Decision of the Board of the Eurasian Economic Commission dated February 12, 2016 No. 30
"On the Approval of the Procedure for the Formation and Maintenance of the Information System in the Field of Circulation of Medical Devices"
COUNCIL OF THE EURASIAN ECONOMIC COMMISSION
DECISION
dated February 12, 2016. N 30
ON APPROVAL OF THE ORDER
FORMATION AND MAINTENANCE OF AN INFORMATION SYSTEM IN THE SPHERE OF
MEDICAL DEVICES
In accordance with paragraph 2 of Article 31 of the Treaty on the Eurasian Economic Union of May 29, 2014, Article 9 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 112 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 Decision of the Supreme Eurasian Economic Council of December 23, 2014 N 109 "On the implementation of the Eurasian Economic Union".
1. To approve the attached Procedure for the formation and maintenance of an information system in the sphere of medical devices circulation.
2. This Decision shall enter into force upon expiration of 10 calendar days from the date of entry into force of the Protocol signed on December 2, 2015, on the accession of the Republic of Armenia to the Agreement on Uniform Principles and Rules of Circulation of Medical Devices (Medical Devices and Medical Equipment) within the Eurasian Economic Union of December 23, 2014, but not earlier than upon expiration of 10 calendar days from the date of official publication of this Decision.
Members of the Council of the Eurasian Economic Commission:
Approved
By the decision of the Council of the Eurasian
economic commission
dated February 12, 2016. N 30
ORDER
FORMATION AND MAINTENANCE OF AN INFORMATION SYSTEM IN THE SPHERE OF
MEDICAL DEVICES
I. General provisions
1. This Procedure is developed in accordance with paragraph 2 of Article 31 of the Treaty on the Eurasian Economic Union of May 29, 2014 and Article 9 of the Agreement on Uniform Principles and Rules of Circulation of Medical Devices (Medical Devices and Medical Equipment) within the Eurasian Economic Union of December 23, 2014.
2 The information system in the sphere of medical devices circulation (hereinafter referred to as the information system) is intended to create conditions for ensuring the circulation of safe, quality and effective medical devices within the Eurasian Economic Union (hereinafter referred to as the Union).
(3) The information system shall be part of the integrated information system of the Union (hereinafter referred to as the integrated system) and shall include the following information resources:
(a) A single register of medical devices registered within the Union;
b) a unified register of authorized organizations having the right to conduct research (testing) of medical devices for the purposes of their registration;
c) a unified information database for monitoring the safety, quality and effectiveness of medical devices.
4. common information resources of the information system are formed on the basis of information interaction between the member states of the Union and the Eurasian Economic Commission (hereinafter, respectively, the member states, the Commission).
5. For the purposes of this Procedure, the terms used shall mean the following:
"reference state" means the Member State chosen by the applicant, whose authorized body carries out the registration of the medical device;
"authorized body" - a public authority of a Member State, authorized to implement and (or) coordinate activities in the field of circulation of medical devices on the territory of this Member State;
"expert organization" - a legal entity of a Member State to which the authorized body delegated certain functions in the sphere of medical devices circulation, as well as granted the right to obtain access to the data contained in the information system.
6. The Authorized Body using the means of the integrated system:
(a) Submit to the Commission the information necessary for the formation and maintenance of the information system;
b) keep up-to-date the information transferred to them for entering into the general information resources of the information system;
c) carries out information interaction with the authorized bodies of other interested Member States on the implementation of procedures established by the Rules for Registration and Examination of Safety, Quality and Effectiveness of Medical Devices (hereinafter - the Rules for Registration of Medical Devices).
7. The Commission shall publish the information of the open part of the information system on the information portal of the Union in the information and telecommunications network "Internet" (hereinafter referred to as the information portal of the Union, the Internet, respectively).
8. Information interaction between authorized bodies (expert organizations), as well as between authorized bodies (expert organizations) and the Commission in the process of formation, maintenance and use of common information resources shall be carried out through the implementation of common processes within the Union by means of an integrated system.
9. Technological documents regulating information interaction realized within the framework of common processes by means of the integrated system, including requirements to formats and structures of electronic documents and information used in such interaction, shall be developed and approved by the Commission.
