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| ![]() Poriferous, LLC Achieves Coveted EU MDR Regulatory Certification for Porous Polyethylene ImplantsThis achievement marks a major milestone for Georgia company as they continue their mission to provide quality healthcare at the highest level.
By: Poriferous, LLC 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. End
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