On the procedure for the safety monitoring of medical devices for manufacturers

Attention of the entities executing
circulation of medical devices

Ministry of Healthcare of the Russian
Federation

FEDERAL SERVICE FOR SURVEILLANCE IN HEALTHCARE
(ROSZDRAVNADZOR)

Slavyanskaya Sq. 4, build. 1, Moscow, 109074

phone: (495) 698 45 38; 698 46 11

28, 12, 2012 № 04И-1311 /12

Ref. No.________ dated_____________                            

 

On the procedure for the safety
monitoring of medical devices
for manufacturers

According to Federal Law No. 323-FZ dated 21 November, 2012 “On the fundamentals of public healthcare in the Russian Federation”, any and all medical devices circulating within the territory of the Russian Federation, shall be subject to safety monitoring in order to identify and prevent any adverse events not mentioned in the instructions for use or operator’s guide 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.

By Order of the Government of the Russian Federation No. 323 dated 30 June, 2004 (amended as per Order of the Government of Russian Federation No. 614 dated 19 June, 2012) “On the approval of the Statement on the Federal Service for Surveillance in Healthcare”, state functions related to the safety monitoring of medical devices are assigned to the Federal Service for Surveillance in Healthcare (Roszdravnadzor).

As part of the related monitoring tasks, Roszdravnadzor collects, processes and reviews information about the safety of medical devices at every stage of their circulation process, including clinical trials and the postmarketing period.

In order to explain how the entities executing circulation of medical devices shall participate in the safety monitoring of medical devices, Roszdravnadzor together with its subdivision FGBU VNIIIMT of Roszdravnadzor has developed a document called “Procedure for the safety monitoring of medical devices for manufacturers (marketing authorization holders)”.

This Procedure for the safety monitoring of medical devices for manufacturers (marketing authorization holders) provides a consistent approach to the collection, processing and provision of the information related to the safety of medical devices to Roszdravnadzor, and contains an explanation of certain practical issues related to compliance with the requirements set forth in the Russian Federation’s legislation in the field of safety monitoring of medical devices for manufacturers.

At the same time Roszdravnadzor would like to emphasize that the Procedure for the safety monitoring of medical devices for manufacturers/marketing authorization holders has no obligatory nature but only recommends a certain course of actions, therefore any deviations from the procedure, if they do not violate the Legislation of the Russian Federation, will not result in any administrative or other liability.

 

Appendix: 1 copy, 22 pages.

Deputy Head of the Agency                            (signature)                                   E. A. Telnova

 

APPROVED

Deputy Head of the
Federal Service for
Surveillance in Healthcare

/Signature/ Е.А.Telnova

“28” December 2012.

Procedure for the safety monitoring of medical devices for manufacturers/marketing authorization holders

Contents

NOTICE

This Procedure for the safety monitoring of medical devices for manufacturers/marketing authorization holders is not a regulatory legal act.

This document is based on the general approaches of the Federal Service for Surveillance in Healthcare in relation to the issue in question, and it contains explanations of several practical issues related to compliance with the requirements of the legislation of the Russian Federation in the field of safety monitoring of medical devices.

Any deviation from the course of actions described in the procedure for the safety monitoring of medical devices for manufacturers (provided there is no violation of related legislation of the Russian Federation) will not result in any administrative liability or liability of any other kind.

This document was developed with the participation of the following employees of the Roszdravnadzor: Dr. E. A. Telnova, Professor, V.V. Kosenko, phD, S.V. Glagoleva; also E.V. Borisova, S.V. Novikov and O.V. Romanov from the FGBU VNIIIMT of Roszdravnadzor participated in the working group.

1.Introduction

Reporting of adverse events and their subsequent evaluation aims for the improvement of public healthcare and the safety of patients, users and other individuals by means of sharing information capable of decreasing the probability of re-occurrence of the adverse event or mitigating the consequences of such re-occurrence.

In accordance with Article 95 of Federal Law No. 323-FZ dated 21 November, 2011 “On the fundamentals of public healthcare in the Russian Federation” (hereinafter Federal Law No. 323-FZ), the State must control the circulation of medical devices.

