for X-ray therapy using ionizing radiation | |
| 2.5. Medical devices for X-ray therapy not using ionizing radiation | |
| 2.6. Medical devices for lithotripsy | |
| 2.7. Active medical devices for artificial circulation, intravenous infusion and plasmapheresis | |
| 2.8. Active anesthesia-respiratory, hyperbaric medical devices and medical devices for respiratory therapy | |
| 2.9. Active medical devices for stimulation and inhibition | |
| 2.10. Active surgical medical devices | |
| 2.11. Active ophthalmic medical devices | |
| 2.12. Active dental medical devices | |
| 2.13. Active medical devices for the disinfection and sterilization of medical devices | |
| 2.14. Active medical devices for rehabilitation and active prostheses | |
| 2.15. Active medical devices for positioning and transportation of patients | |
| 2.16. Stand-alone medical software | |
| 2.17. Active medical devices for extracorporeal and artificial fertilization | |
| 2.18. Active medical devices not included in subgroups 2.1–2.17 |
|
| 3. Active implantable medical devices | 3.1. Active implantable medical devices for stimulation and inhibition |
| 3.2. Active implantable medical devices for the administration of drugs and other substances | |
| 3.3. Active implantable medical devices supporting, substituting or replacing body functions | |
| 3.4. Radioactive implants for interstitial radiotherapy | |
| 3.5. Active implantable medical devices not included in subgroups 3.1–3.4 |
|
| 4. Medical devices for in-vitro diagnostics | 4.1. Reagents, reagent kits, calibration and control materials |
| 4.2. Devices and equipment for in-vitro diagnostics | |
| 4.3. Stand-alone medical software for in-vitro diagnostics | |
| 4.4. Other medical devices for in-vitro diagnostics not included in subgroups 4.1–4.3 |
Annex No. 3
to the Requirements for the Implementation,
Maintenance and Evaluation
of the Medical Device Quality Management System
Depending on Potential Risk of Use
Integral evaluation
of the seriousness of non-conformities of
the quality management system identified during the production inspection with the Requirements for the Implementation, Maintenance and Evaluation of the Medical Device Quality Management System Depending on Potential Risk of Use
I. Classification of non-conformities
Classification of non-conformities in the quality management system identified during the production inspection with the Requirements for the Implementation, Maintenance and Evaluation of the Medical Device Quality Management System Depending on Potential Risk of Use (hereinafter referred to as the “non-conformities”) shall be done in 2 stages:
Stage I: application of the classification matrix to provide a preliminary assessment of the seriousness of the non-conformities;
Stage II: application of multipliers to determine the final score of the seriousness of the non-conformities.
Multiple non-conformities with the same requirement shall be considered as one non-conformity.
II. Classification matrix
According to the classification matrix, all identified non-conformities shall be divided into 4 groups.
Each group is characterized by a quantitative value of the seriousness of the non-conformity with the requirements for the safety, efficiency and quality of the medical device:
| Impact of the non-conformity on the safety, efficiency and quality of the medical device | direct | 3 | 4 |
| indirect | 1 | 2 | |
| first occurence | repeatedly | ||
| Recurrence of the non-conformity | |||
The classification matrix reflects the impact of the non-conformity on the safety, efficiency and quality of the medical device, as well as its recurrence.
The impact of the non-conformity on the safety, efficiency and quality of the medical device shall be considered indirect if it affects requirements related to the functioning of the medical device quality management system, and direct if it concerns requirements related to the processes of the design, development, production and final check of the medical device.
The term “first occurence” shall mean that a particular non-conformity was not identified during the last 2 production inspections, in which the same processes were reviewed within the quality management system at the inspected site.
The term “repeatedly” shall mean that a particular non-conformity was identified during one of the last 2 production inspections, in which the same processes were reviewed within the quality management system at the inspected site.
III. Multipliers
The quantitative value of the seriousness of the non-conformity obtained at Stage I shall be finalized at Stage II by applying multipliers awarded for the following non-conformities:
lack of documented procedures necessary to ensure the safety and efficiency of a medical device and related to the processes of the design, development, production and final check of the medical device, as well as to after-sales monitoring;
release of a substandard medical device into circulation during the reporting period. If the manufacturer of a medical device has conducted an unplanned production inspection in order to prove the elimination of the causes that led to the production of a substandard device, no multipliers shall be assigned.
In this case, 1 point shall be added to the score obtained at Stage I for each non-conformity.
