The Medical Device Regulation (MDR) and In Vitro Device Regulation (IVDR) Mandate that Device Manufacturers Have a Person Responsible for Regulatory Compliance (PRRC): Guidelines and Support
Author: Suzanne Broussard | September 07, 2020 The newly created Person Responsible for Regulatory Compliance (PRRC) position is a unique regulatory requirement that applies only to the European Union, and is a key area of responsibility for a person […]
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 […]
