Gruppo FarmaImpresa at the Top of European Quality: Maximum Safety for Gynecologic Well-Being The EU Regulation 2017/745 (MDR) is Europe’s most stringent framework for manufacturing and marketing medical devices. It raises the bar on safety, quality, and traceability, introducing far stricter requirements than previous directives. For Gruppo FarmaImpresa, obtaining MDR certification for the Class IIb…
MDD Certified Vaginal Tablets for Intimate Health The Medical Device Regulation (MDR), in effect since May 2017 and fully applicable from May 2021, regulates medical devices in Europe. Thanks to deadline extensions, devices compliant with the MDD Directive can continue to be marketed until December 31, 2027, for Class III and implantable Class IIb devices,…
Vaginal Gel: Registered Medical Device in UK for Women’s Intimate Well-Being We are pleased to announce the official registration with the relevant authorities in the UK of a Class II medical device, compliant with MDD regulations. This is a vaginal gel with a pH of 4.5, packaged in practical 5 ml tubes (6 tubes per…