IV. Form for presenting the results of the integral evaluation of the seriousness of the non-conformities
The results of the integral evaluation of the seriousness of the non-conformities shall be presented in the form of a table:
| Item No. | Non-conformity | Gradation of non-conformity | |||
| Stage I,
score |
Stage II in the
absence of documented processes, score |
Stage II in the event of production of a substandard medical device,
score |
Total score for this non-conformity | ||
| 1 | |||||
| 2 | |||||
Overall score:_______
The inspecting organization shall not issue a favorable opinion on the compliance of the manufacturer of the medical device with these Requirements if one or more non-conformities got a score of 5 or 6 points, or more than two non-conformities got a score of 4 points.
Annex No. 4
to the Requirements for the Implementation,
Maintenance and Evaluation
of the Medical Device Quality Management System
Depending on Potential Risk of Use
(Form)
Report on the results of the initial production inspection
| 1 | Report number | |
| 2 | Organization that conducted the production inspection (full and abbreviated (if applicable) name of the legal entity (including company name), legal structure and address (location)) | |
| 3 | Details of the medical device manufacturer: | |
| 3.1 | Full and abbreviated (if applicable) name of the legal entity (including company name), legal structure and address (location) | |
| 3.2 | Organizational structure and cooperation with legal entities within the framework of the medical device quality management system | |
| 3.3 | List of production sites (including their addresses and manufactured medical devices, approximate number of employees involved in the processes within the evaluated quality management system, as well as contact information) | |
| 3.4 | List of manufactured medical devices designed for circulation within the Eurasian Economic Union | |
| 3.5 | List of groups (subgroups) of medical devices for the production inspection according to the application of the manufacturer of a medical device (including information on the inclusion (non-inclusion) of design and development processes within the scope of the production inspection) | |
| 3.6 | List of critical suppliers
(including addresses, products supplied and services provided, as well as contact information) |
|
| 4 | Details of the production inspection: | |
| 4.1 | Dates of the production inspection, including dates of the onsite production inspection of each inspected site | |
| 4.2 | Members of the inspection team (include the functions of team members, as well as information on the participating interpreters and inspectors (experts), if applicable) | |
| 4.3 | Production inspection plan | |
| 5 | Results of the production inspection (for each inspected site): | |
| 5.1 | General description of inspected activities and/or manufacturing processes | |
| 5.2 | Surnames, names, patronymics (if applicable) and official positions of respondents | |
| 5.3 | Names of medical devices selected for inspection as representative samples, and justification of this choice | |
| 5.4 | Types and quantity of inspected documents and records | |
| 5.5 | List of identified non-conformities of the medical device quality management system with the Requirements for the Implementation, Maintenance and Evaluation of the Medical Device Quality Management System, Depending on Potential Risk of Use |
|
| 5.6 | Information about non-conformities eliminated in the process of the production inspection, deadlines for corrective actions in respect of unresolved non-conformities and forms of confirmation of such actions (submission of supporting documentation or on-site inspection) | |
| 6 | Conclusions: | |
| 6.1 | Declaration of conformity (non-conformity) of the medical device quality management system with the requirements for its implementation (including information on the inclusion (non-inclusion) within the scope of the production inspection of design and development processes for the inspected groups (subgroups) of medical devices) | |
| 7 | Surnames, names, patronymics (if applicable) and official positions of inspectors | |
| 8 | Signatures, seal (if applicable) | |
Annex No. 5
to the Requirements for the Implementation,
Maintenance and Evaluation
of Medical Device Quality Management System
Depending on Potential Risk of Use
Requirements for the contents of the technical file for a medical device
for in-vitro diagnostics
I. General requirements for the contents of the technical file for a medical device
for in-vitro diagnostics
1. The technical file must contain the following information about a medical device for in-vitro diagnostics:
a) product name;
b) product type according to the nomenclature of medical devices used within the Eurasian Economic Union;
с) class of potential risk of use and applicable classification rules in accordance with the
Rules for the Classification of Medical Devices Depending on Potential Risk of Use
approved by Decision No. 173 of the Board of the Eurasian Economic Commission dated
December 22, 2015;
d) product designation, including (if applicable):
description of the target analyte, including qualitative, semi-quantitative or quantitative determination;
functional purpose;
specific pathology, condition or risk factor for detection, determination or differentiation of which the device is designed;
type of sample analyzed;
potential users;
e) description of the principle of the analytical method or operating principle of a product;
f) description of the components, including a list of possible modifications of the device;
g) description of accessories, other products (including medical) that are intended to be used in conjunction with the device;
h) description of the materials for sampling and transportation of samples or description (characteristics) of materials recommended for this purpose;
i) technical specifications for the analytical equipment.
