Decision of the Board of the Eurasian Economic Commission dated December 21, 2016 No. 141
"On the Approval of the Procedure for the Application by the Authorized Bodies of the Member States of the Eurasian Economic Union of Measures to Suspend or Prohibit the Use of Medical Devices that Pose a Danger to Human Life and/or Health, or are of Inadequate Quality, Counterfeit, or Falsified, and for Their Withdrawal from Circulation in the Territories of the Member States of the Eurasian Economic Union"
COUNCIL OF THE EURASIAN ECONOMIC COMMISSION
DECISION
dated December 21, 2016. N 141
ON THE APPROVAL OF THE PROCEDURE
APPLICATION BY THE AUTHORIZED BODIES OF THE STATES -
MEMBERS OF THE EURASIAN ECONOMIC UNION MEASURES
TO SUSPEND OR PROHIBIT THE USE OF MEDICAL
OF LIFE-THREATENING PRODUCTS
AND (OR) HUMAN HEALTH, SUBSTANDARD,
COUNTERFEIT OR FALSIFIED MEDICAL
OF PRODUCTS AND THEIR WITHDRAWAL FROM CIRCULATION IN THE TERRITORIES OF
MEMBER STATES OF THE EURASIAN ECONOMIC UNION
In accordance with Article 31 of the Treaty on the Eurasian Economic Union of May 29, 2014, paragraph 3 of Article 8 of the Agreement on common principles and rules of circulation of medical devices (medical devices and medical equipment) within the Eurasian Economic Union of December 23, 2014, paragraph 93 of Annex N 1 to the Regulations of the Eurasian Economic Commission, approved by Decision of the Supreme Eurasian Economic Council of December 23, 2014 N 98, and in order to implement the decision of the Supreme Eurasian Economic Council of December 23, 2014
1. To approve the attached Procedure for the application by authorized bodies of States members of the Eurasian Economic Union of measures to suspend or ban the use of medical devices that pose a danger to human life and/or health, substandard, counterfeit or falsified medical devices and to withdraw them from circulation in the territories of States members of the Eurasian Economic Union.
2. This Decision shall enter into force upon expiration of 10 calendar days from the date of entry into force of the Protocol signed on December 2, 2015, on the accession of the Republic of Armenia to the Agreement on Uniform Principles and Rules of Circulation of Medical Devices (Medical Devices and Medical Equipment) within the Eurasian Economic Union of December 23, 2014, but not earlier than upon expiration of 10 calendar days from the date of official publication of this Decision.
Members of the Council of the Eurasian Economic Commission:
Approved
By decision of the Council
Eurasian Economic Commission
dated December 21, 2016. N 141
ORDER
APPLICATION BY THE AUTHORIZED BODIES OF THE STATES -
MEMBERS OF THE EURASIAN ECONOMIC UNION MEASURES
TO SUSPEND OR PROHIBIT THE USE OF MEDICAL
OF LIFE-THREATENING PRODUCTS
AND (OR) HUMAN HEALTH, SUBSTANDARD,
COUNTERFEIT OR FALSIFIED MEDICAL
OF PRODUCTS AND THEIR WITHDRAWAL FROM CIRCULATION IN THE TERRITORIES OF
MEMBER STATES OF THE EURASIAN ECONOMIC UNION
1. This Procedure has been developed in order to implement Article 31 of the Treaty on the Eurasian Economic Union of May 29, 2014 and paragraph 3 of Article 8 of the Agreement on Uniform Principles and Rules for the Circulation of Medical Devices (Medical Devices and Medical Equipment) within the Eurasian Economic Union of December 23, 2014 (hereinafter - the Agreement) and establishes the rules for the adoption by the authorized bodies of the member states of the Eurasian Economic Union (hereinafter - member states, the Union) of measures to suspend or prohibit the use of
2. For the purposes of this Procedure, the terms used shall mean the following:
"counterfeit medical device" means a medical device manufactured or in circulation in violation of the intellectual property legislation of a member state of the Eurasian Economic Union;
"substandard medical device" - a medical device that does not meet the general requirements for safety and effectiveness of medical devices, requirements for their labeling, technical and operational documentation for them and cannot be safely used for the intended purpose established by the manufacturer;
"falsified medical device" means a medical device intentionally accompanied by false information on its composition, characteristics and (or) manufacturer.
