Elekta 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:
The EU MDR, ratified in May 2017, will become effective in May 2021, followed by a transition period until May 2024. Its purpose is to ensure that medical devices are introduced to and sold on the market within a robust, transparent and sustainable regulatory framework.
Anders Skoglund, Elekta's Vice President Regulatory Affairs & Quality, says: “Elekta believes that the MDR provides a good framework for ensuring that the wellbeing of patients is at the forefront of healthcare in Europe and the rest of the world. We are happy that our stringent attention to patient safety meets or exceeds the criteria for this regulation. Attaining MDR certification has been a challenge for all stakeholders, both at the EU level and for the medical device industry, but Elekta has overcome these challenges every step of the way.”
Maurits Wolleswinkel, President Linac Solutions at Elekta, adds: “As a leading medical device company, we’re proud that Elekta is among the first to guarantee that its customers will be able to continue offering their patients advanced cancer treatment without interruption. More importantly, it supports Elekta’s promise to make quality radiation therapy accessible to all, especially during the Covid-19 pandemic.”
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).Back To Top
Elekta Secures EU MDR Certificates for Linac Portfolio. Appl Rad Oncol.