State control of the circulation of medical devices includes control of the technical tests, toxicological tests, clinical trials, efficiency, safety, manufacturing, production, sales, storage, transportation, import to the Russian Federation or export of medical devices from the Russian Federation, as well as control over their assembly, commissioning, usage, operation, including maintenance and repairs, application, disposal or destruction [1].

Safety monitoring of medical devices is one of the elements of the State control of the circulation of medical devices [1].

According to Article 96 of Federal Law No. 323-FZ, any and all medical devices circulating within the territory of the Russian Federation shall be subject to safety monitoring in order to identify and prevent any adverse events not mentioned in the instructions for use or operator’s guide 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.

The entities executing circulation of the medical devices shall report any adverse events not mentioned in the instructions for use or operator’s guide 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].

In the event of a failure to report or an attempt to hide such cases and information, the entities to which the aforementioned cases and/or information became known in the course of their professional engagement shall be liable as per the applicable legislation of the Russian Federation.

Order of the Government of the Russian Federation No. 970 dated 25 September, 2012 “Statement on the State control of the circulation of medical devices” sets out the procedure for the execution of control measures and actions of the State control authority when the health and life of individuals and healthcare practitioners are immediately endangered or there is a threat of danger because of the usage of medical devices [2].

Order of the Ministry of Healthcare of the Russian Federation No. 12n dated 20 June, 2012, “On approval of the Procedure for the reporting of any adverse events not mentioned in the instructions for use or operator’s guide 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 by the entities executing circulation of medical devices” sets out the rules for reporting the aforementioned cases obligatory to all entities executing the circulation of medical devices [3].

Article 14 of Federal Law no. 323 FZ defines the powers of the federal government authorities in the field of healthcare, among which are the safety monitoring of medical devices, registration of side effects and adverse effects occuring in the course of the usage of medical devices, as well as the facts and circumstances which can possibly pose a threat to the life and health of individuals in the course of circulation of the registered medical devices.

In accordance with the Article 96, part 5 of the Federal Law no. 323 FZ, the procedure for the safety monitoring of medical devices has to be established by the approved federal government authority.

By Order of the Government of the Russian Federation No. 323 dated 30 June, 2004 (amended as Order of the Government of the Russian Federation No. 614 dated 19 June, 2012) “On approval of the Statute on the Federal Service for Surveillance in Healthcare”, par. 5.1.2.3, the safety monitoring of medical devices is assigned to the Federal Service for Surveillance in Healthcare (Roszdravnadzor) [4].

As per part 6 of the Article 96 of Federal Law no. 323 FZ, based on the results of the safety monitoring of medical devices, when information regarding any adverse events not mentioned in the instructions for use or operator’s guide 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 registered and approved medical devices, the Government authority of the Russian Federation at the federal level must review the issue and decide on the possible suspension of the usage of the medical device concerned or on taking such device out of circulation [1].

Information about related decisions of Roszdravnadzor on the results of safety monitoring shall be posted on the official web site of the Federal Service on Surveillance in Healthcare on the Internet (see Article 96, part 8 of Federal Law No. 323-FZ).

2.Scope

Actual recommendations are developed on the basis of Article 96, part 5 of Federal Law No. 323-FZ dated 21 November, 2011 “On the fundamentals of public healthcare in the Russian Federation”, par. 5.1.2.3 of the Statute on the Federal Service on Surveillance in Healthcare approved by Order of the Government of the Russian Federation No. 323 dated 30 June, 2004 (amended as Order of the Government of the Russian Federation No. 614 dated 19 June, 2012) and are intended for the manufacturers of medical devices or their authorized representatives in order to help them comply with the requirements of the federal legislation on the execution of the monitoring of the safety of medical devices.

