Clinically tested medical device for vaginal dryness, altered pH, and intimate discomfort Vaginal dryness and altered vaginal pH are common issues affecting women of all ages, particularly during menopause, postpartum, or periods of physical and emotional stress. Typical symptoms include burning, itching, pain during intercourse, irritation, abnormal discharge, and emotional or sexual distress that can…
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…
An Overlooked Issue: Sexual Dysfunction in Menopause Menopause is a time of profound physical, hormonal, and emotional changes in a woman’s life. One of the most common—but often neglected—consequences is sexual dysfunction, which can include reduced desire, vaginal dryness, pain during intercourse, difficulty with arousal, and trouble reaching orgasm. According to some estimates, up to…
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 Suppository with Boric Acid for Intimate Well-Being We are pleased to announce the recent registration of our vaginal suppository with the Ministry of Health and Prevention of the United Arab Emirates. Formulated as a medical device, it provides restoration of protection, hydration, and pH balance. Its triple antibacterial, antifungal, and antimicrobial action helps prevent…
MDD Certification for Our Vaginal Ovules: A New Milestone for Intimate Health The MDR Regulation, in force since May 2017 and applicable from May 2021, governs European medical devices. Deadline extensions allow medical devices compliant with the Medical Device Directive (MDD) to be marketed until December 31, 2027, for Class III and implantable Class IIb…
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…