Registration of Medical Devices under the Rules of the EAEU
Registration of medical devices according to the rules of the Eurasian Economic Union.
Registration of medical devices is a mandatory step for their subsequent circulation on the market, both in the Russian Federation and within the Eurasian Economic Union (EAEU). Currently, the actions of the legislator are aimed at unifying the rules for registering medical devices in the EAEU member states. From the beginning of 2023, the registration of medical devices will be carried out only in accordance with the Rules for the Registration and Examination of the Safety, Quality and Efficacy of Medical Devices, approved by the Resolution of the Council of the Eurasian Economic Commission dated February 12, 2016 N 46. procedures will be valid for the period of validity specified in the registration certificate.
A medical device must comply with the General Requirements for the Safety and Efficacy of Medical Devices, the requirements for their labeling and operational documentation for them, approved by the Resolution of the Council of the Eurasian Economic Commission dated February 12, 2016 N 27, according to which it must be effective within the characteristics declared by the manufacturer. Also, for each medical product, information on its safety and functional properties should be provided.
Registration is possible in one of the EAEU states (the reference state in which the examination of the medical device will be carried out) with the choice of at least 1 state of recognition (the state in which the expert opinion prepared in the reference state will be coordinated.
The complexity of the procedure for registering a medical device depends on the hazard class determined in accordance with the Rules for the Classification of Medical Devices Depending on the Potential Risk of Use, approved by the Decision of the Eurasian Economic Commission dated December 22, 2015 N 173 Medical devices, depending on the degree of potential risk of use, are divided into 4 class. Classes are labeled 1, 2a, 2b and 3.
Classification of medical devices is carried out on the basis of the following:
- class 1 includes medical devices with a low degree of potential risk of use;
- class 2a includes medical devices with an average degree of potential risk of use;
- class 2b includes medical devices with an increased degree of potential risk of use;
- Class 3 includes medical devices with a high degree of potential risk of use.
For registration with the authorized body (expert organization) the following shall be submitted:
- an application for registration and a power of attorney for the signatory of the application;
- registration dossier containing applications for registration and examination;
- manufacturer's contract with an authorized representative of the manufacturer;
- a copy of the authorization document for the right to manufacture in the country of origin;
- a copy of the document or information confirming the registration of the manufacturer as a legal entity or individual entrepreneur;
- a copy of the certificate of conformity of the quality management system with the requirements of the ISO 13485 standard or the relevant regional or national (state) standard of the EAEU member state;
- labeling and packaging data (full-color (with color coding) layouts of packages and labels), labeling text in Russian and official languages of the EAEU Member States;
- schemes of production processes, main stages of production, packaging, testing and procedure for the release of the final product;
- reports of accidents and recalls;
- a list of standards that were applied in the design and production;
- technical test reports and/or test reports for the evaluation of biological activity;
- a report on the assessment of the biological effect and/or reports on clinical evidence of the effectiveness and safety of a medical device and/or clinical trial (study) and/or risk analysis and management;
- copies of documents confirming payment for registration and examination procedures in the reference state;
- other documents provided depending on the type of medical device being registered.
After submitting the application and the necessary documents to the authorized body of the reference state, the authorized body makes a decision to start registration. Further, the authorized body (expert organization) of the reference state, within 45 working days from the date of its decision to start the procedures for registration and examination of the medical device, draws up an expert opinion and sends it for approval to the authorized bodies of the receiving states.
A separate procedure, in case of insufficient information in the expert opinion, may be the inspection of production by checking all processes and stages of production of a medical device.
It is important to note that the registration of a medical device depends on the approval of the expert opinion by all receiving states. At the same time, the authorized body of the reference state has the right, in case of failure to resolve disagreements on the issue of agreeing on an expert opinion, to send a notification to the applicant about the need to agree on an appeal to the Advisory Committee to resolve disagreements.
Thus, the procedure for the state registration of a medical device according to the rules of the EAEU allows its circulation in several EAEU member states, but at the same time it requires detailed preparation of all documents necessary for registration and examination of a medical device, as well as, if necessary, preparation for the inspection of production. In particular, for these purposes, the registration dossier is prepared and all necessary tests and studies are carried out.
- Advising on all issues of registration of a medical device in accordance with the rules of the EAEU
- Legal assistance in the preparation of an application for registration of a medical device in the EAEU
- Legal advice on the preparation of the registration dossier
- Legal support for testing and clinical trials of a medical device
- Legal assistance in interaction with authorized bodies (expert organizations) of the reference state and / or authorized bodies of the receiving states
- Legal support in the formation of a package of documents for submission to the authorized body of the reference state in order to register a medical device
- Monitoring of changes in the legal acts of the EAEU regulating the issues of registration of medical devices