English to Russian Medical Medical: Pharmaceuticals исследование

although the formulation contains boric acid which has been classified as GHS Category 1B (presumed human reproductive toxicant) at a level above the EU MDR limit of 0.1% in a medical device product (EU Medical Device Regulation, Annex I; May 2017), a comprehensive assessment has been conducted and, based on the low actual exposure to the patient, concluded that the benefits of including boric acid in the formulation far outweigh the negligible risks