3.Terms and definitions

For the purposes of this document, the following terms and definitions are used:

Medical devices (MD) are any instruments, apparatuses, devices, equipment, materials and other items used for medical purposes individually or in conjunction, or together with other accessories necessary for operation of the said items as per indications; this includes also specific software products; medical devices are generally items intended by the manufacturer for the prophylaxis, diagnostics, treatment and medical rehabilitation of medical conditions, diseases and disorders, for monitoring of human body parameters, for medical investigations, recovery, substitution, change of the anatomical structures or physiological functions of the human body, for prevention or interruption of pregnancy, and their functionality is executed by means of the pharmacological, immunological, genetic or metabolic effect on the human body. Medical devices can be exchangeable if they are similar in terms of functionality, quality and technical parameters and could replace each other. (As per Federal Law № 323-FZ [1]).

The manufacturer (producer) of medical device means the legal entity or individual entrepreneur responsible for the quality, efficiency and safety of the medical devices at each step of its life cycle regardless of whether the device is released for circulation by the aforementioned entity itself or by any other third party on its behalf. (Developed while considering documents ref. nos. [7], [8], [11], [12]).

The authorized representative of the manufacturer means the legal entity or individual entrepreneur registered on the territory of the Russian Federation and authorized by the manufacturer of the medical product to represent its interests with respect to issues related to the circulation of the relevant medical product on the territory of the Russian Federation, including issues related to the procedures for the assessment of conformity and state registration that may act as holder of the relevant marketing authorization for the relevant medical product. (Developed on the basis of GHTF/SGI/N055:2009 [12]).

The safety officer for medical devices is an officer entitled to communicate with the entities executing circulation of the medical devices regarding any adverse events related to the usage of the medical devices. (Developed while considering document ref. no. [3]).

Entities executing circulation of medical devices means organizations duly created in the Russian Federation, or offices of foreign organizations duly authorized in the Russian Federation, or individual entrepreneurs registered in the Russian Federation, or individuals otherwise performing technical and toxicological tests, clinical studies, expert review of the quality, efficiency and safety of medical devices, executing their marketing authorization, manufacturing, processing, import to the Russian Federation and export from the Russian Federation, conformity certification, state control, storage, transportation, sales, assembling, commissioning, application, operation (including maintenance) as per the related regulatory, technical or operational documentation issued by the manufacturer, and also executing repairs, disposal or final destruction of the aforementioned medical devices. (As per Order of the Ministry of Healthcare of the Russian Federation, No. 12n, dated 20 June, 2012 [3]

State Control Authority means the state authority with the authorization on the federal level for execution of safety monitoring functions in relation to medical devices (Roszdravnadzor) [2].

Healthcare organizations means medical organizations (facilities), pharmaceutical organizations and other organizations executing business activities in the field of healthcare (Developed while considering Article 29 of the Federal Law no. 32З-FZ [1]).

Harm means loss or damage caused to the people’s health, or to the property, or to the environment [7].

Serious harm (serious deterioration of health) means:

  • Life-threatening disease or injury;
  • Permanent damage to the anatomical structure of the body or to general bodily functions;
  • The need to execute surgery or similar medical intervention in order to prevent irreversible or permanent harm [6], [11].

Danger means a potential source of harm [7].

Risk means the probability of harm or an increase of the severity of the condition caused by the already existing harm [7], [8].

Threat to the personal health and life means the risk of the following:

  • Death,
  • Significant deterioration of health,
  • Disruption of foetal functions, death of the foetus/embryo, congenital abnormality or birth injury.

Safety of the medical device means the absence of unacceptable risk provided the device concerned is used in the way and under the conditions prescribed by the manufacturer [7].

Preservation of the operational functionality of the medical device guarantees its safety.

Device identification means identity confirmation, i.e. the establishment of adequate evidence of consistency of the significant features of the device in question, which allows the device to be related to the specific technical data sheets and/or operational documentation and registration dossier, including its brand, model code, serial number (batch number) and name of the manufacturer. (Developed on the basis of the Federal Law № 184-FZ [8]).

Traceability means the ability to trace the history, usage or location of the medical device [9].

Adverse event (accident) means any side effects not mentioned in the instructions for use or operator’s guide 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 [6], [1].

Safety notification means notification from the manufacturer or its authorized representative to the State Control Authority submitted in order to inform about an adverse event occurring within the country or abroad, which is related to the medical device manufactured by the said manufacturer, or introduced, or already existing and circulating within the territory of the Russian Federation.

