Sonoma Pharmaceuticals (SNOA) has completed transition to the new European Union Medical Device Regulation for four of its products in Europe. Sonoma was granted classification as a Class IIb medical device for Microdacyn60 Wound Care and Microdacyn60 Hydrogel, its scar gel product Epicyn, and Pediacyn for atopic dermatitis. The MDR was adopted in the EU in 2017 to replace the existing Medical Device Directive. The transition period for compliance was most recently extended to December 31, 2028 for non-implantable Class IIb and lower risk devices. In order to comply with the MDR, Sonoma’s products needed to meet certain requirements relating to safety and performance and successfully undergo verification of regulatory compliance, or conformity assessment.
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