10. Access to the information of the common information resources to be published for interested parties shall be provided through the information portal of the Union on a free-of-charge basis.
(11) The integrated system for information interaction with authorized bodies (expert organizations) of other Member States and the Commission shall be used by the authorized body (expert organization) for the following purposes:
(a) Receiving and communicating information about facts and circumstances that pose a threat to human life or health in the use of a medical device;
b) detection in the course of implementation of measures to control the circulation of medical products and monitoring of safety, quality and effectiveness of medical devices of non-compliance of medical devices with the general requirements of safety and effectiveness of medical devices, unjustified use by any manufacturer or its authorized representative of the marking of a medical device with a special mark of circulation of medical devices on the market of the Union, as well as detection of the facts of circulation on the territory of the Member State of the Union of the following medical devices
c) implementation of measures to suspend and (or) ban the use (withdrawal from circulation) of a medical device or measures to notify the manufacturer of a medical device or its authorized representative of the need to conduct an additional expert examination of the medical device;
d) initiation of the procedure for revocation (annulment, withdrawal) of the registration certificate of a medical device;
e) other cases related to the regulation of the circulation of medical devices within the Union.
II. Formation and maintenance of a unified register of medical practitioners
of products registered within the Union
12. The Unified Register of Medical Devices Registered within the Union (hereinafter in this Section and Section III - the Unified Register) contains information on medical devices in circulation within the Union.
13. Formation and maintenance of the unified register shall be carried out by the Commission on the basis of information submitted by authorized bodies using the means of the integrated system.
14. The Unified Register shall contain the following information:
(a) The name of the medical device;
b) names of modifications of the medical device (if any);
c) names of accessories to the medical device (if any);
d) names of accessories to the medical device (if any);
e) names of consumables for the medical device (if any);
(e) date of registration of the medical device;
g) number of the registration certificate of the medical device;
h) the name of the reference State;
i) names of the States of recognition, in the territories of which the circulation of medical device in accordance with its registration certificate is authorized (hereinafter referred to as the States of recognition);
j) status of the registration certificate of the medical device (valid, suspended, canceled, annulled, withdrawn or release of the medical device has been terminated);
k) date of change of the status of the medical device registration certificate (to be filled in if necessary);
m) date of amendments to the registration dossier of the medical device (hereinafter referred to as the registration dossier);
n) code and name of the type of medical device in accordance with the nomenclature of medical devices applied in the Union;
o) class of potential risk of use of the medical device in accordance with the classification of medical devices applied in the Union depending on the potential risk of use;
p) legal form of the medical device manufacturer, full and abbreviated (if any) name of the legal entity, location (surname, name, patronymic (if any), place of residence of a natural person registered as an individual entrepreneur), postal address, telephone and fax numbers, e-mail address and Internet site (if any);
p) organizational and legal form of the authorized representative of the medical device manufacturer, full and abbreviated (if any) name of the legal entity, location (surname, name, patronymic (if any), place of residence of an individual registered as an individual entrepreneur), postal address, telephone and fax numbers, e-mail address and Internet site (if any);
(c) Location and postal address(es) of the production site(s);
t) instructions for use of the medical device (in electronic form);
y) image of the medical device labeling (in electronic form);
f) information on issuance of a duplicate of the registration certificate of the medical device.
III. Information interaction between authorized bodies
(expert organizations) in the course of forming
and maintenance of a unified register
15. Information on medical devices, in respect of which the registration procedure is conducted, as well as materials of registration dossiers, except for instructions for use of registered medical devices and images of their labeling, shall be referred to confidential information, shall be placed in information systems of authorized bodies (expert organizations) and shall be available only to other interested authorized bodies (expert organizations).
Access of authorized bodies (expert organizations) to information contained in the information system of another authorized body (expert organization) shall be carried out by accessing information systems of authorized bodies (expert organizations) using the means of the integrated system.
16. Upon acceptance of an application for registration or an application for amendment of the registration dossier, the authorized body of the reference State assigns an identification number to the application.