Safety notice means a specific notice or report by the manufacturer or its authorized representative send to the entities executing circulation of the medical devices in consideration of a specific safety topic or issue with the medical device in question [10].

Notices of this kind may relate to a single medical device and adverse event pertaining to it, or may consider a group or set of medical devices (such as a specific lot or list of serial numbers) which are the addressees of this specific corrective action or measure.

4.The procedure for safety monitoring

Evaluation of medical device safety in the post marketing period is just as important as control and evaluation of Comorbidity during the initial marketing release, since this process involves feedback (information about accidents/events, quality and efficiency of the device under specific practical conditions).

Safety monitoring is a part of the quality management system and can be isolated as an individual task on the basis of process-oriented approach 180 9000 [9].

In the course of implementing legal requirements related to the safety monitoring of medical devices, the manufacturers or their authorized representatives are advised to collect, process and analyze incoming signals regarding any adverse events occurring during usage or operation of the medical devices concerned.

For the purposes of safety monitoring, including prevention of threats to life and health which may result from the usage or operation of medical devices, it is recommended to ensure identification and traceability of the device in question in order to be able to evaluate any need for regulative actions or to determine the user groups to be addressees of those actions.

It is recommended also for the manufacturer or its authorized representative to establish an officer responsible for interactions with the state control authority, healthcare organizations, medical device users and other entities executing circulation of medical devices; this employee is usually known as the Safety Officer for medical devices.

4.1.Forms for the reporting of adverse events

Reporting of an adverse event does not imply any liability for the related accident or its possible consequences for the manufacturer or its authorized representative.

According to the requirements of Federal Law No. 323-FZ, the manufacturer and its authorized representative shall report to Roszdravnadzor any adverse events not mentioned in the instructions for use or operator’s guide 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.

The threat to health and life may include any event of that kind which results from the defects or non-compliance occuring in the instructions for use, or issues during operation of the medical device, or which may result from user error.

AE notification might be one of the following three types:

  • Primary notification, containing information and details about first occurrence of the AE in question
  • Follow-up or additional notification containing additional or more detailed information regarding the registered AE which was not available at the moment of the primary notice.
  • Final notification containing finalized information about the AE concerned based on the findings of the investigation conducted by the manufacturer (this final report might be a part of the primary report as well).

Final notification may also contain a detailed explanation (report) of the investigation performed on the basis of the findings pertaining to the AE concerned.

Notification is the form of a documented AE report in the event of an AE occurring in the country of circulation or abroad related to the medical device circulating within the territory of the Russian Federation; it is issued in order to inform the state control authority, register the event and implement a set of measures and actions intended for clarification of the immediate cause, mitigation of consequences and prevention of re-occurrence of the said adverse event. This report form is common for any entity executing circulation of medical devices.

Please refer to the Appendix for the contents of the AE Notification and recommendation for its completion.

An electronic form of notification is preferred over any other forms; this could be done via personalized access to the information source (database) “Monitoring of medical devices” implemented in the AIS of Roszdravnadzor.

In order to obtain personalized access to the aforementioned source of the Roszdravnadzor AIS, the Safety Officer for medical devices shall be registered in the system as per the procedure described in Roszdravnadzor info letter No. 04I-749/12 dated 15 August, 2012 (please use the link http://roszdravnadzor.ru/i/upload/files/1345038601.55156-31189.pdf).

The message can be sent in the form of an e-document to the email address mdvigilance@roszdravnadzor.ru, as well as by paper copy to the address Slavyanskalya ploshad, 4, building 1, Moscow, Russia, 109074.

4.2.Procedure for taking a decision on notification

A decision on an AE report (notification) shall be taken only when all three primary criteria are met:

  • The event involved a device made by the manufacturer concerned,
  • The event is immediately related to the device,
  • The event resulted or might result in personal harm, including death or major injury.

Those criteria define the further procedure as follows:

1. When the manufacturer receives information from any source regarding its devices involved in any events, the causal relationship between the device in question and the event shall be assessed in the first instance.

