COMMON MARKET OF MEDICAL DEVICES OF
THE EURASIAN ECONOMIC UNION:
DECISIONS OF THE COUNCIL OF THE EURASIAN ECONOMIC COMMISSION
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On 17 May 2016, on the official website of the Eurasian Economic Union (EAEU)
a number of decisions of the Council of the Eurasian Economic Commission (EEC)
were published, which had been adopted in order to ensure the functioning of
the common market of medical devices in accordance with the EAEU Treaty and
the Agreement on the Uniform Principles and Rules for the Treatment of Medical
Devices (medical devices and medical equipment) within the Eurasian Economic Union
dated 23 December 2014.
The relevant decisions were prepared by the Working Group formed at the EEC Board
with the participation of representatives of the competent state authorities and
pharmaceutical businesses of the EAEU member-states.
The decisions shall come into force after 10 calendar days after the entry into force of
the Protocol on the accession of the Republic of Armenia to the Agreement on
the uniform principles and rules for the treatment of medical devices (medical devices
and medical equipment) within the Eurasian Economic Union dated 2 December 2015,
but not earlier than 10 calendar days after their official publication.
It is expected that the common market of medical devices within the EAEU will start
functioning in full format before the end of this year.
1. The Decision of the EEC Council No. 26 dated 12 February 2016 'On
a Special Mark of the Medical Devices Circulation on the Market of
the Eurasian Economic Union'
The Decision No. 26 approved the image of a special mark of medical devices
circulation on the market and EAEU and Regulations thereon.
The special mark of circulation indicates that the medical device underwent
the procedure of registration and verification of compliance with the common safety and
efficiency requirements established in the EAEU as well as the with the requirements for
the maintenance of quality management system for medical devices.
Manufacturers of medical devices (or authorised representatives thereof) will have to
label devices with the mark before releasing them into circulation within the EAEU.
2. The Decision of the EEC Council No. 27 dated 12 February 2016 'On
Approval of the Common Requirements on Safety and Efficiency of Medical
Devices, Requirements for Their Labelling and Operating Documents
Thereto'
The Common Requirements establish, in particular, that medical devices must be
developed and manufactured so that when used under the respective conditions and for
their purposes specified by the manufacturer, and if required in a view of the technical
knowledge, experience, education or special training, clinical and a user's physical
condition, they should have an effect in accordance with the purposes specified by
the manufacturer and should be safe for the user and the third parties, provided that the
risk associated with their use is acceptable as compared to the benefit to the user.
The interchangeability of medical devices through the use of special technical or
software, or other means shall not be restricted.
Moreover, medical devices must be developed, manufactured and packed so that their
efficiency and performance are not infringed during transportation and storage in
accordance with instructions for use.
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Each medical device shall be accompanied with the information necessary to identify
the device and its manufacturer, country of origin, as well as the information for the user
(professional or non-professional) regarding the safety of the medical device, its
functional and performance properties.
With respect to (a) medical devices for the diagnostics in vitro, and (b) other medical
devices separately common requirements of safety and efficiency are established,
including, in particular, the requirements with regard to:
chemical, physical and biological properties of the medical devices;
infection and microbial contamination of the medical devices;
protection from radiation, mechanical and thermal risks, risks arising to the user
from the supplied energy or substances, the risks arising from the use of medical
devices intended by the manufacturer for the use by users, who do not have
special medical education, the risks posed by medical devices for the diagnostics
in vitro intended for self-testing by users or testing near users;
labelling of medical devices;
information contained in the instructions for use of the medical device.
Manufacturers may provide for compliance of a medical device with the Common
Requirements either by complying with these requirements directly or by complying with
the standards included into the list of standards compliance with which on a voluntary
basis fully or partially results in the compliance of the medical device with the Common
Requirements. The procedure for formation of such a list shall be determined by
the EEC recommendation.
3. The Decision of the EEC Council No. 28 dated 12 February 2016 'On
Approval of the Rules for Technical Testing of Medical Devices'
According to the Rules, the technical testing shall be conducted to determine
the compliance of medical devices with the Common Requirements of safety and
efficiency, requirements for their labelling and operational documentation approved by
the EEC.
In the course of such technical testing, the standards included in the list of standards
compliance with which on a voluntary basis fully or partially results in the compliance of
the medical device with the Common Requirements (hereinafter - the 'List of
Standards'), as well as the technical documentation of the medical device manufacturer
can be applied.
In the absence of such standards, the testing methods (techniques) certified (validated)
and approved in accordance with the laws of the EAEU member-states can be used to
conduct technical testing of medical devices.
Technical testing of a medical device shall be conducted upon applications from
manufacturers of medical devices or authorised representatives thereof in
the institutions, organisations and enterprises, which are included by the competent
authorities of the EAEU member-states into the list of organisations eligible to conduct
researches (testing) of medical devices for their state registration.
Technical testing is not required with respect to medical devices for the diagnostics in
vitro (reagents, reagent kits).
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These Rules provide for the requirements for the authorised institutions (testing
laboratories (centres)) and the procedure for assessment of their compliance with
the specified requirements.
4. The Decision of the EEC Council No. 30 dated 12 February 2016 'On
Approval of the Procedure for Formation and Maintenance of Information
System in the Area of Medical Devices Circulation'
The Decision No. 30 provides for the formation of an information system in the area of
medical devices circulation (hereinafter - the 'Information System'), which is intended to
create the conditions to ensure the circulation of safe, quality and effective medical
devices within the EAEU.
The Information System is a part of the integrated information system of the EAEU
(hereinafter - the 'Integrated System') and includes the following information resources:
1) the unified register of medical devices registered in the EAEU;
2) the unified register of authorised organisations entitled to conduct researches
(testing) of medical devices for the purpose of registration;
3) the unified database on the examination of safety, quality and efficacy of medical
devices.
Any interested parties can get access to the information published on the common
information resources through the information portal of the EAEU for free.
Information about medical devices being under the registration procedure as well as
materials of registration dossier, except for the instructions for use of the registered
medical devices and images of their labelling, refer to the confidential information, is
placed in the information systems of the competent authorities (expert organisations)
and shall be only available to other interested competent authorities (expert
organisations).
The access of competent authorities (expert organisations) to the information contained
in the information system of another competent authority (expert organisation) shall be
granted by referring to the information systems of the competent authorities (expert
organisations) with the use of the Integrated System.
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Best Regards,
GRATA International (Moscow)
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International website. This information should not be acted upon in any specific
situation without appropriate legal advice.
What we do:
Advising on the requirements and restrictions in connection with import and
circulation in Russia of certain goods (i.e. vehicles, FMCG, medicines and
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medical devices), including the requirements for certification/declaration of
compliance, state registration, sanitary and epidemiological examination;
Advising and legal support in participating in public procurement;
Advising on legal compliance of advertising and marketing materials and
activities, marking, packing, and labels;
Development and review of various commercial contracts;
Legal due diligence of counterparties.
Contacts:
Yana Dianova
Director of the Corporate and Commercial Law Department,
GRATA International (Moscow)
Tel: +7 (495) 660 11 84
E.:[email protected]
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