ORDER no. 1113n dated 19 October 2020

MINISTRY OF HEALTHCARE OF THE RUSSIAN FEDERATION

 

ORDER

1113n dated 19 October 2020

On Approval

of the Procedure for reporting by the entities providing the circulation of medical devices on any adverse events not mentioned in the instructions for use or operating manual for the related medical device, adverse reactions during its usage, specific issues related to medical device interactions, and any other related findings which potentially may pose a threat to the life and health of patients and healthcare personnel using or operating medical devices

  

In accordance with part 3 of article 96 of Federal Law dated 21 November 2011 no. 323-FZ “On the Fundamentals of Healthcare of Citizens of the Russian Federation” (Collection of Legislative Acts of the Russian Federation, 2011, no. 48, art. 6724) and subclause 5.2.192 of the Statute on the Ministry of Healthcare of the RF as approved by Decree of the Government of the RF dated 19 June 2012 no. 608 (Collection of Legislative Acts of the Russian Federation, 2012, no. 20, art. 2528), I hereby order:

  1. Approve the attached Procedure for reporting by entities providing the circulation of medical devices on any adverse events not mentioned in the instructions for use or operating manual for the related medical device, adverse reactions during its usage, specific issues related to medical device interactions, and any other related findings which potentially may pose a threat to the life and health of patients and healthcare personnel using or operating medical devices.
  2. This Order becomes effective from 01 January 2021 and is in force until 01 January 2027.

Minister

M.A. Murashko

APPROVED

By order of the Ministry

of Healthcare of the RF no. 1113n

dated 19 October 2020

The Procedure

for reporting by entities providing the circulation of medical devices on any adverse events not mentioned in the instructions for use or operating manual for the related medical device, adverse reactions during its usage, specific issues related to medical device interactions, and any other related findings which potentially may pose a threat to the life and health of patients and healthcare personnel using or operating medical devices

 

  1. This Procedure sets out for entities providing the circulation of medical devices the rules for reporting any adverse events not mentioned in the instructions for use or operating manual for the related medical device, adverse reactions during its usage, specific issues related to medical device interactions, and any other related findings which potentially may pose a threat to the life and health of patients and healthcare personnel using or operating medical devices (hereinafter The Procedure).
  2. Organizations, duly established1 on the territory of the RF, or the representative offices of the foreign organization duly accredited2 on the territory of the RF, or private entrepreneurs registered on the territory of the RF, or individuals responsible for technical tests, toxicological studies, clinical trials, quality, safety and efficiency assessment of medical devices, and for its marketing authorisation, production, manufacturing, import to the RF, export from the RF, compliance certification, state control, storage, transportation, sales, installation, commissioning, usage, operation, including maintenance as provided in the regulative, technical and/or operational documentation of the manufacturer, as well as its repair, recycling or destruction (hereinafter ‘entities providing the circulation of medical devices’) apart from entities providing the circulation of medical devices performing their service on the territory of international medical clusters or on the territory of innovative scientific and technological centers3, shall, within twenty business days from the day of discovery of any adverse events not mentioned in the instructions for use or operating manual for the related medical device, adverse reactions during its usage, specific issues related to medical device interactions, and any other related findings which potentially may pose a threat to the life and health of patients and healthcare personnel using or operating medical devices (hereinafter an adverse event) notify the Federal Service for Overseeing Healthcare (hereinafter The Service) about the adverse event associated with the use of the medical device (please refer to Appendix No. 1 to this Procedure for the recommended template).

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1 Federal Law dated 08 August 2021 no. 129-FZ “On the state registration of legal entities and private entrepreneurs” (Collection of Legislative Acts of the Russian Federation, 2011, no. 33, art. 3431; 2020, no. 31, art. 5048).

2 Article 21 of Federal Law dated 9 July 1999 no. 160-FZ, “On foreign investments in the Russian Federation” (Collection of Legislative Acts of the Russian Federation, 1999, no. 28, art. 3493; 2014, no. 19, art. 2311)

3 Part 5 of Article 38 of Federal Law dated 21 November 2011 no. 323-FZ “On the basic principles of public healthcare in the Russian Federation” (Collection of Legislative Acts of the Russian Federation, 2011, no. 48, art. 6724; 2020, no. 29, art. 4516).

  1. The manufacturer of the medical devices (or its authorised representative) shall provide to the Service a report on the adverse event occurring during the use of the medical device (please refer to Appendix no. 2 to this procedure for the recommended template) (hereinafter the Report on the Adverse Event), and report on the corrective actions related to the safety of the medical device (please refer to Appendix no. 3 to this procedure for the recommended template) (hereinafter the Report on Corrective Actions).

The initial Report on the Adverse Event shall be provided within the following timeline:

  1. a) in the event of a serious threat to the human health — immediately but no later than within 2 calendar days after the manufacturer of the medical device (or its authorised representative) had been informed about such threat;
  2. b) in the event of a lethal outcome or unexpected serious deterioration of the user’s health — immediately after the manufacturer of the medical device (or its authorised representative) had established the causal relationship between the use of the medical device and the event concerned, but no later than 10 calendar days after the manufacturer of the medical device (or its authorised representative) had been informed about such event;
  3. c) in any other adverse events — immediately after the manufacturer of the medical device (or its authorised representative) had established the causal relationship between the use of the medical device and the event concerned, but no later than 30 calendar days after the manufacturer of the medical device (or its authorised representative) had been informed about such event.

The manufacturer of the medical device (or its authorised representative) has the right to perform corrective actions before submitting the initial Report on Corrective Actions to the Service, when this is necessary for the purpose of emergency protection of the users or third parties involved from the risk of a lethal outcome or serious deterioration of health. In that case, the initial Report on Corrective Actions shall be submitted to the Service no later than within 2 calendar days after such corrective actions were performed by the manufacturer of the medical device (or its authorised representative).

If the manufacturer of the medical device (or its authorised representative) has no possibility to investigate the adverse event occurred, it has to notify the Service about this immediately.

The manufacturer of the medical device (or its authorised representative) may ask the Service for assistance in terms of provision of access to the medical device in order to be able to determine the relationship between the adverse event concerned and the medical device.

  1. The medical organizations involved in the circulation of the medical devices (hereinafter the medical organizations) shall, inter alia, inform the manufacturer of the medical device (or its authorised representative) about any events that have indications of the adverse event, or provide access to the medical devices possibly related to the adverse events.
  2. Information about the adverse event associated with the use of medical devices registered in accordance with the legislation of the RF and circulating within the territory of the RF5, except the territory of the international medical cluster or territory of innovative scientific and technological centers, shall be submitted to the Service by the entities providing the circulation of medical devices, including those providing their immediate usage (users, healthcare organizations).

