Redsense obtains MDR registration on what would have been the regulation’s first day of application
On 26 May 2020, the same day as the original date of application of the EU’s new Medical Device Regulation (MDR), Redsense Medical became one of the first companies to achieve compliance with the new regulations as the Company obtained its confirmation of registration.
The revised legal framework for medical devices in the EU was adopted in 2017, and was originally intended to enter into force on 26 May 2020 after a transitional period. The date of mandatory application was recently postponed one year due to the COVID-19 crisis to relieve the pressure on affected parties, and the rules will now apply from 26 May 2021 for any company marketing such products in one of the European Community countries.
“The new regulations contain a series of modernizations and reinforcements to improve transparency and safety, and this is something that every actor on the medical device market, from their manufacture to their use, are affected by and will have to comply with to pursue their activities. By obtaining this registration now, despite the postponement of the application date, we stay one year ahead of the regulatory requirements and demonstrate that we are willing and able to lead the way towards enhanced patient safety and more modern and robust practices,” says Patrik Byhmer, CEO of Redsense Medical AB.
For more information, please contact:
Patrik Byhmer, CEO Redsense Medical AB (publ)
Phone: +46 35 10 60 30
ABOUT REDSENSE MEDICAL
Redsense Medical is a corporate group with operations mainly in Europe and the United States. The company has developed the Redsense System, an innovationused for monitoring and alarm in the case of blood leakage in connection with a hemodialysis treatment. Redsense Medical solves one of the most serious remaining safety problems within hemodialysis – to quickly detect Venous Needle Dislodgement and catheter leakage to minimize blood leakage. The system consists of a patented fiber optic sensor, designed for either venous needle or central venous catheter, which is connected to an alarm unit. From the very start, the development of the company's technology has been based on the demands and safety requirements of healthcare providers in the dialysis sector.