This causal relationship between the device and event may be assessed on the basis of the following considerations:

  • Opinion of the healthcare expert,
  • Information related to the previous similar events,
  • Claim trends (complaints, queries),
  • Any other relevant information available.

 

2.Provided such a relationship is established, it must be determined (based on the available information) whether the event resulted in any harm to health, or whether there is a possibility of such harm, including death or major injury, in the event of re-occurrence.

3.In the event that all decision criteria are met for notification, it shall be made and submitted with all information which potentially may affect understanding and assessment of the adverse event concerned.

In the event of doubts, the general rule shall be “better notify than not”.

An AE notification sent by the manufacturer, unlike notifications provided by other entities executing circulation of medical devices, may contain information about actions and measures which the manufacturer has already taken or proposes to take regarding the event in question (in the Appendix).

4. If the manufacturer upon receiving the information about the event cannot precisely establish the causal relationship between the device and the event, nevertheless a Primary Notice must be submitted promptly (see par. 4.3).

In this case detailed information will be provided in the additional AE notifications, if any.

4.2.1. Furthermore, the manufacturers of medical devices shall notify Roszdravnadzor within the time-frame set forth in par. 4.3 about the following conditions and circumstances:

  • Product recall,
  • Termination of production,
  • Device returned to the manufacturer,
  • Device modifications (including software and documentation),
  • Device exchanged for another one, including due to quality issues,
  • Device disposal,
  • Any additional recommendations from the manufacturer regarding usage of the device concerned (e.g., the device has already been taken off the market or from production, but might still be in use, such as implants),
  • Decision of foreign regulatory bodies applying restrictions on the circulation of medical devices.

All the aforementioned information may be presented to Roszdravnadzor by the manufacturer either in the form of AE notification or in the form of a plain notification letter.

4.3.Time-frames for reporting adverse events

As per Order of the Ministry of Healthcare of the Russian Federation No. 12n dated 20 June, 2012 [3], any information related to adverse events shall be submitted to Roszdravnadzor within 20 days.

This requirement is common for all entities executing circulation of devices and applies to messages about known AE facts which have to be submitted as Notifications (see par. 4.1.). There are no deadlines for Safety Notices (see par. 4.5) and Safety Reports (see par. 4.4) however the manufacturer, when making its own decision on the terms of such communication, shall take into account the possible importance of the related information for the prevention of possible adverse events, and shall consider the severity of the possible harm which may arise due to lack of information.

The time-frame for notifying Roszdravnadzor begins from the date at which the manufacturer receives information which allows the following:

  • Identification of the device involved,
  • Identification of the sender,
  • Description of the nature of the AE and its consequences.

In order to ensure the protection of the health and life of persons who are subject to the circulation of the medical devices concerned, information regarding a serious AE shall be provided as soon as possible.

Time-frames for reporting adverse events information:

Type of event Time-frame for reporting
Serious threat to public health is any type of the event resulting in unavoidable risks of death, major injury or disease which may require urgent actions to resolve. Immediately after a causal relationship has been established between the AE and the medical device in question, but no later than 2 days after the date at which the manufacturer had been informed about the event.
Death or major harm to health (life-threatening disease or injury;

permanent disruption of the body’s anatomical structure or bodily function; the need for medical intervention in order to prevent permanent damage)

 Immediately after a causal relationship has been established between the AE and the medical device in question, but no later than 10 days after the date at which the manufacturer had been informed about the event.
Any other events (all adverse events for which there is no need to report asap) Soon after a causal relationship has been established between the AE and the medical device in question, but no later than 20 days after the date at which the manufacturer had been informed about the event.

4.4.      Actions of the State Control Authority

According to the Statute on State control of the circulation of medical devices implemented by Order of the Government of the Russian Federation No. 970 dated 25 September, 2012, par. 13, in the event of a threat to the health and life of individuals and healthcare personnel, the State Control Authority takes a decision on suspending the use of the medical device involved.

The officers of the State Control Authority ensure sampling of the medical devices involved and organize tests of those samples in expert organizations according to the legislation of the Russian Federation.

Copies of the test results for the medical devices involved are to be sent to the manufacturer of the said device or to its authorized representative, and to the individual citizen, legal entity and/or entrepreneur from which the device in question was taken for testing.

