Elekta has received the EU Medical Device Regulation (EU MDR) certificate for its linear accelerator (linac) portfolio.
The MDR certificate applies to the following products, including their components and accessories: Versa HD, Elekta Synergy and Elekta Infinity.
The EU MDR will become effective May 2021
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.
“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,” says Anders Skoglund, Elekta’s Vice President Regulatory Affairs & Quality.
The 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).
Photo: Elekta Versa HD