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

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

Registered with the Ministry of Justice of Russia on November 2, 2020. No. 60697

 

MINISTRY OF HEALTHCARE OF THE RUSSIAN FEDERATION
ORDER
dated September 15, 2020 No. 980n

 

ON APPROVAL OF THE PROCEDURE FOR MONITORING THE SAFETY OF MEDICAL DEVICES

Pursuant to Part 5 of Article 96 of Federal Law No. 323-FL dated November 21, 2011 “On the Fundamentals of Health Protection of Citizens in the Russian Federation” (Collection of Legislation of the Russian Federation, 2011, No. 48, Art. 6724) and subparagraph 5.2.191 of the Regulation on the Ministry of Healthcare of the Russian Federation, approved by Decree of the Government of the Russian Federation No. 608 dated June 19, 2012 (Collection of Legislation 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 shall enter into force on January 1, 2021 and shall remain in effect until January 1, 2027.

 

Minister
M.A. MURASHKO
APPROVED

 

by Order of the Ministry of Healthcare
of the Russian Federation
dated September 15, 2020 No. 980n

 

PROCEDURE FOR MONITORING THE SAFETY OF MEDICAL DEVICES

  1. This Procedure establishes the rules for conducting, by the Federal Service for Surveillance in Healthcare (hereinafter referred to as the “Service”), monitoring of the safety of medical devices registered in accordance with the legislation of the Russian Federation and in circulation within the territory of the Russian Federation <1>, with the exception of the territory of the international medical cluster and the territories of innovative scientific and technological centers (hereinafter referred to as “monitoring”).

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<1> Decrees of the Government of the Russian Federation No. 1416 dated December 27, 2012 “On Approval of the Rules for State Registration of Medical Devices” (Collection of Legislation of the Russian Federation, 2013, No. 1, Art. 14; 2020, No. 12, Art. 1792), and No. 430 dated April 3, 2020 “On the Specifics of the Circulation of Medical Devices, Including State Registration of a Batch (Lot) of a Medical Device” (Collection of Legislation of the Russian Federation, 2020, No. 15, Art. 2284; Official Internet Portal of Legal Information, http://www.pravo.gov.ru, June 4, 2020).

 

Monitoring of the safety of medical devices registered in accordance with the acts constituting the law of the Eurasian Economic Union and in circulation within the territory of the Russian Federation shall be carried out by the Service in accordance with Decision No. 174 of the Board of the Eurasian Economic Commission dated December 22, 2015 “On Approval of the Rules for Monitoring the Safety, Quality and Effectiveness of Medical Devices” <2>.

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<2> Official website of the Eurasian Economic Union, http://www.eaeunion.org/, December 30, 2015.

 

  1. The purpose of monitoring is to identify and prevent adverse effects not specified in the instructions for use or operating manual of a medical device, adverse reactions during its use, specific features of interaction between medical devices, and facts and circumstances that create a threat to the life and health of citizens and medical workers during the use and operation of medical devices.
  2. Monitoring includes the collection, processing, registration and analysis of information on adverse effects not specified in the instructions for use or operating manual of a medical device, adverse reactions during its use, specific features of interaction between medical devices, and facts and circumstances that create a threat to the life and health of citizens and medical workers during the use and operation of registered medical devices (hereinafter referred to as “information on adverse events”), and the adoption of appropriate decisions.
  3. Monitoring shall be carried out by the Service and its territorial bodies on the basis of information:

1) on adverse events received from entities involved in the circulation of medical devices in the manner established by the federal executive authority authorized by the Government of the Russian Federation <3>;

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<3> Part 3 of Article 96 of Federal Law No. 323-FL dated November 21, 2011 “On the Fundamentals of Health Protection of Citizens in the Russian Federation” (Collection of Legislation of the Russian Federation, 2011, No. 48, Art. 6724), subparagraph 5.2.191 of the Regulation on the Ministry of Healthcare of the Russian Federation, approved by Decree of the Government of the Russian Federation No. 608 dated June 19, 2012 (Collection of Legislation of the Russian Federation, 2012, No. 20, Art. 2528).

