Order No. 980n by the Ministry of Health of the Russian Federation

On Approving the Procedure for Monitoring the Safety of medical devices

In accordance with part 5 of article 96 of Federal Law dated 21 November 2011 no. 323-FZ "On Fundamentals of Healthcare of the Russian Federation Citizens" (Collection of Legislative Acts of the Russian Federation, 2011, no. 48, art. 6724) and subclause 5.2.191 of the Statute on 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. 20, art. 2528), I hereby order:

1. To approve the attached Procedure for Monitoring the Safety of Medical Devices.
2. This Order enters into force on 1 January 2021 and shall be valid until 1 January 2027.

Minister

M.A. Murashko

Registered

in the Ministry of Justice

of the Russian Federation

on 2 November 2020
Registration no. 60697

APPROVED
by Order of the Ministry
of Healthcare
of the Russian Federation
dated 15 September 2020 no. 980n

The Procedure for Monitoring the Safety of Medical Devices

1. This Procedure establishes the rules and regulations for the Federal Service for Surveillance in Healthcare (hereinafter 'the Service') to monitor the safety of medical devices registered in accordance with the legislation of the Russian Federation¹, and that are in use on the territory of the Russian Federation, with the exception of the territory of the international medical cluster and the territories of innovative scientific and technological centers (hereinafter 'the monitoring').

The monitoring of the safety of medical devices registered in accordance with Acts constituting the Law of the Eurasian Economic Union, and that are in use on the territory of the Russian Federation, shall be conducted by the Service in accordance with the Ruling of the Collegium of the Eurasian Economic Commission dated 22 December 2015 no. 174 "On Approval of the Rules and Regulations for Monitoring the Safety, Quality and Effectiveness of Medical Devices"².

2. The purpose of monitoring is to identify and prevent 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.
3. Monitoring includes the gathering, processing, registering and analysis of information on side effects not specified in the medical device's instructions for use or operating manual, the 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 registered medical devices (hereinafter 'information on adverse events') and adopting the relevant decisions.
4. The monitoring shall be conducted by the Service and its territorial agencies on the basis of information:

1) on adverse events arising from individuals' use of medical devices in the procedure established by the federal agency's executive body as authorised by the Government of the Russian Federation³;

2) obtained through the exercise of state supervision of the use of medical devices;

3) placed on the official websites of foreign regulatory bodies (agencies) in the sphere of the use of medical devices and of adverse events occurring in other states with medical devices registered on the territory of the Russian Federation;

4) on the safety and clinical effectiveness when using medical devices of the potential risk 3 when used, as well as medical devices implanted in the human body of the potential risk 2 when used, as obtained from the manufacturers of medical devices (their authorised representatives);

5) on adverse events based on implanted medical devices as obtained from the sub-system for conducting specialised registers of patients under separate ICD diseases and citizen categories, from the monitoring by an organization for providing high-tec medical aid and health resort treatment, other information systems intended for the collection, storage, processing and provision of information concerning the activity of medical organizations and the services they provide⁴, as well as from the federal state information system 'The Single Automated Vertically Integrated Informational-Analytical System for the Provision of Socio-Medical Assessment"⁵;

6) provided by the manufacturer of the medical device (its authorised representative) on an adverse event, on corrective measures for the safety of the medical device, advice on the safety of the medical device, notifications of errors committed when using medical devices which have entailed the death or serious deterioration in the health of the user.

5. On the receipt of information specified in clause 4 of this Procedure, the Service:

1) registers the information received in the section 'Adverse Events of Medical Devices' of the Service's automated information system (hereinafter 'the Service's AIS) on the day it is received;

2) within five working days from the day of registering the aforesaid information, notifies the manufacturer of the medical device (its authorised representative) of the need to submit to the Service within ten working days from the day of this notification being received a reasoned statement on the facts outlined in the notification with reports appended, if necessary, on the adverse events and corrective actions.

3) sends the information it has received through the AIS to the federal state budgetary institution under the Service's jurisdiction (hereinafter 'the expert institution').

6. On receiving the information specified in subclause 3 of clause 5 of this Procedure, the expert institution submits to the Service by using the section 'Adverse Events of Medical Devices' in the Service's AIS with subsequent paper submission:

1) within three working days following the receipt of the information, an expert opinion on any cause-and-effect relationship between the use of the medical device and the onset of the adverse circumstances identified, as well as any indications in the medical device's instructions for use or operating manual of the risk of developing the adverse events identified;

2) if necessary, within ten working days from the receipt of the information, an expert conclusion with recommendations on the necessity or non-necessity to conduct monitoring or oversight of the risk of developing the adverse events identified;

7. Following consideration of the reasoned statement by the manufacturer of the medical device (its authorised representative), the expert opinion and, if applicable, the expert conclusion of the expert institution, within ten working days following receipt of the latter document (information), the Service rules:

1) to conduct monitoring in accordance with Federal Law dated 26 December 2008 no. 294-FZ "On Protecting the Rights of Legal Entities and Individual Entrepreneurs under State Monitoring (Oversight) and Municipal Monitoring"⁶and the Statute on State Monitoring of the Use of Medical Devices Approved by Decree of the Government of the Russian Federation dated 25 September 2012 no. 970 ⁷, or the lack of any grounds for conducting this monitoring;

2) on the necessity of adopting measures to prevent harm being caused to the life and health of individuals when using the medical device for the period of time needed for verification, by suspending the use:

of the medical device if information on adverse events has been received with reference to two and more models (variants) of the medical device;

of a model (variant) of the medical device if information has been received on adverse events with reference to two and more batches (series) of the medical device of one model (variant);

of a batch or series of the medical device if information has been received on adverse events with reference to a batch (series) of the medical device.

