MDD or MDR? Medical Device Manufacturers Are Faced with a Big Decision Going Forward Under the MDR Extension
Author: Suzanne Broussard | August 24, 2020 The passing of the delay for the Medical Device Regulation (MDR) date of application to May 26, 2021 was welcoming news for many device manufacturers. However, the delay now has manufacturers […]
Software Can Be An In Vitro Diagnostic Device Under IVDR 2017/746
Author: Dr. Suzanne Broussard | August 18, 2020 Software is now considered a medical device if that is its intended purpose according to the European Union’s definition of in vitro diagnostic (IVD) devices in the new In Vitro […]
The Second Corrigendum of Medical Device Regulation (MDR) 2017/745 Offers Manufacturers a 4-Year the Grace Period for Eligible Class I Medical Devices
Author: Dr. Suzanne Broussard | August 10, 2020 The European Parliament adopted a Second Corrigendum of MDR 2017/745 to address the serious possibility for shortages of reusable class I medical devices under the […]