 

2) obtained during the exercise of state control over the circulation of medical devices;

3) posted on the official websites of foreign regulatory authorities (agencies) in the field of medical device circulation, concerning adverse events that occurred in other states involving medical devices registered within the territory of the Russian Federation;

4) on the safety and clinical effectiveness of the use of medical devices belonging to potential risk class 3, as well as medical devices belonging to potential risk class 2б that are implanted in the human body, received from manufacturers of medical devices (their authorized representatives);

5) on adverse events involving implanted medical devices, obtained from the subsystem for maintaining specialized patient registries for individual nosologies and categories of citizens, monitoring the organization of the provision of high-technology medical care and sanatorium-resort treatment, and other information systems intended for the collection, storage, processing and provision of information relating to the activities of medical organizations and the services they provide <4>, as well as from the federal state information system “Unified Automated Vertically Integrated Information and Analytical System for Conducting Medical and Social Expertise” <5>;

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<4> Clause 4 of Section III of the Regulation on the Unified State Information System in the Healthcare Sector, approved by Decree of the Government of the Russian Federation No. 555 dated May 5, 2018 (Collection of Legislation of the Russian Federation, 2018, No. 20, Art. 2849).

<5> Clause 51 of Section VIII of the Regulation on the Unified State Information System in the Healthcare Sector, approved by Decree of the Government of the Russian Federation No. 555 dated May 5, 2018 (Collection of Legislation of the Russian Federation, 2018, No. 20, Art. 2849).

 

6) provided by the manufacturer of the medical device (its authorized representative) concerning an adverse event, corrective actions relating to the safety of the medical device, safety notices concerning the medical device, and reports of errors made during the use of medical devices that resulted in the death of the user or a serious deterioration in the user’s health.

  1. Upon receipt of the information specified in Clause 4 of this Procedure, the Service shall:

1) register the information received in the “Adverse Events Involving Medical Devices” section of the Service’s automated information system (hereinafter referred to as the “Service’s AIS”) on the day of its receipt;

2) within five working days from the date of registration of this information, notify the manufacturer of the medical device (its authorized representative) of the need to submit to the Service, within ten working days from the date of receipt of the notification, a reasoned position on the facts set out in the report, accompanied, where necessary, by reports on adverse events and corrective actions;

3) forward the information received, through the Service’s AIS, to a federal state budgetary institution under the authority of the Service (hereinafter referred to as the “expert institution”).

  1. Upon receipt of the information specified in subparagraph 3 of Clause 5 of this Procedure, the expert institution shall submit to the Service, by completing the “Adverse Events Involving Medical Devices” section of the Service’s AIS, followed by submission in hard copy:

1) within three working days from the date of receipt of the information, an expert opinion on the existence of a causal relationship between the use of the medical device and the occurrence of the identified adverse events, as well as on whether the instructions for use or operating manual of the medical device contain indications of the risk of occurrence of the identified adverse events;

2) where necessary, within ten working days from the date of receipt of the information, an expert conclusion containing recommendations on whether or not control and supervisory measures and regulatory decisions concerning the medical device need to be taken.

  1. Based on the results of consideration of the reasoned position of the manufacturer of the medical device (its authorized representative), the expert opinion and, where available, the expert conclusion of the expert institution, the Service shall adopt a decision within ten working days from the date of receipt of the last document (information):

1) to conduct control measures in accordance with Federal Law No. 294-FL dated December 26, 2008 “On the Protection of the Rights of Legal Entities and Individual Entrepreneurs in the Exercise of State Control (Supervision) and Municipal Control” <6> and the Regulation on State Control over the Circulation of Medical Devices, approved by Decree of the Government of the Russian Federation No. 970 dated September 25, 2012 <7>, or that there are no grounds for conducting control measures;

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<6> Collection of Legislation of the Russian Federation, 2008, No. 52, Art. 6249; 2020, No. 14, Art. 2028.

<7> Collection of Legislation of the Russian Federation, 2012, No. 40, Art. 5452; 2019, No. 47, Art. 6667.

