Functioning of the common market of medical devices within the EAEU is carried out in accordance with the Agreement on the Eurasian Economic Union dated May 29, 2014, Agreement on common principles and rules for circulation of medical devices (medical devices and medical equipment) within the Eurasian Economic Union dated December 23, 2014, as well as in accordance with the acts of the Eurasian Economic Commission in the field of circulation of medical devices.

The main legislative act regulating the registration of medical devices on the territory of EAEU member states is the Decision No. 46 “On the rules of registration and examination of safety, quality and efficiency of medical devices” of February 12, 2016.

Registration of medical devices under the common rules of the Union becomes mandatory from January 1, 2022. During the transition period until December 31, 2021, registration of medical devices at the decision of the manufacturer of medical devices can be carried out according to the national procedure or according to the unified rules of the EAEU.

At the same time, all medical devices registered according to national procedures must be brought into compliance with the EAEU rules by the end of 2021. However, the extension of the period by 5 years or more is under active discussion.

Before a medical device is put into circulation, the manufacturer or its Authorized Representative shall affix a special mark for the circulation of medical devices. The mark is applied to each individual medical device, indicating that it has passed the established procedure of registration and confirmation of compliance with safety and efficiency requirements.

Authorized representative in EAEU 

The non-resident manufacturer should designate an Authorized Representative on the territory of the EAEU. The Authorized Representative may be a legal entity or an individual entrepreneur, who is a resident of the EAEU and authorized by the Power of Attorney to represent the interests of the manufacturer and be responsible for the quality, safety and efficiency of the medical device when it is used in the EAEU territory.

The manufacturer and its Authorized Representative are responsible for the compliance of the medical device with safety and efficiency requirements, labeling requirements and operational documentation.

The Authorized Representative acts as a link between the EAEU common market and a non-resident manufacturer. The name and address of the Authorized Representative shall be affixed on the labeling of the medical device and/or instructions for use. The Authorized Representative should receive claims and inquiries from consumers, competent authorities and conduct post-marketing.

Establishment of registration of the medical device in the EAEU 

Procedure for registration of medical devices on the territory of EAEU Member States, list of necessary documents, timelines and other aspects of the registration process are approved by the Decision of the Council of the Eurasian Economic Commission of February 12, 2016 №46 “On the rules of registration and examination of safety, quality and efficiency of medical devices”.

The registration procedure, classification of medical devices, requirements to the registration dossier and many other aspects may seem similar to the requirements of EU Directives, but actually significantly differ.

General requirements for safety and efficiency of medical devices are set out in the Decision of the Council of the Eurasian Economic Commission of February 12, 2016 № 27 “On approval of General requirements for safety and efficiency of medical devices, labeling requirements and operational documentation for them”. This document is similar to the Annex I to EU Directives 93/42/EEC and 98/79/EC (Essential requirements checklist), but differs in form and combines the requirements for medical devices, medical devices for in-vitro diagnostics and active implantable medical devices.

The legislation approves the following classification of medical devices: I, IIa, IIb, III and in-vitro diagnostic medical devices, which are also divided into 4 classes. All classes of medical devices undergo the same registration procedure, but the list of required documents (scope of evidence) differs from class.

The registration procedure does not start with the filing of the Application and the registration dossier, but with the formation of the evidence base for the safety and efficiency of the medical device. For this purpose it is necessary to conduct preliminary technical and, if necessary, metrological and clinical tests on the territory and according to EAEU rules. Tests are conducted only in the authorized organizations entered into the unified register of authorized organizations of the Eurasian Economic Union.

The test results form a part of the Technical documentation (registration dossier), on the basis of which the examination and registration of the medical device will take place.

The procedure allows for registration in one or several EAEU member states. The country to which the Application for registration of a medical device is submitted is hereinafter referred to as a “reference” country. Competent authority of this country is primarily responsible for examination of the registration dossier and makes a decision on approval or refusal of registration. Other countries, also selected by the Applicant, are referred to as “recognition countries”. Countries of recognition are involved in the examination process and may make observations and/or denials, which will be extended only to the territory of that country.

The registration certificate is issued without expiry. The common register of medical devices contains the user’s manual (instructions for use) and approved labeling mock-ups of the medical device.

Within the assessment (registration) procedure competent authority of any recognition state can reject the conclusions of the expert opinion that will result in refusal to grant authorization for use of the medical device in the territory of such state. In other words, the registration will not be granted in that state.

Registration dossier

Requirements for the registration dossier are described in Annex 4 to the Decision of the Council of the Eurasian Economic Commission of February 12, 2016 № 46 “On the rules of registration and examination of safety, quality and efficiency of medical devices”.

The list of documents required for registration of a medical device depends on the class. According to the Decision of the Board of the Eurasian Economic Commission of December 22, 2015 № 173 “On approval of the rules of classification of medical devices depending on the potential risk of use” the products are divided into the following classes: I, IIa, IIb, III and medical devices for in-vitro diagnostics, which are also classified as I, IIa, IIb, III.

Classification is different from EU: such classes as Is, Im, List “A” and “B” for in-vitro diagnostics, products intended for self-control and procedural kits are missing from the classification. However, the requirements for the registration dossier include special requirements for sterile medical devices, devices with measuring functions, and the classification of in-vitro diagnostic devices also implies different requirements for the products, depending on it’s potential risk.

The list of required documentation includes administrative data (Power of Attorney, various certificates), product description and labeling data, marketing history, incidents and recalls, testing protocols, biologic evaluation protocols, clinical evidence of efficacy and safety, risk analysis data and other documents.

Quality management system of the manufacturer must be certified, in spite of the class.