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4 Decrees of the Government of the Russian Federation dated 27 December 2012 no. 1416 “On approving the rules and regulations for the state registration of medical devices” (Collection of Legislative Acts of the Russian Federation, 2013, no. 1, art. 14, 2020, no. 12, art. 1792), dated 3 April 2020 no. 430 “On special aspects of using medical devices, Including the state registration of a series (batch) of a medical device” (Collection of Legislative Acts of the Russian Federation, 2020, no. 15, art. 2284, Official Internet Portal of Legal Information http://www.pravo.gov.ru,). 4 June 2020).

The notifications have to contain true actual information supported by relevant documents, which shall be attached to the Report on the Adverse Event.

The type and variant of the adverse event mentioned in the Report on the Adverse Event shall be structured according to the variants of the adverse events, adverse reactions associated with the use of the medical devices, facts and circumstances posing a threat to human life or health associated with the circulation of medical devices. The recommended guide for appropriate codes and classification of the adverse reactions associated with the use of medical devices, facts and circumstances posing a threat to human life or health associated with the use of medical devices. (hereinafter the Designation System of Adverse Events) is posted on the official web site of the Service on the Internet information and communication network (hereinafter the Internet).

  1. Based on the results of the corrective actions taken, the manufacturer of the medical device (or its authorised representative) shall issue a Safety Notice for the Medical Device (please refer to Appendix no. 4 to this procedure for the recommended template) (hereinafter the Safety Notice), and distribute it to the users of the medical device by posting it on their related official web site on the Internet, and also provide it to the Service for review of the information contained in the Notice and, if necessary, for posting it on the official web site of the Service on the Internet.
  2. In the following cases, Reports on Adverse Events shall not be submitted to the Service:
  3. a) for any individual adverse event of those mentioned in the Safety Notice which had happened after investigation of the initial adverse event by the manufacturer of the medical device (or its authorised representative) and after the distribution of such Notices and implementation of Corrective Actions. Instead of submitting the Reports of Adverse Events in this case, the manufacturer of the medical device (or its authorised representative) may agree with the Service on the possibility of submitting from time to time a summary report for the aforementioned adverse events (as well as agree the scope and schedule for such summary reporting).
  4. b) for each individual adverse event which often occurs and is well documented and described as such in the Risk Analysis pertaining to the medical device in question, when the Reports of Adverse Events were already previously submitted by the manufacturer of the medical device (or its authorised representative) and reviewed by the Service. Scheduled summary reports may be appropriate instead. The scope and time frame for such reporting shall be agreed with the Service.
  5. c) for adverse events related to an obvious defect of the medical device which the user may discover immediately before use of the medical device;
  6. d) for adverse events which do not lead to serious deterioration of health or to death due to the specific design features able to protect the user from such threat in the event of the medical device’s failure;
  7. e) for expected and foreseen adverse events meeting all the above-mentioned criteria:

adverse events mentioned in the operational (accompanying) documentation for the medical device concerned;

adverse events well known in clinical practice, they may be qualitatively and quantitatively predicted when the medical device is used and functioning in accordance with its intended purpose;

adverse events are well documented in the technical documentation of r the medical device along with the risk assessment performed in advance;

adverse events are clinically acceptable as the benefits outweigh the risks for every individual patient;

  1. f) when the risk of death or serious deterioration of health was analysed and found to be negligible, or if no death or serious deterioration of health occurred, and the risk was described and documented as acceptable in the documentation provided as part of the registration dossier during the marketing authorisation process for the medical device.
  2. For medical devices of potential associated risk usage class 3, and for medical devices to be implanted into the human body with the potential associated risk usage class 26, the manufacturer of the medical device (or its authorised representative) shall monitor its safety and clinical efficiency in the post-marketing authorisation period (hereinafter the clinical monitoring) and provide Reports on the Clinical Monitoring to the Service yearly over 3 years (please refer to Appendix No. 5 to this procedure for the recommended template).

Reports on the Clinical Monitoring are to be submitted by the manufacturer of the medical device (or its authorised representative) to the Service no later than 1 February of the year following the year in which the marketing authorisation certificate was issued.

  1. Clinical monitoring has to be performed as per the plan containing the following information:
  2. a) goals and objectives of the Clinical Monitoring considering the available clinical data, specific features and risk factors associated with the medical device;
  3. b) a Clinical Monitoring framework, including a justification of the methods and ways to obtain the clinical data and methods for their statistical analysis, selection of the population being studied, selection basis for the exclusion and inclusion criteria, minimum population size, and, where applicable, the need to have parallel (comparison) groups in the study design.
  4. The Report of an Adverse Event, Adverse Event Notice, Report of Corrective Actions, Safety Notice, and Clinical Monitoring Report all have to be sent in electronic form to the Service via the related automated information service available on the Service’s web-site on the Internet, or via the Service’s mobile app, or via the Federal State Information System “The Single State and Municipal Service (functions)” Portal, or, when the Internet is not available, in paper format.
  5. Organizations mentioned in paragraph 2 of this procedure shall appoint an officer responsible for the medical devices’ safety monitoring (hereinafter the Responsible Officer).

This Responsible Officer has to collect and submit to the Service all information mentioned in paragraphs 3 and 5 of this Procedure, as well as monitor the Service’s information bulletins posted on the Service’s official web site on the Internet; they are also responsible for any actions mentioned in those bulletins as related to the medical devices used within the organization.

Procedures regulating the job tasks and duties of the Responsible Officer in terms of the monitoring of the safety of medical devices are governed by the local regulations valid in the jurisdiction of the related entity providing the medical devices.

  1. Information mentioned in the Adverse Event Notice, shall be registered and processed by the Service in accordance with the Procedure for Safety Monitoring for the Medical Devices, as approved by the Ministry of Healthcare of the RF5.

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5 Clause 5.2.191 of the Charter of the Ministry of Healthcare of the Russian Federation, as approved by Decree of the Government of the Russian Federation dated 19 June 2012 no. 608 (Collection of Legislative Acts of the Russian Federation, 2012, no. 26, art. 3526).

  1. Protection from unauthorized access to the data provided by the entities providing the medical devices to the Service shall be performed in accordance with Federal Law “On information, information technologies and protection of information” dated 27 July 2006 no. 149-FZ6.

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5 Collection of Legislative Acts of the Russian Federation, 2006, no. 31, art. 3448; 2020, no. 14, art. 2035.

