2 days ago
Poriferous, LLC Achieves Coveted EU MDR Regulatory Certification for Porous Polyethylene Implants
Newnan, GA August 18, 2025 --( )-- Poriferous LLC., industry innovator in high density porous polyethylene craniomaxillofaical implants, announces it has successfully received its EU Medical Device Regulation (MDR) certification. This regulatory authorization has been achieved by only 15% of medical device companies, putting Poriferous and their SU-POR® line of products in esteemed company. The certification testifies to Poriferous' rigorous standards for safety and quality, ensuring their devices have no negative impacts on human health.
The EU MDR replaces the former Medical Device Directive (MDD) and establishes a more intensive and transparent regulatory framework with greater long-term viability. It emphasizes post-market surveillance, implements Unique Device Identifications (UDIs) to track devices in the supply chain, and specifically includes devices that may not have a strictly medical function, such as implants used in cosmetic surgeries. Because of these additions to the regulatory standards, Poriferous' SU-POR Implants are now included in this new, enhanced system for regulatory quality.
The MDR certification covers the entire Poriferous catalogue of SU-POR Implants, reaffirming Poriferous' mission of providing quality healthcare and innovation to surgeons and patients around the world.
Contact Information:
Poriferous, LLC
Krista Bradstreet
470-699-8608
Contact via Email
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