Changes to the rules for the registration and safety examination of medical devices have come into effect in the EAEU.

• Clinical trials are now mandatory even for low-risk devices (classes 1 and 2a), which was not previously required.


• If a specific type of device is not included in the nomenclature of the EAEU, the reference authority must initiate its inclusion and notify the applicant.


• Terminology is now aligned with international standards (IMDRF): the term "accidents" is replaced with "adverse events (incidents)."


• Wording has become more precise and modern; for example, the terms "models (brands)," "by applicability," and "processing" have been clarified.

EEC Decision No. 50