The key changes that were implemented:
- Stricter requirements for clinical trials have been introduced, which are now mandatory for risk class 1 and 2a devices, whereas previously there were exceptions for them.
- A clear procedure has been established for cases where the type of device is not listed in the nomenclature of the EAEU — the reference authority is required to initiate the process of its inclusion and notify the applicant.
- Terminology has now been harmonized with international standards (IMDRF): the term "accidents" has been replaced with "adverse events (incidents)."
- Formulations such as "models (brands)", "by applicability", and "processing" have been clarified, making the text more modern and precise.
The EEC Decision No. 50, adopted on July 8, 2025, became effective on February 24, 2026.
EEC Decision "On Amendments to the Rules for Registration and Examination of the Safety, Quality, and Effectiveness of Medical Devices"
EEC Decision No. 50
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