Medical devices in the Eurasian Economic Union (EAEU)

Category: product safety, compliance Industry: healthcare Year:

Common market for medical devices and medicines in the EAEU now in force

Background

The Eurasian Economic Union (EAEU) is an economic union consisting of Russia, Belarus, Kazachstan, Kyrgyzstan and Armenia. It was established on 1 January 2015. Its purpose consists in economic cooperation between its member states.

Until the establishment of the EAEU, if a manufacturer was planning to license and sell medical devices in one of the states which are now members, he had to go through a separate national registration procedure in each of those states. Now, members of the EAEU have agreed on a common market for medical devices, so that in future a uniform harmonised registration procedure will be sufficient.

New common market

In concrete terms, a joint registration procedure is envisaged for the states of the EAEU. A manufacturer can apply for product registration in one of the member states and license and sell his product following successful registration throughout the EAEU without any further tests. Unlike the procedure in the EU, in which one member country decides on the result of the conformity assessment procedure, the EAEU involves all its member states. 

The registration procedure begins with application by the manufacturer, or by his authorised agent if the manufacturer himself does not have his registered office in the EAEU. The application is to be accompanied by proof of the safety, effectiveness and quality of the medical device. These necessary tests are carried out at authorised EAEU agencies. The registering authority of the state in which the application was made then enters the application in the common information system of the EAEU, so that the other states can also take part in the procedure. On the basis of an expert report, drawn up by the registering authority, a decision is taken as to whether the medical device complies with the requirements and is thus fit for registration. The remaining member states can approve a positive expert report, and if they do so that leads to the registration of the medical device in all member states. However, a remaining member state can also refuse its approval. If such refusal cannot be reconsidered and changed with the aid of a mediation panel, the medical device cannot be registered in the member state which refused its approval. The product is then registered only in those countries which have approved the expert report.

The outlook

As regards the safety, effectiveness and quality of his product, the manufacturer must at the very least meet the recommended common standards of the EAEU. Currently, the list of common standards is still being drafted, so there is at present no clear definition of the specifications that have to be met. The common information system is still in the development phase too. 

Until the final definition of standards and requirements and the implementation of the information system, notwithstanding the common market that has now come into force, registration is not possible. Until expiry of a transitional period which runs until 31 December 2021, medical devices are thus still to be registered in accordance with the individual national procedures.

[November 9th, 2017]