The dossier is submitted electronically, format requirements and other aspects are specified in the Decision of the Board of the Eurasian Economic Commission No. 78 of June 30, 2017 “On Requirements for the electronic type of applications and registration dossier documents provided during the registration and examination of safety, quality and efficiency of medical devices”. The registration dossier may also be requested in paper form, if any of the countries of recognition has such a requirement.

All documentation provided in a foreign language must be translated into Russian.

Inspections

The manufacturer of the medical device must establish and maintain the quality management system according to the rules and requirements of the EAEU. Requirements to the quality management system depend on the class of potential risk of the product and are described in the Decision of the Council of the Eurasian Economic Commission dated 10.11.2017 No.106 “On approval of Requirements for implementation, maintenance and evaluation of the quality management system of medical devices depending on the potential risk of their use”.

The legislation establishes that when submitting an Application for registration of class IIa (produced in sterile form), class IIb and class III medical devices as part of the registration dossier, documentation confirming that the manufacturer has a quality management system, and copies of certificates of conformity of the quality management system to the requirements of GOST ISO 13485 “Medical devices. Quality management systems. System requirements for regulatory purposes” or other national or international standards.

During the registration procedure the inspection of medical devices production is carried out. Inspection costs are borne by the manufacturer on the basis of an agreement with the inspection organization. A confidentiality agreement is signed prior to the inspection.

The number of inspectors and the duration of the inspection shall be calculated in accordance with Annex 1 to the Eurasian Economic Commission Council Decision No.106. Based on the inspection results, a report is issued, which is valid for 3 years.

After the initial inspection is carried out periodic (scheduled) inspections should be performed once in three years. The schedule of surveillance inspections is published on the official websites of the competent authorities.

Labelling and language requirements 

Medical devices that have undergone the registration procedure in accordance with the requirements of the Eurasian Economic Union have a special circulation mark (symbol). The mark is applied to the medical device by the manufacturer or his Authorized Representative before the product is placed on the market.

The image of the mark, its size and proportions, as well as other requirements are established by the Decision of the Council of the Eurasian Economic Commission of February 12, 2016 № 26 “On the special mark of circulation of medical devices”. The minimum size of the mark is 6 mm in width and 6.42 mm in height.

A special mark is applied to the medical device itself, by any technological method that provides its clear view during its entire life cycle, except in cases of technological impossibility or increased risks to the health and life of the patient.

The mark is not accompanied by any additional data, no identification code of the body, no registration certificate number.

Requirements for labeling of medical devices, instructions for use (user manuals) are described in the Decision of the Council of the Eurasian Economic Commission of February 12, 2016 № 27 “On approval of General requirements for safety and efficiency of medical devices, requirements for their marking and operational documentation on them”.

Labeling is applied to the medical device, and if it is impossible or unreasonable, to the packaging and/or instruction of each individual product. The labeling of the medical device shall contain:

• the name of the medical device,
• data for its identification and intended use,
• manufacturer’s name and address,
• name and address of the Authorized representative of the manufacturer in the EAEU,
• batch number or serial number,
• shelf life (safe usage period),
• year of manufacture, unless an expiration date is specified,
• information about special storage conditions,
• if applicable, information on sterility and the sterilization method,
• if applicable, information about disposable use,
• if applicable – information on product recovery, indicating the current and limit number of cycles,
• other specific data.

Instructions for class I and IIa medical devices can be presented in abbreviated form or on the labeling, if the use of the device is obvious and safe for the user. Instructions for use can be presented both in paper and electronic form, but the way of presenting the information should be available to the intended users of the product.

Introduction of changes 

After the registration of the medical device, the manufacturer is obliged to declare the changes within 2 months from the date of such changes. For this purpose, an Application and a corresponding set of documents shall be submitted to the competent authority of the reference state.

Types of changes and the necessary documentation are described in Annex 8 to the Decision of the Council of the Eurasian Economic Commission of February 12, 2016 № 46 “On the rules of registration and examination of safety, quality and efficiency of medical devices”.

After the expertise, the reference country body takes a decision on making changes, if necessary, it draws up a new registration certificate, places data on the introduction of changes and updated documents in the common register of medical devices.

Post-Marketing

Competent authorities of the EAEU Member States monitor the safety of medical devices placed on the market. The order of monitoring is established by the Decision of the Board of the Eurasian Economic Commission of December 22, 2015 №174 “On approval of the Rules for monitoring the safety, quality and efficiency of medical devices”.

Monitoring includes collection, registration, analysis of information on adverse events (incidents) when medical devices are in circulation in the EAEU.

The manufacturer of medical devices or its Authorized Representative shall submit a report on the adverse event (incident) and a report on corrective actions for safety of the medical device to the authorized body of the Member State of the Union on the territory of which the unfavourable event (incident) occurred within the following terms:

• in case of a serious threat to health immediately, but not later than 2 calendar days after the medical device manufacturer became aware of the threat;
• in case of death or unexpected serious deterioration of the user’s health condition – immediately after the medical device manufacturer has established a connection between the use of the medical device and the event, but not later than 10 calendar days after the medical device manufacturer became aware of the event;
• in other cases – immediately after the medical device manufacturer has established a connection between the use of the medical device and the event, but not later than 30 calendar days after the medical device manufacturer became aware of the event.

Medical organizations operating in the field of circulation of medical devices shall inform the manufacturer of medical devices or its authorized representative about undesirable events that have signs of an unfavourable event (incident), as well as provide access to medical devices with which the said events may be related.

Cratia provides professional services on registration (conformity assessment) of medical devices in EAEU. We have an excellent knowledge of national legislation, necessary experience and resources. 

To start cooperation or get advice, please contact us by phone: +38 068 064-78-31, +38 044 223-61-67, by e-mail: info@cratia.ua, or visit our office.