3. The authorized body of the Member State shall take a decision on suspension or prohibition of use and withdrawal from circulation in the territory of its State of a medical device that is dangerous to life and (or) health of people, substandard, counterfeit or falsified medical device on the basis of the results obtained in the course of state control (supervision) in the sphere of circulation of medical devices or revealed within the framework of monitoring of safety, quality and effectiveness of medical devices.
4. The period for which the use of a medical device is suspended shall not exceed 180 calendar days from the date of adoption of the relevant decision. The specified period may be extended by the authorized body of the Member State in case of necessity to conduct additional examination of safety, quality and effectiveness of the medical device due to revealed negative consequences of its use for the period of such examination.
5. Suspension of use of a medical device may be carried out by an authorized body of a Member State on the basis of an application (with justification) submitted by the manufacturer of the medical device or its authorized representative for the period specified in the application.
6. The authorized body of the Member State shall, within 1 working day from the day of taking a decision on suspension of use of a medical device or on extension of the period of suspension of use of a medical device, place it on its official website in the information and telecommunication network "Internet".
The authorized body of the Member State shall, within 3 working days from the date of taking a decision on suspension of the use of a medical device or on extension of the period of suspension of the use of a medical device, notify the manufacturer of the medical device or its authorized representative by registered mail with acknowledgement of receipt, or in the form of an electronic document signed with an electronic signature, or in electronic form via telecommunication channels of the decision taken, indicating the reasons for and the period of suspension of the use of the medical device and the period of suspension of the use of the medical device. The notification shall be accompanied by copies of the relevant expert reports.
7. The authorized body of the Member State shall take a decision on resumption of use of a medical device in case the facts and circumstances that served as grounds for taking a decision on suspension of use of this medical device are not confirmed by the results obtained in the course of research (testing) of medical device samples and shall notify the manufacturer or its authorized representative of the decision taken.
8. In case the manufacturer or its authorized representative fails to eliminate the circumstances that served as grounds for the decision to suspend the use of a medical device within the term established by the authorized body of the Member State, the authorized body of the Member State shall take a decision to ban the use of the medical device and withdraw it from circulation in the territory of the Member State.
9. In case of detection of counterfeit or falsified medical device in circulation on the territory of of the Member State, the authorized body of the Member State shall carry out the following activities:
a) within 5 working days from the date of establishment of this fact shall notify the owner (supplier and (or) seller) of the medical device of the need to submit to the authorized body of the Member State the medical device (if possible) and the documentation enabling identification of the medical device, and (or) provide the necessary conditions for identification of the medical device by the authorized body of the Member State;
b) identify the medical device in accordance with its labeling, packaging and documentation allowing to identify the medical device, including the following features:
name and location of the manufacturer, country of origin, including the address of the place of manufacture of the medical device;
the name of the medical device;
date of manufacture and expiration date (service life);
batch (series, lot) number;
storage (operating) conditions;
marking with a special circulation mark;
information on registration within the Union (number and date of the registration certificate, name of the authorized body of the Member State that issued the registration certificate);
information on the document establishing requirements to the technical characteristics of the medical device (if any);
c) take a decision on prohibition of use and withdrawal from circulation on the territory of the Member State of a counterfeit or falsified medical device.
10. Within 5 working days from the date of detection of the fact of circulation in the territory of a Member State of a medical device that poses a danger to life and (or) health of people, substandard, counterfeit or falsified medical device, the authorized body of other Member States and the Eurasian Economic Commission shall, using the means of the integrated information system of the Union, notify the authorized bodies of other Member States and the Eurasian Economic Commission of the reasons and terms of suspension or prohibition of the use of the medical device and seizure of the medical device.
11. If necessary, the authorized body of a Member State shall send a request using the means of the integrated information system of the Union to the authorized body of another Member State to obtain additional information related to the fact of identification of a medical device that is dangerous to life and (or) health of people, substandard, counterfeit or falsified medical device.
Submission of information on the basis of the said request shall be carried out by the authorized body of the Member State within a period not exceeding 15 calendar days from the date of receipt of the request.
12. Control of execution of decisions on suspension or prohibition of use of a medical device and its withdrawal from circulation on the territory of a Member State shall be carried out by the authorized body of the Member State in the manner prescribed by the legislation of the Member State.
