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.