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 gynecological device FT.CE.110 marks a crucial milestone and underscores our commitment to excellence and women’s health.
A Safety Milestone for a Class IIb Gynecologic Device (FT.CE.110)
The certified device is a vaginal suppository indicated for the prevention and treatment of non-specific vaginal dryness and atrophic vaginitis. It is an adjunct in cases of irritation, burning, and discharge, and supports care in inflammatory or infectious vaginal conditions. The product is compatible with condoms.
Being a Class IIb medical device entails a rigorous conformity assessment that assures compliance with the General Safety and Performance Requirements (GSPR) in Annex I of the MDR.
Key Components and Functional Rationale
- Hyaluronic Acid & Triglycerides – Provide hydration and lubrication of the vaginal mucosa, helping to relieve burning and restore comfort.
- Lactic Acid (pH 3.5) – Rapidly reduces vaginal pH, helping to re-establish the natural defenses (vaginal flora).
- Polycarbophil & Vitamin E, among other excipients – Selected and assessed to support mucoadhesion, barrier function and antioxidant protection.
All ingredients have undergone a rigorous evaluation to ensure safety and performance consistent with the intended use.
The MDR Conformity Pathway: What We Implemented
Achieving MDR compliance requires a structured, end-to-end program under an ISO 13485-compliant Quality Management System (QMS), including:
- Risk Management – Comprehensive analysis according to UNI CEI EN ISO 14971, identifying and mitigating risks across the full lifecycle.
- Biocompatibility – Targeted testing (direct-contact cytotoxicity, delayed-type hypersensitivity, etc.) under UNI EN ISO 10993 standards.
- Clinical Evaluation – A complete Clinical Evaluation Report consistent with MEDDEV 2.7/1 rev.4, demonstrating performance and safety aligned to the intended use.
- Stability & Compatibility – Long-term stability studies following ICH guidance; condom compatibility demonstrated per EN ISO 4074.
The outcome is a reliable, well-tolerated, “woman-friendly” solution, suitable for women of reproductive age, perimenopause, and menopause.
Why MDR Certification Matters
- Higher Quality Standards – MDR enforces elevated safety and performance thresholds—vital for devices restoring vaginal microflora and helping reduce infection risk.
- Traceability & Post-Market Surveillance – Stronger UDI-based traceability supports efficient vigilance and rapid field actions if needed.
- Credibility & Market Trust – Certification strengthens our position as a manufacturer delivering devices backed by clinical evidence and robust risk management.
Partner With Us for Fast, Low-Risk Market Entry
Distribute our MDR-certified Class IIb Vaginal Suppository (FT.CE.110) for rapid market deployment with maximum regulatory confidence. As certified manufacturers of Medical Devices, Dietary Supplements and Dermocosmetics, we offer ready-to-market or high-margin private label options—complete with regulatory and clinical support—to scale your portfolio efficiently.