2. When using information on similar or previous modifications of the medical device for in-vitro diagnostics in order to prove its compliance with the General Requirements for the Safety and Efficiency of Medical Devices, requirements for their marking and operational documentation approved by Decision No. 27 of the Council of the Eurasian Economic Commission dated February 12, 2016 (hereinafter referred to as the “General Requirements for Safety and Efficiency”),
the technical file shall contain a brief description of:
a) previous modifications of the device under review (if applicable);
b) similar modifications of medical devices circulating within the Eurasian Economic Union and on international markets.
II. Supporting information
3. The technical file shall contain:
a) data on marking of a medical device for in-vitro diagnostics and its packaging;
b) instructions for use (operational documentation) for a medical device for in-vitro diagnostics (if applicable).
III. Information about compliance with the General Requirements for Safety and Efficiency
4. The technical file shall include a checklist of compliance with the General
Requirements for Safety and Efficiency according to Annex No. 2 to the General Requirements for Safety and Efficiency.
IV. Results of analysis and risk management
5. The technical file must contain a brief list of risks identified during the risk analysis process, and a description of risk management methods applicable in order to mitigate those risks down to an acceptable level.
V. Design and development of a medical device for in-vitro diagnostics
6. The technical file must contain information about the main stages of design of the reviewed medical device for in-vitro diagnostics. This information may be presented in the form of a process flowchart.
VI. Production processes
7. The technical file must contain information about production processes, including production, assembly, final tests and final packaging of the finished medical device for in-vitro diagnostics. This information may be presented in the form of a process flowchart.
VII. Production sites
8. The technical file must contain information about the production sites where the reviewed medical device for in-vitro diagnostics is manufactured. Should these production sites possess certificates of a quality management system or equivalent documents, 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 verification and validation documents that were used to demonstrate compliance of the medical device for in-vitro diagnostics with the General Requirements for Safety and Efficiency:
a) a list of standards applied by the manufacturer of the medical device;
b) results of the tests performed in testing laboratories (centres);
c) results of laboratory and/or factory tests;
d) declarations of compliance with the standards from the list of standards, voluntary application of which ensures full or partial compliance of the medical device for in-vitro diagnostics with the General Requirements for Safety and Efficiency;
e) declarations of compliance with the standards that are not included in the list specified in sub-clause “d” of this clause (including justification for their use);
f) a review of the published literature on the reviewed medical device for in-vitro diagnostics or similar medical devices;
g) clinical proof of the efficiency and safety of the medical device for in-vitro diagnostics.
10. The technical file must contain the following information about the analytical performance of the medical device for in vitro-diagnostics (if applicable):
a) analytical sensitivity (detection threshold);
b) analytical specificity;
c) accuracy of definitions;
d) random error;
e) data on metrological traceability of calibrator values and control materials;
f) data on the analytical range (linearity and range for linear analytical systems), as well as description of methods for the determination of characteristics;
g) data on the definition of a “cut-off point”, including description of details of the method to determine characteristics;
h) population (demographic) aspects of use of the medical device for in-vitro diagnostics.
11. The technical file must contain information about the scientific validity of the analyte (if applicable).
12. The technical file must contain information on the clinical efficiency of the medical device for in-vitro diagnostics, including (if applicable) data on diagnostic sensitivity and diagnostic specificity.
13. The technical file must contain data on the stability of the medical device for in-vitro diagnostics.
14. If the medical device for in-vitro diagnostics is produced in sterile form, please provide a description of the sterilization method, including a report of the sterilization process validation.
15. The technical file must include a summary of the results of the verification and validation of the software performed in the manufacturing organization.