Appendix no. 1 to the Procedure

for reporting by the entities providing circulation of the medical devices of any

adverse events not mentioned

in the instructions for use

or operating manual for the related medical device,

adverse reactions during its usage,

specific issues related to the medical device

interactions, and any other related findings

which potentially may pose a threat

to the life and health of patients and healthcare

personnel using or operating medical devices, as approved by the Order

of the Ministry of Healthcare of the RF

  1. 1113n dated 19 October 2020

Recommended template

Report of Adverse Event

occurring during the use of the medical device

  1. Information regarding entities providing the circulation of medical devices:
  2. a) full and (if applicable) short name, including business name, legal form of the legal entity, address of the location or surname, name and patronymic (if applicable), details of the identification document, address of the place of residence of the individual entrepreneur, as well as the phone numbers and e-mail address of the legal entity or individual entrepreneur (if applicable);
  3. b) tax payer identification number;
  4. c) registration number according to the State Register of Legal Entities or Private Entrepreneur registration number;
  5. d) type of organization (organization created on the territory of the RF, or representative office of the foreign company accredited on the territory of the RF, or individual entrepreneurs registered on the territory of the RF).
  6. Information about the medical device associated with the adverse event:
  7. a) name of the medical device, according to the marketing authorisation certificate;
  8. b) number and date of the marketing authorisation certificate;
  9. c) number of the registration certificate issued in the Single Register of Medical Devices registered in the Eurasian Economic Union (if applicable);
  10. d) implementation version, type or model of the medical device, as per the registration certificate;
  11. e) potential risk of usage class;
  12. f) type code and name of the medical device in accordance with the Nomenclature Classification of Medical Devices, as approved by Order of the Ministry of Healthcare of the RF dated 6 June 2012, no. 4n (registered by the Ministry of Justice of the RF on 9 July, 2012, reg. no. 24852)1.

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1 As amended by orders of the Ministry of Healthcare of the Russian Federation dated 25 September 2014, no. 557n (registered by the Ministry of Justice of the RF on 17 December 2014, reg, no. 35201) and dated 7 July 2020, no. 686n (registered by the Ministry of Justice of the RF on 10 August 2020, reg. no. 59225).

  1. g) type code and name of the medical device in accordance with the Nomenclature of Medical Devices, as per the rules approved by a Decision of the Eurasian Economic Committee dated 29 December 2015, no. 1772 (if applicable);
  2. g) reference number in the catalogue of goods, services and work intended to ensure state and municipal needs, as per the Rules for the creation and maintenance of such catalogues of goods, services and work intended to ensure state and municipal needs in the Single State Purchase system, and the Rules for the use of such catalogues, as approved by Decree of the Government of the RF dated 8 February, 2017, no. 1453.
  3. h) name of the manufacturer of the medical device, according to the marketing authorisation certificate;
  4. i) name of the country of origin of the medical device, according to the marketing authorisation certificate;
  5. j) manufacturing address (addresses) of the medical device, according to the marketing authorisation certificate;
  6. k) composition and scope of supply of the medical device (if applicable) and the list of accessories (if applicable), according to the marketing authorisation certificate;
  7. l) batch (lot) number, serial number (if applicable);
  8. m) number of medical devices in circulation (stating the serial number, lot numbers and batch numbers, factory numbers etc.), associated with the adverse event, itemised;
  9. n) date of manufacture (production) of the medical device;
  10. o) expiry date or service life term of the medical device;
  11. p) expiry date of the warranty period, service life, operational period, as set by the manufacturer (if applicable/if provided);
  12. q) full and abbreviated (if applicable) name, including the company name, legal form of the legal entity responsible for distribution and sales of the relevant batch (lot, factory number) of the medical device, its address, or, in the event of an individual entrepreneur, his/her full name (with patronymic, if applicable), home address and ID data (hereinafter the Vendor), as well as the tax identification number, main state registration number in the State Register of Legal Entities, or the state registration number for the individual entrepreneur, his/her phone number and email (if applicable);
  13. r) information regarding the registration number of the Vendor as per the Notification Register of the entities providing circulation of the medical devices (hereinafter the Notification Register)4.
  14. s) name and address of the premises used as storage for the aforementioned batch (lot, factory number, model, variant etc.) of the medical device, as per the Notification Register (if applicable);
  15. t) full and abbreviated (if applicable) name, including the company name, legal form of the legal entity responsible for the application of the relevant batch (lot, factory number) of the medical device in question, its address (stating exact addresses involved in the application of this device), or, in the event of an individual entrepreneur, his/her full name (with patronymic name, if applicable), home address and ID data, as well as tax identification number, main state registration number in the State Register of Legal Entities, or state registration number for the individual entrepreneur, his/her phone number and email

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2 Official site of the Eurasian Economic Union http://www.eaeunion.org/, 31 December 2015.

3 Collection of Legislative Acts of the Russian Federation, 2017, no. 7, art. 1084; no. 28, art. 4421.

4 Paragraph 12 of the Rules for the submission of Notifications regarding the initiation of certain types of businesses, and taking account of such Notifications, as approved by a Decree of the Government of the Russian Federation dated 16 July 2009, no. 584 (Collection of Legislative Acts of the Russian Federation, 2019, no. 30, art. 3823).

of the said legal entity or individual entrepreneur (if applicable)

  1. u) country or name of the administrative region of the RF (if the event occurred in the RF), residential area (city, town etc.) and address of the adverse event occurrence;
  2. v) location of the relevant medical device at the moment of submission of the Notification (recycled, quarantined, transferred to the vendor or manufacturer (or its authorised representative), still in use, other);
  3. w) information obtained from acts, reports, maintenance and other service logs etc. (if applicable);
  4. x) number of medical devices involved in the adverse event (if known).
  5. Event description:
  6. a) Date on which the Notification was sent to the Federal Service for Overseeing Healthcare;
  7. b) type of Notification (primary, follow-up, final);
  8. c) date on which the adverse event had become known to the notifying party;
  9. d) date on which the adverse event occurred;
  10. e) for the implanted medical devices:

Date of implantation

Date of explantation

Length of implantation (when the exact date of implantation or the start date of the operation is known);

Data obtained from the sub-system for conducting specialised registers of patients under separate ICD diseases and citizen categories, from monitoring by an organization for providing high-tech medical aid and health resort treatment, the Single State Information System in Healthcare5, or from other information systems intended for the collection, storage, processing and provision of information concerning the activity of medical organizations and the services they provide , as well as from the federal state information system “The Single Automated Vertically Integrated Information and-Analytical System for the Provision of Socio-Medical Assessment” (if the entity providing circulation of the medical devices has access to any of those systems);

  1. f) registration number of the adverse event, as assigned by the manufacturer (if applicable);
  2. g) The type and variant of the adverse event mentioned in the Report on the Adverse Event shall be structured according to the variants of the adverse events, adverse reactions associated with the use of medical devices, facts and circumstances posing a threat to human life or health associated with the circulation of the medical devices;
  3. h) description of side effects not specified in the medical device’s instructions for use or operating manual, adverse reactions during its use, the possibilities of medical device interaction, the facts and circumstances that may create a danger to the life and health of individuals and medical workers when using and operating medical devices;
  4. i) user of the medical device involved (physician, nurse, patient, other);
  5. j) usage of the medical device (initial, repeated use of a single use medical device, multi-use medical device usage, medical device after maintenance or service; the issue was identified before the start of usage, other);
  6. k) category of the adverse event associated with the use of the medical device involved:

