iRhythm Technologies Receives European Union s CE Marking Under Medical Device Regulation (EU MDR) for its Zio® monitor and ZEUS System sina.com.hk - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from sina.com.hk Daily Mail and Mail on Sunday newspapers.
Regulation of medical devices is always a messy and complicated task, but that has proven to be particularly true of the European Union’s (EU) Medical Device Regulation (MDR). Thanks largely to problems with the capacity of notified bodies (NBs) to review renewals of existing CE marks, patients in the EU may experience a significant dearth of medical devices over the next couple of years, a nightmare scenario that has all stakeholders scrambling for solutions.
JUNE Medical is proud to announce that its Galaxy II® self-retaining surgical retractor has received Medical Device Regulation (MDR – Regulation (EU) 2017/745) certification from BSI Group for its use in the European Union.
Loeb & Loeb’s Melanie Howard and Kristen Klesh discuss AI Pins, how they may be redefining wearables tech as a luxury fashion accessory and whether they might be subject to regulation in the United States as medical devices.