News

01.01.1970 (Обновлено: 25.05.2023 09:23)

Rules for classification of medical products depending on potential risk of use updated

The Eurasian Economic Commission's Board adopted amendments to the Rules for the classification of medical products depending on the potential risk of use, approved by Decision No. 173 of the EEC Board dated December 22, 2015 .

The classification of medical products is aimed at ensuring the application of a risk-based approach in regulating their circulation. The amended version of the Rules takes into account the law enforcement practice and changes in the documents of the International Medical Device Regulators' Forum (IMDRF) in relation to software that is a medical product and in vitro diagnostic medical devices.

Therefore, the classification of medical devices will take into account the approaches currently adopted in the international practice, which will improve the availability of medical products in the Eurasian Economic Union countries, as well as the export potential of their manufacturers. Besides, Decisions No. 116 and No. 123 of the EEC Board dated July 24, 2018 on differentiating the elements of medical products and the criteria for including several modifications of a medical product in a single registration certificate were declared invalid.