Serious or unexpected side reaction, not stated in the instruction for use

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5 Sub-clause ‘f’ of paragraph 4 of the Statute on the Single State Information System in the Sphere of Healthcare, as approved by Decree of the Government of the Russian Federation dated 5 May 2018 no. 555 “Single State Information System in the Sphere of Healthcare” (Collection of Legislative Acts of the Russian Federation, 2018, no. 20, art. 2849).

or in the user guide for the related medical device;

Side effect associated with the use of the medical device;

Specific interaction of several medical devices;

Substandard quality of the medical device;

Any circumstances posing a hazard to the life and well-being of the general public and health care professionals, associated with the use and/or operation of the medical device;

Any other adverse event issues;

  1. l) measures taken by the user or by the medical organization in order to rectify the adverse event;
  2. Information regarding the affected person:
  3. a) affected person (home stay patient, day care hospital patient, fully hospitalised patient, medical staff, visitor, technical staff, self-care, other);
  4. b) full name (including patronymic, if applicable);
  5. c) gender, age, weight, height (if applicable);
  6. d) severity criteria (harm incurred);
  7. e) outcome;
  8. f) description of the related issue;
  9. g) number of affected persons (if applicable);
  10. h) actions taken and care provided to the affected person by the medical organization.
  11. Additional information and documents.

Appendix no. 2 to the Procedure

for reporting by the entities providing circulation of the medical devices of any

adverse events not mentioned

in the instructions for use

or operating manual for the related medical device,

adverse reactions during its usage,

specific issues related to the medical device

interactions, and any other related findings

which potentially may pose a threat

to the life and health of patients and healthcare

personnel using or operating medical devices, as approved by the Order

of the Ministry of Healthcare of the RF

  1. 1113n dated 19 October 2020

Recommended template

Report on the Adverse Event

occurring during the use of the medical device

  1. Information regarding entities providing the circulation of medical devices:
  2. a) full and (if applicable) short name, including business name, legal form of the legal entity, address of the location or surname, name and patronymic (if applicable), details of the identification document, address of the place of residence of the individual entrepreneur, as well as the phone numbers and e-mail address of the legal entity or individual entrepreneur (if applicable);
  3. b) tax payer identification number,
  4. c) registration number according to the State Register of Legal Entities or Private Entrepreneur registration number;
  5. d) type of organization (organization created on the territory of the RF, or representative office of the foreign company accredited on the territory of the RF, or individual entrepreneurs registered on the territory of the RF).
  6. Information about the medical device associated with the adverse event:
  7. a) name of the medical device, according to the marketing authorisation certificate;
  8. b) number and date of the marketing authorisation certificate;
  9. c) number of the registration certificate issued in the Single Register of Medical Devices registered in the Eurasian Economic Union (if applicable);
  10. d) implementation version, type or model of the medical device, as per the registration certificate;
  11. e) potential risk of usage class;
  12. f) type code and name of the medical device in accordance with the Nomenclature Classification of Medical Devices, as approved by Order of the Ministry of Healthcare of the RF dated 6 June 2012, no. 4n (registered by the Ministry of Justice of the RF on 9 July, 2012, reg. no. 24852)1.

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1 As amended by orders of the Ministry of Healthcare of the Russian Federation dated 25 September 2014, no. 557n (registered by the Ministry of Justice of the RF on 17 December 2014, reg, no. 35201) and dated 7 July 2020, no. 686n (registered by the Ministry of Justice of the RF on 10 August 2020, reg. no. 59225).

  1. g) type code and name of the medical device in accordance with the Nomenclature of Medical Devices, as per the rules approved by a Decision of the Eurasian Economic Committee dated 29 December 2015, no. 1772 (if applicable);
  2. h) reference number in the catalogue of goods, services and work intended to ensure state and municipal needs, as per the Rules for the creation and maintenance of such catalogues of goods, services and work intended to ensure state and municipal needs in the Single State Purchase system, and the Rules for the use of such catalogues, as approved by Decree of the Government of the RF dated 8 February, 2017, no. 1453.
  3. i) name of the manufacturer of the medical device, according to the marketing authorisation certificate;
  4. j) name of the country of origin of the medical device, according to the marketing authorisation certificate;
  5. k) manufacturing address (addresses) of the medical device, according to the marketing authorisation certificate;
  6. l) composition and scope of supply of the medical device (if applicable) and the list of accessories (if applicable), according to the marketing authorisation certificate;
  7. m) batch (lot) number, serial number (if applicable);
  8. n) number of medical devices in circulation (stating the serial number, lot numbers and batch numbers, factory numbers etc.), associated with the adverse event, itemised;
  9. o) date of manufacture (production) of the medical device;
  10. p) expiry date or service life term of the medical device;
  11. q) expiry date of the warranty period, service life, operational period, as set by the manufacturer (if applicable/if provided);
  12. r) full and abbreviated (if applicable) name, including the company name, legal form of the legal entity responsible for distribution and sales of the relevant batch (lot, factory number) of the medical device, its address, or, in the event of an individual entrepreneur, his/her full name (with patronymic, if applicable), home address and ID data (hereinafter the Vendor), as well as the tax identification number, main state registration number in the State Register of Legal Entities, or the state registration number for the individual entrepreneur, his/her phone number and email (if applicable);
  13. s) information regarding the registration number of the Vendor as per the Notification Register of the entities providing circulation of the medical devices (hereinafter the Notification Register)4.
  14. t) name and address of the premises used as storage for the aforementioned batch (lot, factory number, model, variant etc.) of the medical device, as per the Notification Register (if applicable);
  15. u) full and abbreviated (if applicable) name, including the company name, legal form of the legal entity responsible for the application of the relevant batch (lot, factory number) of the medical device in question, its address (stating exact addresses involved in the application of this device), or, in the event of an individual entrepreneur, his/her full name (with patronymic name, if applicable), home address and ID data, as well as tax identification number, main state registration number in the State Register of Legal Entities, or state registration number for the individual entrepreneur, his/her phone number and email

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2 Official site of the Eurasian Economic Union http://www.eaeunion.org/, 31 December 2015.