 

2) on the need to take measures to prevent harm to the life and health of citizens during the use of the medical device for the period necessary to conduct the inspection, by suspending the use of:

the medical device, if information on adverse events has been received in respect of two or more models (versions) of the medical device;

the model (version) of the medical device, if information on adverse events has been received in respect of two or more batches (lots) of a medical device of the same model (version);

the batch or lot of the medical device, if information on adverse events has been received in respect of a batch (lot) of the medical device.

  1. If, during control measures, facts of harm being caused to the life and health of citizens during the use of the medical device are confirmed, the manufacturer of the medical device (its authorized representative) shall, within a period not exceeding ten working days from the date of receipt of information from the Service, develop and submit to the Service, including through the Service’s AIS, for approval, a program of measures to prevent harm to the life and health of citizens and medical workers during the use of the medical device (hereinafter referred to as the “Program”).

The Program shall include measures to notify entities involved in the circulation of medical devices, including citizens and medical workers, of the existence of a threat of harm to the life and health of citizens during the use of the medical device, an analysis of the causes of the adverse event, taking into account previously identified reports of adverse events, methods of preventing the aforementioned harm, as well as the time limits for implementing such measures.

  1. Within a period not exceeding ten working days from the date of receipt of the Program, the Service shall forward it through the Service’s AIS to the expert institution for the issuance, within a period not exceeding fifteen working days from the date of receipt of the Program, of a conclusion on the sufficiency of the proposed measures to prevent harm to the life and health of citizens and medical workers during the use of the medical device.
  2. Within a period not exceeding ten working days from the date of receipt of the conclusion specified in Clause 9 of this Procedure, the Service shall send to the manufacturer of the medical device (its authorized representative), including through the Service’s AIS, a notification approving the Program or a notification of the need to amend the Program, specifying such amendments.
  3. Upon receipt of a notification of the need to amend the Program, the manufacturer of the medical device (its authorized representative) shall be obliged, within a period not exceeding ten working days from the date of receipt of that notification, to submit to the Service the Program incorporating the amendments made, for re-approval.
  4. During the period of conducting the control measures specified in subparagraph 1 of Clause 7 of this Procedure, and of developing and approving the Program, the manufacturer of the medical device (its authorized representative) shall take measures to ensure that harm associated with the circulation of that medical device does not increase.

Throughout the entire period of validity of the Program, the manufacturer (its authorized representative) shall ensure that purchasers, including consumers, have the opportunity to obtain prompt information on the measures specified in the first paragraph of Clause 12 of this Procedure.

  1. The Service shall revoke the decisions specified in subparagraph 2 of Clause 7 of this Procedure, including on the basis of the results of the Service’s approval of the report submitted by the manufacturer of the medical device (its authorized representative) on the implementation of the Program, with supporting documents attached thereto, including tests of the medical device conducted in a laboratory accredited within the national accreditation system <8>.

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<8> Federal Law No. 412-FL dated December 28, 2013 “On Accreditation in the National Accreditation System” (Collection of Legislation of the Russian Federation, 2013, No. 52, Art. 66977; 2018, No. 31, Art. 4851).

 

  1. If the manufacturer of the medical device (its authorized representative) fails to take the measures specified in Clause 12 of this Procedure, the Service shall be entitled to decide to withdraw the medical device, its model (version), batch or lot from circulation.
  2. Where the Service receives information concerning an adverse event in accordance with subparagraphs 2–6 of Clause 4 of this Procedure, monitoring shall be carried out in accordance with subparagraph 3 of Clause 5 and Clauses 6–14, 16 and 17 of this Procedure.
  3. Information on decisions of the Service relating to the monitoring of the safety of medical devices shall be posted on the official website of the Service on the Internet information and telecommunications network, subject to compliance with the restrictions established by the legislation of the Russian Federation concerning personal data, commercial and/or state secrets, and/or other secrets protected by law.
  4. Failure to submit the Program or information provided for by this Procedure to the Service, as well as the provision of knowingly false information, shall entail administrative liability in accordance with Article 19.7.8 of the Code of the Russian Federation on Administrative Offenses<9>.

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<9> Collection of Legislation of the Russian Federation, 2002, No. 1, Art. 1; 2013, No. 48, Art. 6165.

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