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

• Mandatory clinical trials now apply to all devices, including those classified as risk 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 is obliged to initiate its inclusion and notify the applicant.


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


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

EEC Decision No. 50