3 Collection of Legislative Acts of the Russian Federation, 2017, no. 7, art. 1084; no. 28, art. 4421.

4 Paragraph 12 of the Rules for the submission of Notifications regarding the initiation of certain types of businesses, and taking account of such Notifications, as approved by a Decree of the Government of the Russian Federation dated 16 July 2009, no. 584 (Collection of Legislative Acts of the Russian Federation, 2019, no. 30, art. 3823).

of the said legal entity or individual entrepreneur (if applicable)

  1. v) country or name of the administrative region of the RF (if the event occurred in the RF), residential area (city, town etc.) and address of the adverse event occurrence;
  2. w) location of the relevant medical device at the moment of submission of the Notification (recycled, quarantined, transferred to the vendor or manufacturer (or its authorised representative), still in use, other);
  3. x) information obtained from acts, reports, maintenance and other service logs etc. (if applicable);
  4. y) number of medical devices involved in the adverse event (if known).
  5. Event description:
  6. a) date on which the Notification was sent to the Federal Service for Overseeing Healthcare;
  7. b) type of notification on the adverse event occurring during the use of the medical device (initial, follow-up, final);
  8. c) type of Report on the Adverse Event occurring during the use of the medical device (initial, follow-up, final)
  9. d) date on which the adverse event had become known to the notifying party;
  10. e) date on which the adverse event occurred;
  11. f) for the implanted medical devices:

Date of implantation

Date of explantation

Length of implantation (when the exact date of implantation or the start date of the operation is known);

Data obtained from the sub-system for conducting specialised registers of patients under separate ICD diseases and citizen categories, from monitoring by an organization for providing high-tech medical aid and health resort treatment, the Single State Information System in Healthcare5, or from other information systems intended for the collection, storage, processing and provision of information concerning the activity of medical organizations and the services they provide , as well as from the federal state information system “The Single Automated Vertically Integrated Information and-Analytical System for the Provision of Socio-Medical Assessment” (if the entity providing circulation of the medical devices has access to any of those systems);

  1. g) date of the Report on the Adverse Event occurring during the use of the medical device;
  2. h) registration number of the adverse event, as assigned by the manufacturer (if any);
  3. i) The type and variant of the adverse event mentioned in the Report on the Adverse Event shall be structured according to the variants of the adverse events, adverse reactions associated with the use of medical devices, facts and circumstances posing a threat to human life or health associated with the circulation of registered medical devices;
  4. j) description of side effects not specified in the medical device’s instructions for use or operating manual, adverse reactions during its use, the possibilities of medical device interaction, the facts and circumstances that may create a danger to the life and health of individuals and medical workers when using and operating medical devices;
  5. k) user of the medical device involved (physician, nurse, patient, other);
  6. l) usage of the medical device (initial, repeated use of a single use medical device, multi-use medical device usage, medical device after maintenance,

______________________________

5 Sub-clause ‘f’ of paragraph 4 of the Statute on the Single State Information System in the Sphere of Healthcare, as approved by Decree of the Government of the Russian Federation dated 5 May 2018 no. 555 “Single State Information System in the Sphere of Healthcare” (Collection of Legislative Acts of the Russian Federation, 2018, no. 20, art. 2849).

or service; the issue was identified before the start of usage, other);

  1. m) category of the adverse event associated with the use of the medical device involved:

Serious and/or unexpected side reaction, not stated in the instructions for use or in the operating manual for the related medical device;

Side effect associated with the use of the medical device;

Specific interaction of several medical devices;

Substandard quality of the medical device;

Any circumstances posing a hazard to the life and well-being of the general public and health care professionals, associated with the use and/or operation of the medical device;

Any other adverse event issues;

  1. n) measures taken by the user or by the medical organization in order to rectify the adverse event;
  2. Information regarding the affected person:
  3. a) affected person (home stay patient, daycare hospital patient, fully hospitalised patient, medical staff, visitor, technical staff, self-care, other);
  4. b) full name (including patronymic, if applicable);
  5. c) gender, age, weight, height (if applicable);
  6. d) severity criteria (harm incurred);
  7. e) outcome;
  8. f) description of the related issue;
  9. g) number of affected persons (if applicable);
  10. h) actions taken and care provided to the affected person by the medical organization.
  11. Additional information:
  12. a) preliminary conclusion and analysis made by the manufacturer (or its authorised representative) (necessary for the initial or follow up report);
  13. b) initial corrective actions performed by the manufacturer;
  14. c) proposed date of the next report;
  15. d) results of the final analysis performed by the manufacturer (for the final report);
  16. e) corrective actions related to the safety of the medical device;
  17. f) schedule for the corrective actions related to the safety of the medical device;
  18. g) the number of adverse events involving the same type of medical device and the same root cause, related to the devices of the same version of the event as per the Designation System of Adverse Events (to the best knowledge of the manufacturer or its authorised representative);

Appendix no. 3 to the Procedure

for reporting by the entities providing circulation of the medical devices of any

adverse events not mentioned

in the instructions for use

or operating manual for the related medical device,

adverse reactions during its usage,

specific issues related to the medical device

interactions, and any other related findings

which potentially may pose a threat

to the life and health of patients and healthcare

personnel using or operating medical devices, as approved by the Order

of the Ministry of Healthcare of the RF

  1. 1113n dated 19 October 2020

Report on Corrective Actions

related to the safety of the medical device

  1. Information regarding entities providing the circulation of medical devices:
  2. a) full and (if applicable) short name, including business name, legal form of the legal entity, address of the location or surname, name and patronymic (if applicable), details of the identification document, address of the place of residence of the individual entrepreneur, as well as the phone numbers and e-mail address of the legal entity or individual entrepreneur (if applicable);
  3. b) tax payer identification number;
  4. c) registration number according to the State Register of Legal Entities or Private Entrepreneur registration number;
  5. d) type of organization (organization created on the territory of the RF, or representative office of the foreign company accredited on the territory of the RF, or individual entrepreneurs registered on the territory of the RF).
  6. Information about the medical device associated with the adverse event:
  7. a) name of the medical device, according to the marketing authorisation certificate;
  8. b) number and date of the marketing authorisation certificate;
  9. c) number of the registration certificate issued in the Single Register of Medical Devices registered in the Eurasian Economic Union (if applicable);
  10. d) implementation version, type or model of the medical device, as per the registration certificate;
  11. e) potential risk of usage class;
  12. f) type code and name of the medical device in accordance with the Nomenclature Classification of Medical Devices, as approved by Order of the Ministry of Healthcare of the RF dated 6 June 2012, no. 4n (registered by the Ministry of Justice of the RF on 9 July, 2012, reg. no. 24852)1.
  13. g) type code and name of the medical device in accordance with the Nomenclature of Medical Devices, as per the rules approved by the Decision

______________________________

1 As amended by orders of the Ministry of Healthcare of the Russian Federation dated 25 September 2014, no. 557n (registered by the Ministry of Justice of the RF on 17 December 2014, reg, no. 35201) and dated 7 July 2020, no. 686n (registered by the Ministry of Justice of the RF on 10 August 2020, reg. no. 59225).

