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.
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).
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:
- the unified register of medical devices registered in the EAEU;
- the unified register of authorised organisations entitled to conduct researches (testing) of medical devices for the purpose of registration;
- 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.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.