8. In the event that during the monitoring facts are confirmed that harm has been caused to the life and health of individuals with the use of the medical device, the manufacturer of the medical device (its authorised representative) shall, within a period of time not exceeding ten working days from when the information from the Service has been received, develop and send to the Service, inter alia through the Service's AIS, a program of measures to be agreed to prevent harm being caused to the life and health of individuals and medical workers when using the medical device (hereinafter 'the Program').

The Program should include measures to warn medical device users, including individuals and medical workers, that using the medical device may cause harm to the life and health of individuals, an analysis of the causes of the adverse event while factoring in any earlier information on adverse events, the means to prevent the aforementioned harm, as well as a time frame for implementing such measures.

9. The Service shall, within ten working days following receipt of the Program, send it via the Service's AIS to the expert institution for the formulation of a conclusion, within fifteen working days following receipt of the Program, on the adequacy of the proposed measures to prevent harm to the life and health of individuals and medical workers when using the medical device.
10. The Service shall, within ten working days following receipt of the conclusion specified in clause 9 of this Procedure, send inter alia via the Service's AIS to the manufacturer of the medical device (its authorised representative) a notification that the Program has been agreed, or a notification of the need to make amendments to the Program specifying such amendments.
11. The manufacturer of the medical device (its authorised representative), on receiving notification of the need to make amendments to the Program within ten working days after receipt of this notification, shall submit to the Service a Program with due account taken of the amendments, for renegotiation.
12. During the period of monitoring specified in subclause 1 of clause 7 of this Procedure of the Program's development and its agreement, the manufacturer of the medical device (its authorised representative) shall undertake measures to ensure that the harm caused by handling the medical device is not exacerbated.

For the entire duration of the Program the manufacturer (its authorised representative) shall enable purchasers, including end-users, to receive updated information on the measures specified in paragraph 1 of clause 12 of this Procedure.

13. The Service's rulings, specified in subclause 2 of clause 7 of this Procedure, shall be retracted, inter alia following the Service's approval of the report by the manufacturer of the medical device (its authorised representative) on the Program's execution, with supporting documents appended, including tests of the medical device performed in a laboratory accredited in the National System of Accreditation⁸.
14. In the event that the manufacturer of the medical device (its authorised representative) does not accept the measures specified in clause 12 of this Procedure, the Service is entitled to rule on withdrawing the medical device, its model (variant), batch and series from use.
15. When the Service receives information on an adverse event in accordance with subclauses 2-6 of clause 4 of this Procedure, monitoring shall be performed in accordance with subclause 3 of clause 5, and with clauses 6-14, 16 and 17 of this Procedure.
16. Information on the Service's rulings in connection with the monitoring of the safety of medical devices is available on the Service's official website on the Internet, observing the restrictions as set out by the legislation of the Russian Federation on personal data, trade secrets and (or) state secrets, and (or) other legally protected secrets.
17. Failure to submit to the Service a Program and information stipulated by this Procedure, as well as the submission of manifestly inaccurate information, shall incur administrative liability in accordance with article 19.7.8 of the Russian Federation Code on Administrative Offences⁹.

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1. 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).
2. Official site of the Eurasian Economic Union http://www.eaeunion.org/, 30 December 2015.
3. Part 3 of article 96 of Federal Law dated 21 November 2011 no. 323-FZ "On Fundamentals of Healthcare of the Russian Federation Citizens" (Collection of Legislative Acts of the Russian Federation, 2011, no. 48, art. 6724), subclause 5.2.191 of the Statute on the Ministry of Healthcare of the Russian Federation, 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. 20, art. 2528).
4. Clause 4 of Section III 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 (Collection of Legislative Acts of the Russian Federation, 2018, no. 20, art. 2849).
5. Clause 51 of Section VIII 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 (Collection of Legislative Acts of the Russian Federation, 2018, no. 20, art. 2849).
6. Collection of Legislative Acts of the Russian Federation, 2008, no. 52, art. 6249; 2020, no. 14, art. 2028.
7. Collection of Legislative Acts of the Russian Federation, 2012, no. 40, art. 5452; 2019, no. 47, art. 6667.
8. Federal Law dated 28 December 2013 no. 412-FZ "On Accreditation in the National System of Accreditation" (Collection of Legislative Acts of the Russian Federation, 2013, no. 52, art. 66977; 2018, no. 31, art. 4851).
9. Collection of Legislative Acts of the Russian Federation, 2002, no. 1, art. 1; 2013, no. 48, art. 6165.