The application identification number is indicated alphanumerically and consists of a 2-digit alphabetic code of the reference State, the serial number and the date of acceptance of the application for registration or application for amendment of the registration dossier (in the format dd.mm.yyyyy).
17. Within the framework of the procedure for registration of medical devices for authorized bodies (expert organizations) using the means of the integrated system, access to the following information and documents shall be provided:
(a) The identification number of the registration application;
b) application for registration (in electronic form);
c) registration dossier;
d) expert opinions prepared in accordance with the Rules for Registration of Medical Devices, including research (test) protocols;
e) requests for additional information to be provided by the applicant and responses thereto;
(e) Requests, comments and proposals of the authorized bodies (expert organizations) of the recognition States sent to the authorized body (expert organization) of the reference State and the responses thereto;
g) documents (including reports) on inspections of production of medical devices conducted in the course of expert work;
(h) Information on the stages of consideration of the registration file.
18. When making changes to the registration dossier, the authorized bodies shall exchange the following information and documents using the means of the integrated system:
(a) The identification number of the application for amendment of the registry record;
b) application for amendments to the registration dossier;
c) a set of documents in accordance with the Rules for Registration of Medical Devices;
d) requests, comments and proposals of the authorized bodies (expert organizations) of the states of recognition, sent to the authorized body (expert organization) of the reference state, and answers to them;
(e) Information on the steps in the processing of an application for amendment of the registration file.
19. In order to ensure that all interested authorized bodies (expert organizations) of the states of recognition receive the information necessary for timely exchange of information within the framework of the procedures for registration of medical devices and amendments to registration dossiers, the authorized body of the reference state submits to the Commission, using the means of the integrated system, information on identification numbers of applications for registration of medical devices and applications for amendments to registration dossiers
20. Interaction of the applicant with the authorized body (expert organization) within the framework of the procedures for registration of a medical device and making changes to the registration dossier shall be carried out using the resources of the information system of the authorized body (expert organization) of the reference state.
21. In case of making a decision on registration of a medical device, the authorized body of the reference state within 1 working day:
(a) obtains the serial number of the registration certificate of the medical device in the unified register using the integrated system;
b) enters information into the unified register in accordance with paragraph 14 of this Procedure;
c) notify, using the means of the integrated system, the authorized bodies (expert organizations) of the states of recognition of the registration of the medical device and entry of information about it and relevant documents in the unified register.
22. In case of change of the status of the registration certificate of a medical device, the authorized body (expert organization) of the reference state shall notify the authorized bodies (expert organizations) of the states of recognition using the means of the integrated system.
IV. Formation and maintenance of a unified register of authorized persons
organizations authorized to conduct research
(tests) of medical devices for the purpose of their registration
23. The unified register of authorized organizations having the right to conduct research (testing) of medical devices for the purpose of their registration (hereinafter referred to as the register of authorized organizations) shall contain information on institutions, organizations and enterprises, including medical institutions and organizations, in accordance with the lists of such institutions, organizations and enterprises determined by the authorized bodies.
24. Formation and maintenance of the register of authorized organizations shall be carried out by the Commission on the basis of information submitted by authorized bodies using the means of the integrated system.
25. The register of authorized organizations shall contain:
a) the list of institutions, organizations and enterprises (hereinafter - the list of testing laboratories (centers)):
authorized to conduct technical tests of medical devices and studies (tests) to assess the biological effect of medical devices, accredited in accordance with the established procedure;
having the right to carry out tests for the purpose of type approval of measuring instruments, accredited in accordance with the established procedure or authorized in accordance with the established procedure by the legislation of the Member State in the field of assurance of uniformity of measurements (in respect of medical devices referred to measuring instruments, the list of which is approved by the Commission);
b) a list of medical organizations authorized to conduct clinical and (or) clinical and laboratory studies (tests) of medical devices for the purpose of assessing their safety and clinical effectiveness (hereinafter referred to as the list of medical organizations).
