Compliance with regulations benefits hospitals and patients by securing market access and avoiding disruption of product deliveries
STOCKHOLM, 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 Infinity™
The EU MDR, ratified in
Elekta will continue its certification program to ensure that its advanced precision radiation medicine portfolio will be fully compliant during the MDR transition period.
About Medical Device Regulation
The Medical Devices Regulation 2017/745/EU (MDR) brings EU legislation into line with technical advances, changes in medical science and progress in law making. The EU-MDR is designed to be more stringent than the previous Medical Devices Directives (MDD).
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For further information, please contact:
Tel: +46 70 865 8012, e-mail: Mattias.Thorsson@elekta.com
Time zone: CET: Central European Time
Tel: +1 770-670-2524, e-mail: raven.canzeri@elekta.com
ime zone: ET: Eastern Time
About Elekta
For almost five decades, Elekta has been a leader in precision radiation medicine. Our more than 4,000 employees worldwide are committed to ensuring everyone in the world with cancer has access to - and benefits from - more precise, personalized radiotherapy treatments. Headquartered in
https://news.cision.com/elekta/r/elekta-early-out-in-securing-mdr-certificates-for-its-linac-portfolio,c3202756
https://mb.cision.com/Main/35/3202756/1310600.pdf
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