Elekta early out in securing MDR certificates for its linac portfolio
Compliance with regulations benefits hospitals and patients by securing market access and avoiding disruption of product deliveriesSTOCKHOLM, September 25, 2020 – Elekta (EKTA-B.ST) announced today it has received the EU Medical Device Regulation (EU MDR) certificate for its flagship linear accelerator (linac) portfolio. More than 4,000 Elekta linacs are currently clinical around the world, treating patients with a wide variety of cancers. The MDR certificate applies to the following products, including their components and accessories: · Versa HD™ · Elekta Synergy® · Elekta