By Order No. 130 of August 18, 2026, the Board of the Eurasian Economic Commission approved a draft resolution of the EEC Council amending paragraph 114 of the Rules for the Registration and Examination of Medical Devices. The document was submitted to the Council of the Union for consideration. The order entered into force upon publication on the official EAEU website—August 20, 2026.
The essence of the changes
It is proposed to supplement paragraph 114 of the Rules, approved by Decision of the EEC Council dated February 12, 2016 No. 46, with a new subparagraph “g”, which introduces an additional basis for suspending the validity of a registration certificate.
The mechanism of innovation
— The basis for suspension is the absence of a valid report on the results of the production inspection in the registration dossier.
— Exceptions — the rule does not apply to medical devices of potential risk class 1 and non-sterile devices of class 2a.
— Protective mechanism: If an application for a scheduled inspection is submitted within the established deadline (in accordance with paragraph 2, clause 35 of the QMS Requirements), and the authorized body of the reference state is notified of this, along with copies of the application and the agreement with the inspecting organization, suspension is not applied automatically. In this case, suspension is possible no earlier than 25 working days after the expiration of the previous inspection report.
Who is affected by the changes?
The changes affect manufacturers and holders of registration certificates for medical devices circulating within the EAEU, as well as authorized bodies of member states responsible for organizing inspection control.
Dates of entry into force
Once adopted by the EEC Council, the decision will enter into force 30 calendar days after its official publication. The draft is currently undergoing interstate approval.