of the Eurasian Economic Committee on 29 December, 2015, no. 1772 (if applicable);

  1. h) reference number in the catalogue of goods, services and work intended to ensure state and municipal needs, as per the Rules for the creation and maintenance of such catalogues of goods, services and work intended to ensure state and municipal needs in the Single State Purchase system, and the Rules for the use of such catalogues, as approved by Decree of the Government of the RF dated 8 February, 2017, no. 1453.
  2. i) name of the manufacturer of the medical device, according to the marketing authorisation certificate;
  3. j) name of the country of origin of the medical device, according to the marketing authorisation certificate;
  4. k) manufacturing address (addresses) of the medical device, according to the marketing authorisation certificate;
  5. l) composition and scope of supply of the medical device (if applicable) and the list of accessories (if applicable), according to the marketing authorisation certificate;
  6. m) batch (lot) number, serial number (if applicable);
  7. n) number of medical devices in circulation (stating the serial number, lot numbers and batch numbers, factory numbers etc.), associated with the adverse event, itemised;
  8. o) date of manufacture (production) of the medical device;
  9. p) expiry date or service life term of the medical device;
  10. q) expiry date of the warranty period, service life, operational period, as set by the manufacturer (if applicable/if provided);
  11. r) full and abbreviated (if applicable) name, including the company name, legal form of the legal entity responsible for distribution and sales of the relevant batch (lot, factory number) of the medical device, its address, or, in the event of an individual entrepreneur, his/her full name (with patronymic, if applicable), home address and ID data (hereinafter the Vendor), as well as the tax identification number, main state registration number in the State Register of Legal Entities, or the state registration number for the individual entrepreneur, his/her phone number and email (if applicable);
  12. s) information regarding the registration number of the Vendor as per the Notification Register of the entities providing circulation of the medical devices (hereinafter the Notification Register)4.
  13. t) name and address of the premises used as storage for the aforementioned batch (lot, factory number, model, variant etc.) of the medical device, as per the Notification Register (if applicable);
  14. u) full and abbreviated (if applicable) name, including the company name, legal form of the legal entity responsible for distribution and sales of the relevant batch (lot, factory number) of the medical device, its address, or, in the event of an individual entrepreneur, his/her full name (with patronymic, if applicable), home address and ID data, as well as the tax identification number, main state registration number in the State Register of Legal Entities, or the state registration number for the individual entrepreneur, his/her phone number and email (if applicable);

____________________________

2 Official site of the Eurasian Economic Union http://www.eaeunion.org/, 31 December 2015.

3 Collection of Legislative Acts of the Russian Federation, 2017, no. 7, art. 1084; no. 28, art. 4421.

4 Paragraph 12 of the Rules for the submission of Notifications regarding the initiation of certain types of businesses, and taking account of such Notifications, as approved by a Decree of the Government of the Russian Federation dated 16 July 2009, no. 584 (Collection of Legislative Acts of the Russian Federation, 2019, no. 30, art. 3823).

  1. v) country or name of the administrative region of the RF (if the event occurred in the RF), residential area (city, town etc.) and address of the adverse event occurrence;
  2. w) location of the relevant medical device at the moment of submission of the Notification (recycled, quarantined, transferred to the vendor or manufacturer (or its authorised representative), still in use, other);
  3. x) information obtained from acts, reports, maintenance and other service logs etc. (if applicable);
  4. y) number of medical devices involved in the adverse event (if known).
  5. Event description:
  6. a) Date on which the Notification was sent to the Federal Service for Overseeing Healthcare;
  7. b) type of notification on the adverse event occurring during the use of the medical device (initial, follow-up, final);
  8. c) type of Report on the Adverse Event occurring during the use of the medical device (initial, follow-up, final)
  9. d) date on which the adverse event had become known to the notifying party;
  10. e) date on which the adverse event occurred;
  11. f) for the implanted medical devices:

Date of implantation

Date of explantation

Length of implantation (when the exact date of implantation or the start date of the operation is known);

Data obtained from the sub-system for conducting specialised registers of patients under separate ICD diseases and citizen categories, from monitoring by an organization for providing high-tech medical aid and health resort treatment, the Single State Information System in Healthcare5, or from other information systems intended for the collection, storage, processing and provision of information concerning the activity of medical organizations and the services they provide , as well as from the federal state information system “The Single Automated Vertically Integrated Information and-Analytical System for the Provision of Socio-Medical Assessment” (if the entity providing circulation of the medical devices has access to any of those systems);

  1. g) date of the Report on the Adverse Event occurring during the use of the medical device;
  2. h) registration number of the adverse event, as assigned by the manufacturer (if any);
  3. i) The type and variant of the adverse event mentioned in the Report on the Adverse Event shall be structured according to the variants of the adverse events, adverse reactions associated with the use of medical devices, facts and circumstances posing a threat to human life or health associated with the circulation of registered medical devices;
  4. j) description of side effects not specified in the medical device’s instructions for use or operating manual, adverse reactions during its use, the possibilities of medical device interaction, the facts and circumstances that may create a danger to the life and health of individuals and medical workers when using and operating medical devices;
  5. k) user of the medical device involved (physician, nurse, patient, other);
  6. l) usage of the medical device (initial, repeated use of a single use medical device, multi-use medical device usage, medical device after maintenance or service; the issue was identified before the start of usage, other);

______________________________

5 Sub-clause ‘f’ of paragraph 4 of the Statute on the Single State Information System in the Sphere of Healthcare, as approved by Decree of the Government of the Russian Federation dated 5 May 2018 no. 555 “Single State Information System in the Sphere of Healthcare” (Collection of Legislative Acts of the Russian Federation, 2018, no. 20, art. 2849).