Annex No. 6
to the Requirements for the Implementation,
Maintenance and Evaluation
of the Medical Device Quality Management System
Depending on Potential Risk of Use
(Form)
Report on the results of the periodic (planned) production inspection
| 1 | Report number | |
| 2 | Organization that conducted the production inspection (full and abbreviated (if applicable) name of the legal entity (including company name), legal structure and address (location)) | |
| 3 | Details of the medical device manufacturer: | |
| 3.1 | Full and abbreviated (if applicable) name of the legal entity (including company name), legal structure and address (location) | |
| 3.2 | Organizational structure and cooperation with legal entities within the framework of the medical device quality management system | |
| 3.3 | List of production sites (including their addresses and the manufactured medical devices, approximate number of employees involved in the processes within the evaluated quality management system, as well as contact information) | |
| 3.4 | List of the manufactured medical devices for circulating within the Eurasian Economic Union | |
| 3.5 | List of groups (subgroups) of medical devices according to the previously issued declaration of compliance (including information on the inclusion (non-inclusion) of design and development processes within the scope of the production inspection) | |
| 3.6 | List of critical suppliers
(including addresses, products supplied and services provided, as well as contact information) |
|
| 4 | Details of the production inspection: | |
| 4.1 | Dates of the production inspection, including dates of the onsite production inspection of each inspected site | |
| 4.2 | Members of the inspection team (include the functions of team members, as well as information on the participating interpreters and inspectors (experts), if applicable) | |
| 4.3 | Production inspection plan | |
| 5 | Results of the production inspection (for each inspected site): | |
| 5.1 | General description of inspected activities and/or manufacturing processes | |
| 5.2 | Surnames, names, patronymics (if applicable) and official positions of respondents | |
| 5.3 | Names of medical devices selected for inspection as representative samples, and justification of this choice | |
| 5.4 | Types and quantity of inspected documents and records | |
| 5.5 | List of identified non-conformities of the medical device quality management system with the Requirements for the Implementation, Maintenance and Evaluation of the Medical Device Quality Management System, Depending on Potential Risk of Use |
|
| 5.6 | Information about non-conformities eliminated in the process of the production inspection, deadlines for corrective actions in respect of unresolved non-conformities and forms of confirmation of such actions (submission of supporting documentation or on-site inspection) |
|
| 5.7 | Information on previously identified non-conformities and the results of corrective and/or preventive actions | |
| 6 | Conclusions: | |
| 6.1 | Declaration of conformity (non-conformity) of the medical device quality management system with the requirements to keep it up-to-date | |
| 7 | Surnames, names, patronymics (if applicable) and official positions of inspectors | |
| 8 | Signatures, seal (if applicable) | |
Annex No. 7
to the Requirements for the Implementation,
Maintenance and Evaluation
of Medical Device Quality Management System
Depending on Potential Risk of Use
(Form)
Report on the results of the unplanned production inspection
| 1 | Report number | |
| 2 | Organization that conducted the production inspection (full and abbreviated (if applicable) name of the legal entity (including company name), legal structure and address (location)) | |
| 3 | Details of the medical device manufacturer: | |
| 3.1 | Full and abbreviated (if applicable) name of the legal entity (including company name), legal structure and address (location) | |
| 3.2 | Organizational structure and cooperation with legal entities within the framework of the medical device quality management system | |
| 3.3 | List of production sites (including their addresses and the manufactured medical devices, approximate number of employees involved in the processes within the evaluated quality management system, as well as contact information) | |
| 3.4 | List of the manufactured medical devices for circulating within the Eurasian Economic Union | |
| 3.5 | List of groups (subgroups) of medical devices according to the previously issued declaration of compliance (including information on the inclusion (non-inclusion) of design and development processes within the scope of the production inspection) | |
| 3.6 | List of critical suppliers (including addresses, products supplied and services provided, as well as contact information) | |
| 4 | Details of the production inspection: | |
| 4.1 | Dates of the production inspection, including dates of the onsite production inspection of each inspected site | |
| 4.2 | Members of the inspection team (include the functions of team members, as well as information on the participating interpreters and inspectors (experts), if applicable) | |
| 4.3 | Purpose and objectives of the production inspection | |
| 4.4 | Content and scope of the production inspection | |
| 5 | Results of the production inspection for each inspected site: | |
| 5.1 | General description of inspected activities and/or manufacturing processes | |
| 5.2 | Surnames, names, patronymics (if applicable) and official positions of respondents | |
| 5.3 | Names of the medical devices selected for inspection as representative samples, and justification of this choice considering the purpose of the production inspection | |
| 5.4 | Types and quantity of inspected documents and records | |
| 5.5 | List of identified non-conformities of the medical device quality management system with the Requirements for the Implementation, Maintenance and Evaluation of the Medical Device Quality Management System, Depending on Potential Risk of Use | |
| 5.6 | Information about the non-conformities eliminated in the process of the production inspection, deadlines for corrective actions in respect of unresolved non-conformities and forms of confirmation of such actions considering the purpose of the production inspection | |
| 6 | Conclusions: | |
| 6.1 | Declaration of conformity (non-conformity) of the medical device quality management system with the requirements for its implementation and maintenance considering the purpose of the production inspection | |
| 7 | Surnames, names, patronymics (if applicable) and official positions of inspectors | |
| 8 | Signatures, seal (if applicable) | |