Agfa Radiology Solutions achieves EU MDR certification for its entire DR portfolio

Agfa Radiology Solutions announces that it has completed the transition of all of its direct radiography (DR) X-ray rooms, mobiles and retrofits to the European Union (EU) Medical Device Regulation 2017/745 (MDR).

Agfa was an early adopter, achieving Quality Management System certification according to the MDR for its DR 400 room in 2022. Agfa has now extended the certification to its entire DR portfolio.

“In March 2023, the EU extended the transition period for the MDR. However, with our commitment to quality enhancement and system improvement, we chose to continue our ambitious and demanding roadmap. As an early adopter, we were ideally positioned to achieve the transition well within the original timeframe. We are very proud that our entire portfolio of DR X-ray rooms, mobiles and retrofits has now been certified as meeting the enhanced requirements of the regulation – considerably in advance of the new deadline. This portfolio will be showcased at ECR 2024, both at our booth and via our digital platform, so we welcome ECR visitors to stop by and learn more,” says John Gibbs, QARA Manager EMEA of Agfa Radiology Solutions.

Find out more about the Agfa DR portfolio and its EU MDR certification at our ECR booth: Vienna, February 28-March 3, Expo Hall X2, booth #207

Read the full press release here