  1. m) category of the adverse event associated with the use of the medical device involved:

Serious and/or unexpected side reaction, not stated in the instructions for use or in the operating manual for the related medical device;

Side effect associated with the use of the medical device;

Specific interaction of several medical devices;

Substandard quality of the medical device;

Any circumstances posing a hazard to the life and well-being of the general public and health care professionals, associated with the use and/or operation of the medical device;

Any other adverse event issues;

  1. n) measures taken by the user or by the medical organization in order to rectify the adverse event;
  2. Information regarding the affected person:
  3. a) affected person (home stay patient, day care hospital patient, fully hospitalised patient, medical staff, visitor, technical staff, self-care, other);
  4. b) full name (including patronymic, if applicable);
  5. c) gender, age, weight, height (if applicable);
  6. d) severity criteria (harm incurred);
  7. e) outcome;
  8. f) description of the related issue;
  9. g) code and term assigned to the affected person’s issue related to the adverse event which shall be indicated in accordance with the variant assigned to this AE in the Designation System of Adverse Events;
  10. h) number of affected persons (if applicable);
  11. i) actions taken and care provided to the affected person by the medical organization.
  12. Additional information:
  13. a) preliminary conclusion and analysis made by the manufacturer (or its authorised representative) (necessary for the initial or follow up report);
  14. b) initial corrective actions performed by the manufacturer;
  15. c) proposed date of the next report;
  16. d) results of the final analysis performed by the manufacturer (for the final report);
  17. e) type and variant of the adverse event as per the Designation System of Adverse Events;
  18. f) corrective actions related to the safety of the medical device;
  19. g) schedule for the corrective actions related to the safety of the medical device;
  20. h) the number of adverse events involving the same type of medical device and the same root cause, related to devices of the same version of the event as per the Designation System of Adverse Events (to the best knowledge of the manufacturer or its authorised representative);
  21. i) general information and the reason for corrective actions (this is necessary for the Report on Corrective Actions);
  22. j) description and justification of corrective actions (this is necessary for the Report on Corrective Actions);
  23. k) recommendations for users (this is necessary for the Report on Corrective Actions);
  24. l) list and schedule of corrective actions (this is necessary for the Report on Corrective Actions).

Appendix no. 4 to the Procedure

for reporting by the entities providing circulation of the medical devices of any

adverse events not mentioned

in the instructions for use

or operating manual for the related medical device,

adverse reactions during its usage,

specific issues related to the medical device

interactions, and any other related findings

which potentially may pose a threat

to the life and health of patients and healthcare

personnel using or operating medical devices, as approved by the Order

of the Ministry of Healthcare of the RF

  1. 1113n dated 19 October 2020

Recommended template

Safety Notice for Medical Devices

  

  1. Information regarding entities providing the circulation of medical devices:
  2. a) full and (if applicable) short name, including business name, legal form of the legal entity, address of the location or surname, name and patronymic (if applicable), details of the identification document, address of the place of residence of the individual entrepreneur, as well as the phone numbers and e-mail address of the legal entity or individual entrepreneur (if applicable);
  3. b) tax payer identification number;
  4. c) registration number according to the State Register of Legal Entities or Private Entrepreneur registration number;
  5. d) type of organization (organization created on the territory of the RF, or representative office of the foreign company accredited on the territory of the RF, or individual entrepreneurs registered on the territory of the RF).
  6. Information about the medical device associated with the adverse event:
  7. a) name of the medical device, according to the marketing authorisation certificate;
  8. b) number and date of the marketing authorisation certificate;
  9. c) number of the registration certificate issued in the Single Register of Medical Devices registered in the Eurasian Economic Union (if applicable);
  10. d) implementation version, type or model of the medical device, as per the registration certificate;
  11. e) potential risk of usage class;
  12. f) type code and name of the medical device in accordance with the Nomenclature Classification of Medical Devices, as approved by Order of the Ministry of Healthcare of the RF dated 6 June 2012, no. 4n (registered by the Ministry of Justice of the RF on 9 July, 2012, reg. no. 24852)1.
  13. g) type code and name of the medical device in accordance with the Nomenclature of Medical Devices, as per the rules approved by the Decision

______________________________

1 As amended by orders of the Ministry of Healthcare of the Russian Federation dated 25 September 2014, no. 557n (registered by the Ministry of Justice of the RF on 17 December 2014, reg, no. 35201) and dated 7 July 2020, no. 686n (registered by the Ministry of Justice of the RF on 10 August 2020, reg. no. 59225).

of the Eurasian Economic Committee on 29 December, 2015, no. 1772 (if applicable);

  1. h) reference number in the catalogue of goods, services and work intended to ensure state and municipal needs, as per the Rules for the creation and maintenance of such catalogues of goods, services and work intended to ensure state and municipal needs in the Single State Purchase system, and the Rules for the use of such catalogues, as approved by Decree of the Government of the RF dated 8 February, 2017, no. 1453.
  2. i) name of the manufacturer of the medical device, according to the marketing authorisation certificate;
  3. j) name of the country of origin of the medical device, according to the marketing authorisation certificate;
  4. k) manufacturing address (addresses) of the medical device, according to the marketing authorisation certificate;
  5. l) composition and scope of supply of the medical device (if applicable) and the list of accessories (if applicable) according to the marketing authorisation certificate;
  6. m) batch (lot) number, serial number (if applicable);
  7. n) number of medical devices in circulation (stating the serial number, lot numbers and batch numbers, factory numbers etc.), associated with the adverse event, itemised;
  8. o) date of manufacture (production) of the medical device;
  9. p) expiry date or service life term of the medical device;
  10. q) expiry date of the warranty period, service life, operational period, as set by the manufacturer (if applicable/if provided);
  11. r) number of medical devices involved in the adverse event (if known).
  12. Additional information:

а) type of corrective action (i.e., suspension of usage of the medical device, exchange of affected medical devices for new ones performed by the manufacturer (or its authorised representative), return of the relevant medical device to the manufacturer (or its authorised representative); destruction of the relevant medical device, change of properties and/or features affecting the safety, quality and efficiency of the related medical device; improvement of the properties and features of the medical device while preserving its functionality and (or) principle of operation, including amending the Instructions for use or operating manual, software updates, other) (this is necessary for the Safety Notice);

  1. b) description of the issue (this is necessary for the Safety Notice);
  2. c) description of actions to be taken by the medical device user (this is necessary for the Safety Notice);
  3. d) indication stating the need to distribute the notice to persons who shall be notified about the issue and/or shall perform the corrective measures (this is necessary for the Safety Notice);
  4. e) indication stating the need to provide information regarding medical devices distributed to other organizations to the manufacturer or its authorised representative, and notification to those organizations regarding the adverse event (this is necessary for the Safety Notice);
  5. f) contact details for the specific Safety Notice (name of the organization, address, phone number, email address).

