CE marking
2020-03-18
GAP Analysis: EU MDR Compliance
This article provides a general overview of what a gap analysis is in the context of the Medical Device Regulation (MDR) 2017/745.
CE marking
2020-03-17
CE Marking Medical Device Standalone Software – MDR & IVDR Guide
The article provides a general overview of the medical device regulatory process for manufacturers, as well as additional guidance specifically relevant to standalone software.
CE marking
2020-03-08
Medical Device Classification According to the MDR
Manufacturers who want to place their medical devices on the European market must refer to the Medical Device Regulation (MDR) 2017/745 to determine the appropriate risk class of their devices.