26. The list of testing laboratories (centers) shall contain the following information:
a) organizational and legal form, full and abbreviated (if any) names of the testing laboratory (center);
b) number of accreditation certificate or authorization document;
c) date of issue of accreditation certificate;
d) date of expiry of the accreditation certificate;
e) validity status of the accreditation certificate or authorization document;
f) location (address) of the testing laboratory (center), telephone and fax numbers, e-mail address and Internet site (if available);
g) surname, name, patronymic (if any), contact details of the head of the testing laboratory (center);
h) description of the field of accreditation or authorization document.
27. The list of medical organizations contains the following information:
a) organizational and legal form, full and abbreviated (if any) names of the medical organization;
b) location (address) of the medical organization, telephone and fax numbers, e-mail address and Internet site (if any);
c) surname, name, patronymic (if any), contact details of the head of the medical organization;
d) types of activities of the medical organization;
e) details of the regulatory document on the basis of which the medical organization is allowed to conduct clinical and (or) clinical and laboratory studies (tests) of medical devices.
V. Formation and maintenance of a unified information base
monitoring data on safety, quality
and effectiveness of medical devices
28. The unified information database for monitoring the safety, quality and efficacy of medical devices (hereinafter referred to as the database) contains information on adverse events (incidents) related to medical devices and corrective actions on medical device safety.
29. The formation and maintenance of the database shall be carried out by the Commission on the basis of information submitted by the authorized bodies in electronic form using the means of the integrated system.
30. The database contains the following information:
a) name of the medical device with indication of the factory (serial) number and (or) batch number;
b) details of the registration certificate of the medical device (date, number, expiration date, name of the authorized body of the reference state);
The numbering of subparagraphs is given in accordance with the official text of the document.
d) code and name of the type of medical device in accordance with the nomenclature of medical devices applied in the Union;
e) class of potential risk of use of the medical device in accordance with the classification of medical devices applied in the Union depending on the potential risk of use;
f) legal form of the medical device manufacturer or its authorized representative, full and abbreviated (if any) name of the legal entity, location (surname, name, patronymic (if any), place of residence of a natural person registered as an individual entrepreneur), postal address, telephone and fax numbers, e-mail address and Internet site (if any);
The numbering of subparagraphs is given in accordance with the official text of the document.
h) information on adverse events (incidents): date of the adverse event (incident), description of the adverse event (incident), adverse event (incident) report number of the medical organization-user (if applicable), date of receipt of information on the adverse event (incident) by the manufacturer, number of patients involved (if known), number of medical devices involved (if known), current location of the medical device (if known), user of the medical device at the time of the adversity
The numbering of subparagraphs is given in accordance with the official text of the document.
j) information on corrective actions:
in the initial report - general information and reason for corrective actions, description and justification of actions, recommendations for suppliers (distributors) and users;
in the subsequent report - general information and reason for corrective actions, description and justification of actions, recommendations for suppliers (distributors) and users, process of corrective actions implementation, timeframe for corrective actions implementation;
in the final report - general information and reason for corrective actions, description and justification of actions, recommendations for suppliers (distributors) and users, process of corrective actions implementation, terms of corrective actions implementation;
k) information on the results of the investigation of the adverse event (incident): results of the analysis conducted by the manufacturer of the medical device, assessment of the adverse event (incident) (codes and terms of levels 1 and 2 in accordance with the rules for monitoring the safety, quality and efficacy of medical devices), actions taken and terms of their implementation, final comments of the manufacturer, manufacturer's awareness of similar adverse events (incidents) related to this type of medical device, with the scheme of the medical device, and the results of the investigation of the adverse event (incident).
m) information obtained within the framework of the report on safety and clinical effectiveness of medical devices of potential application risk class 3, as well as medical devices of potential application risk class 2b, implanted in the human body: list of identified residual risks associated with the medical device, goals, objectives and scheme of post-registration clinical monitoring, clinical data obtained during the reporting period (with assessments of clinical data for the reporting period and for the entire period of clinical monitoring).
m) copy of the manufacturer's notification on the safety of the medical device in the form established by the Rules for Monitoring of Safety, Quality and Effectiveness of Medical Devices.
31. Information contained in subparagraphs "h" - "m" of paragraph 30 of this Procedure refers to the closed part, is not subject to publication and is available only for authorized bodies (expert organizations).