If the facts and circumstances posing a threat to the life and health of the general population and healthcare providers due to the use and operation of the medical devices involved are firmly established and confirmed by the results of related tests, the State Control Authority undertakes actions for the prevention of the violations.

As per part 6 of Article 96 of Federal Law No. 323-FZ, such actions constitute the suspension of use or termination of circulation of the medical device involved based on the decision of Roszdravnadzor.

The State Control Authority decides on the renewal of usage of the medical device in question when the facts and conditions posing a threat to the life and health of the general population and healthcare providers due to the use and operation of medical devices involved are not confirmed by the results of related tests.

Along with the aforementioned, the manufacturer of the medical device may provide its own investigation findings pertaining to the AE in question to Roszdravnadzor, along with the results of expert reviews and testing, as well as a report of its own actions undertaken in order to protect the life and health of patients and healthcare providers. This information might be provided in the form of an additional or closing AE Notification, Safety Notice or Safety Report.

4.5.      Safety notices for medical devices

In order to protect the life and health of the general population, the manufacturers of the medical devices can share with the entities executing circulation of medical devices information regarding new data and additional actions on the improvement of medical devices safety, particularly regarding actions undertaken by the manufacturer in order to ensure medical device safety, and regarding actions taken by foreign regulatory authorities in relation to the medical device concerned.

For this purpose, the manufacturer may distribute so called Medical Device Safety Notices (hereinafter – Notices).

Notice may be issued because of identification of an adverse event, and because of facts and circumstances named in par. 4.2.2 of these Recommendations.

The following information may be included in the Notice:

  • A clearly visible header saying “Safety Notice” placed on the body of the notice, if it is send in paper form by regular mail or by fax message, or in the header of the email:
  • When the Notice is related to adverse events, the numbers of the related register entries according to

Roszdravnadzor AIS,

  • Statement of addressees category, for which the Notice is intended,
  • Identification of the device involved (named of the model, serial No., batch No.),
  • Summary of measures and actions to be undertaken in order to ensure device safety, including a description of the safety issue and its causes;
  • Clear statement of possible safety issues due to incorrect functioning of the device involved or its non-compliance with the established requirements,
  • List of actions recommended to be undertaken by the Notice receiver, including recommendations for persons who were using this device previously or who operated it previously,
  • If necessary, a deadline to implement the aforesaid actions (for both the manufacturer and user),

Contact details of the Safety Officer, in order to obtain further information regarding safety issues.

We recommend a copy of this Notice to be sent to Roszdravnadzor.

The Notice shall not contain any information of a promotional nature, nor purportedly false information regarding the quality, efficiency and safety of the medical device in question.

It is recommended to include references to the information sources in the Notice.