____________________________

2 Official site of the Eurasian Economic Union http://www.eaeunion.org/, 31 December 2015.

3 Collection of Legislative Acts of the Russian Federation, 2017, no. 7, art. 1084; no. 28, art. 4421.

Appendix no. 5 to the Procedure

for reporting by the entities providing circulation of the medical devices of any

adverse events not mentioned

in the instructions for use

or operating manual for the related medical device,

adverse reactions during its usage,

specific issues related to the medical device

interactions, and any other related findings

which potentially may pose a threat

to the life and health of patients and healthcare

personnel using or operating medical devices, as approved by the Order

of the Ministry of Healthcare of the RF

  1. 1113n dated 19 October 2020

Recommended template

Report on the Clinical Monitoring of the medical device

  1. Information regarding entities providing the circulation of medical devices:
  2. a) full and (if applicable) short name, including business name, legal form of the legal entity, address of the location or surname, name and patronymic (if applicable), details of the identification document, address of the place of residence of the individual entrepreneur, as well as the phone numbers and e-mail address of the legal entity or individual entrepreneur (if applicable);
  3. b) tax payer identification number;
  4. c) registration number according to the State Register of Legal Entities or Private Entrepreneur registration number;
  5. d) type of organization (organization created on the territory of the RF, or representative office of the foreign company accredited on the territory of the RF, or individual entrepreneurs registered on the territory of the RF).
  6. Information about the medical device associated with the adverse event:
  7. a) name of the medical device, according to the marketing authorisation certificate;
  8. b) number and date of the marketing authorisation certificate;
  9. c) number of the registration certificate issued in the Single Register of Medical Devices registered in the Eurasian Economic Union (if applicable);
  10. d) implementation version, type or model of the medical device, as per the registration certificate;
  11. e) potential risk of usage class;
  12. f) type code and name of the medical device in accordance with the Nomenclature Classification of Medical Devices, as approved by Order of the Ministry of Healthcare of the RF dated 6 June 2012, no. 4n (registered by the Ministry of Justice of the RF on 9 July, 2012, reg. no. 24852)1.
  13. g) type code and name of the medical device in accordance with the Nomenclature of Medical Devices, as per the rules approved by a Decision of the Eurasian Economic Committee dated 29 December 2015, no. 1772 (if applicable);

______________________________

1 As amended by orders of the Ministry of Healthcare of the Russian Federation dated 25 September 2014, no. 557n (registered by the Ministry of Justice of the RF on 17 December 2014, reg, no. 35201) and dated 7 July 2020, no. 686n (registered by the Ministry of Justice of the RF on 10 August 2020, reg. no. 59225).

2 Official site of the Eurasian Economic Union http://www.eaeunion.org/, 31 December 2015.

  1. h) reference number in the catalogue of goods, services and work intended to ensure state and municipal needs, as per the Rules for the creation and maintenance of such catalogues of goods, services and work intended to ensure state and municipal needs in the Single State Purchase system, and the Rules for the use of such catalogues, as approved by Decree of the Government of the RF dated 8 February, 2017, no. 1453.
  2. i) name of the manufacturer of the medical device, according to the marketing authorisation certificate;
  3. j) name of the country of origin of the medical device, according to the marketing authorisation certificate;
  4. k) manufacturing address (addresses) of the medical device, according to the marketing authorisation certificate;
  5. l) composition and scope of supply of the medical device (if applicable) and the list of accessories (if applicable) according to the marketing authorisation certificate;
  6. m) batch (lot) number, serial number (if applicable);
  7. n) number of medical devices in circulation (stating the serial number, lot numbers and batch numbers, factory numbers etc.), associated with the adverse event, itemised;
  8. o) date of manufacture (production) of the medical device;
  9. p) expiry date or service life term of the medical device;
  10. q) expiry date of the warranty period, service life, operational period, as set by the manufacturer (if applicable/if provided);
  11. r) full and abbreviated (if applicable) name, including the company name, legal form of the legal entity responsible for distribution and sales of the relevant batch (lot, factory number) of the medical device, its address, or, in the event of an individual entrepreneur, his/her full name (with patronymic, if applicable), home address and ID data (hereinafter the Vendor), as well as the tax identification number, main state registration number in the State Register of Legal Entities, or the state registration number for the individual entrepreneur, his/her phone number and email (if applicable);
  12. s) information regarding the registration number of the Vendor as per the Notification Register of the entities providing circulation of the medical devices (hereinafter the Notification Register)4.
  13. t) name and address of the premises used as storage for the aforementioned batch (lot, factory number, model, variant etc.) of the medical device, as per the Notification Register (if applicable);
  14. u) full and abbreviated (if applicable) name, including the company name, legal form of the legal entity responsible for distribution and sales of the relevant batch (lot, factory number) of the medical device, its address, or, in the event of an individual entrepreneur, his/her full name (with patronymic, if applicable), home address and ID data, as well as the tax identification number, main state registration number in the State Register of Legal Entities, or the state registration number for an individual entrepreneur, his/her phone numbers and email (if applicable);
  15. Event description:
  16. a) Date on which the Adverse Event Notification was sent to the Federal Service for Overseeing

____________________________

2 Official site of the Eurasian Economic Union http://www.eaeunion.org/, 31 December 2015.

3 Collection of Legislative Acts of the Russian Federation, 2017, no. 7, art. 1084; no. 28, art. 4421.

4 Paragraph 12 of the Rules for the submission of Notifications regarding the initiation of certain types of businesses, and taking account of such Notifications, as approved by a Decree of the Government of the Russian Federation dated 16 July 2009, no. 584 (Collection of Legislative Acts of the Russian Federation, 2019, no. 30, art. 3823).

Healthcare;

  1. b) type of notification on the adverse event occurring during the use of the medical device (initial, follow-up, final);
  2. c) type of Report on the Adverse Event occurring during the use of the medical device (initial, follow-up, final)
  3. d) for the implanted medical devices:

Date of implantation

Date of explantation

Length of implantation (when the exact date

of implantation or the start date of the operation is known);

Data obtained from the sub-system for conducting specialised registers of patients under separate ICD diseases and citizen categories, from monitoring by an organization for providing high-tech medical aid and health resort treatment, or from other information systems intended for the collection, storage, processing and provision of information concerning the activity of medical organizations and the services they provide, as well as from the federal state information system “The Single Automated Vertically Integrated Information and Analytical System for the Provision of Socio-Medical Assessment” (if the entity providing the circulation of the medical devices has access to any of those systems);

  1. e) date of the Report on the Adverse Event occurring during the use of the medical device.
  2. Additional information:
  3. a) list of identified residual risks related to the medical device;
  4. b) goals and objectives of the clinical monitoring of the safety and efficiency of the medical device;
  5. c) work flow of the clinical monitoring of the safety and efficiency of the medical device;
  6. d) clinical data obtained in the reporting period;
  7. e) evaluation of the clinical data obtained in the reporting period;
  8. f) overall evaluation of the clinical data obtained during the whole period of the clinical monitoring of the safety and efficiency of the medical device;
  9. g) conclusion of the need (or no need) to correct the plan of clinical monitoring of the safety and efficiency of the medical device;
  10. h) conclusion of the need (or no need) to implement any corrective actions related to the safety of the medical device;
  11. i) description of corrective actions related to the safety of the medical device (if any);
  12. j) conclusion (justification) on the safety and efficiency of the medical device;
  13. k) suggestion on the need (or no need) to extend the cycle of clinical monitoring of the safety and efficiency of the medical device;
  14. l) any additional comments (if applicable).