The Eurasian Economic Commission's Board has amended the Rules for classifying medical products depending on the potential risk of use. According to these amendments, antiseptic wipes for cleaning the hands of medical personnel, operating and injection fields will now be classified as risk class 2a.
Medical products containing substances which, when used on their own, may be considered as medicines, are classified in the third class of risk in the current version of the Rules. This rule was also applied to ethyl alcohol wipes. But since in this case ethyl alcohol only performs the antiseptic function, respectively, there are no risks that exist when using medical products with medicines.
Therefore, the EEC Board decided to reduce the risk class for medical antiseptic wipes. This will help reduce the administrative burden on manufacturers of such products, given the risk-based approach.
The classification of medical products depending on the potential risk of use affects the list and content of documents required for the registration of medical products under the Union's rules and safety surveillance measures during the post-registration period. The higher the risk class of a medical product, the higher the requirements.