5.           References

1 Федеральный закон от 21.11.2011 № 323-ФЗ «Об основах охраны здоровья граждан в Российской Федерации» (Federal Law No. 323-FZ dated 21 November, 2011 “On the fundamentals of public healthcare in the Russian Federation”).
2 Установление Правительства Российской Федерации от 25.09.2012 № 970 «Об утверждении Положения о государственном контроле за обращением медицинских изделий» (Order of the Government of the Russian Federation No. 970 dated 25 September, 2012 “On approval of the Statute on State Control of the circulation of medical devices”).
3 Приказ Министерства здравоохранения Российской Федерации от 20.06.2012 № 12н «Об утверждении Порядка сообщения субъектами обращения медицинских изделий обо всех случаях выявления побочных действий, не указанных в инструкции по применению или руководстве по эксплуатации медицинского изделия, о нежелательных реакциях при его применении, об особенностях взаимодействия медицинских изделий между собой, о фактах и об обстоятельствах, создающих угрозу жизни и здоровью граждан и медицинских работников при применении и эксплуатации медицинских изделий» (Order of the Ministry of Healthcare of the Russian Federation No. 12n dated 20 June, 2012, “On approval of the Procedure for reporting any adverse events not mentioned in the instructions for use or operator’s guide 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 by the entities executing the circulation of medical devices”).
4 Постановление Правительства Российской Федерации от 30.06.2004 № 323 (в редакции постановления Правительства РФ от 19.06.2012 № 614) «Об утверждении Положения о Федеральной службе по надзору в сфере здравоохранения» (Order of the Government of the Russian Federation No. 323 dated 30 June, 2004 (amended as Order of the Government of the Russian Federation No. 614 dated 19 June, 2012) “On approval of the Statute on the dcc Federal Service for Surveillance in Healthcare”).
5 ГОСТ Р ИСО 15225-2003 – Номенклатура. Номенклатура данных по медицинским изделиям для информационного обмена (GOST R ISO 15225-2003 Nomenclature. Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange).
6 ГОСТ Р ИСО/ТС 19218-2008 – Изделия медицинские. Структура кодов видов и причин неблагоприятных событий (GOST R ISO TC 19218-2008 Medical devices. Coding structure for adverse event type and cause).
7 ГОСТ Р ИСО/ТС 14971-2009 – Изделия медицинские. Применение менеджмента риска к медицинским изделиям (GOST R ISO TC 14971-2009 Medical devices. Application of risk management to medical devices).
8 Федеральный закон от 27.12.2002 № 184-ФЗ «О техническом регулировании» (Federal Law No. 184 FZ dated 27 December, 2002, “On technical regulation”).
9 ГОСТ Р ИСО 9000-2001 – Системы менеджмента качества. Основные положения и словарь (GOST R ISO 9000-2001. Quality management systems. Fundamentals and vocabulary).
10 GHTF/SG2/N57R8:2006 – FD – Medical Devices Post Marketing Monitoring: Content of Field Safety Notices.
11 GHTF/SG2/N54R8:2006 – FD – Medical Devices Post Marketing Monitoring: Global Guidance for Adverse Event Reporting for Medical Devices.
12 GHTF/SG1/N055:2009 – Definitions of the Terms Manufacturer, Authorized Representative, Distributor and Importer.

Appendix to the Procedure for safety monitoring of medical devices for manufacturers/marketing authorization holders

 

The procedure for completion of an Adverse Event Notification

Please find the template for the Notification below.

Each field shall be completed without any abbreviations, by clear handwritten or typed/printed text in Russian.

All information shall be comprehensive, accurate and up to date (to the maximum possible extent).

When the options are provided in the field, please mark the related item or items (if multiple choice is available), and if necessary, add some written explanations.

Information regarding the medical device involved must be provided on the basis of the available documentation such as device technical data sheet, record form, copy of MAC, conformity certificate, operator guidebook, warranty ticket etc.

In order to identify the person involved in the AE (Person involved ID), please use SNILS or personal ID number (in this case please state the type of identification document).

In order to identify the healthcare provider involved in the AE (Healthcare provider ID), please use the person`s code from the healthcare providers register, INN, or SNILS (please state which type of code was used).

Full name of the person involved, healthcare provider and/or individual user, addresses of the person involved or individual user can also be included only with the clear consent of the aforementioned persons given in accordance with Federal Law No. 152 FZ dated 27 July, 2006 “On personal data”.

In order to identify the device involved, please state its brand name, device name (if any), model, serial No., or batch no., number in the State Register of Medical Devices or the number of its marketing authorization certificate.

To identify the organization or company (manufacturer, healthcare or pharmaceutical organization, service company etc.) please use its name, legal address, INN or OGRH code (please state the type of code used).

Contact data shall include the phone number, email address, full name of the contact person, provided in order to receive further information about the AE in question.

The minimum data necessary to complete AE notification are set out in Order of the Ministry of Healthcare of the Russian Federation No. 12n dated 20 June, 2012 [3]:

  1. Information regarding entities executing the circulation of medical devices:

а) for legal entities: full name and form of organization, registered address,

b) for individuals, including entrepreneurs: full name (patronimic name also, if applicable), address,

c) contact phone no.

d) email (if applicable)

2. Name of the medical device involved in the AE, stating its factory ID No.

3. Medical device manufacturer`s name.

4. Description of the AE (if applicable).

If necessary, additional information might be attached on a separate page.

 Notification form – by link.