MedTech article - May 26, 2021
May 26 2021: The EU MDR Deadline
Today, on 26 May 2021, the Medical Device Regulation (MDR) will become fully applicable, following the transition period. What does this mean and what do medical device companies and others need to consider? In May 2021 the Medical Device Directive (MDD) and the Active Implantable Medical Devices (AIMD) will be replaced by the Medical Device […]
MedTech article - January 22, 2021
Are you ready for MDR?
In May 2021 the Medical Device Directive (MDD) and the Active Implantable Medical Devices (AIMD) will be replaced by the Medical Device Regulation (MDR) in the EU. What does this mean and what do medical device companies and others need to consider? The reason behind the new medical devices regulation (2017/745/EU), MDR, is to bring […]
MedTech Business - September 28, 2020
Elekta secures MDR certificates for its linac portfolio
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 […]
