MDR-Certified Vaginal Suppository: Women’s Health Milestone

News, Regulatory

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…

GFI Extends MDD Certificate for GERD Devices

News, Products

Extension of MDD Certificate for Our Medical Devices for the Treatment of Gastroesophageal Reflux Disease (GERD) Based on Alginates The MDR regulation, effective from May 2017 and applicable from May 2021, governs medical devices in Europe. Deadline extensions allow the marketing of devices compliant with the Medical Devices Directive (MDD) until December 31, 2027, for…