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 […]
The European Commission Pledges Make the Different Eudamed Modules Available On A Rolling Basis
Author: Dr. Suzanne Broussard One of the recent announcements in the everchanging medtech sector is that the newest European database on medical devices (Eudamed 3) will roll out modules as they become functional. Eudamed 3 is the cornerstone for the new medical device regulations (MDR) and […]
In Vitro Diagnostic Devices Require Extensive Analytical and Clinical Technical Documentation for IVDR 2017/746 Compliance
Author: Dr. Suzanne Broussard The In Vitro Diagnostic Device Regulation (IVDR) 2017/746 is making sweeping changes to the European Union regulatory requirements for in vitro diagnostic (IVD) devices. The expanded Technical Documents requirements and the need for a life cycle approach […]
