Agfa achieves EU MDR certification for direct radiography portfolio

Agfa Rsna 2019 400 (2)

Agfa Radiology Solutions has completed the transition of all of its direct radiography x-ray rooms, mobiles, and retrofits to the EU Medical Device Regulation (MDR) 2017/745.

Agfa was an early adopter and achieved Quality Management System certification according to the MDR for its direct radiography 400 room in 2022. Agfa has now extended the certification to its entire direct radiography portfolio. The MDR aims to provide patients with access to safer, more effective, and technologically advanced medical devices. It introduces stricter requirements for manufacturers, importers, and distributors, Agfa said.

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