[FEATURED] FDA To Makers Of EUA Devices: Don’t Forget To Report Adverse Events
Manufacturers of devices granted emergency use authorization (EUA) status during the COVID-19 crisis are fully responsible for filing any adverse events about the products to the FDA, the US agency […]
The Deadline for Compliance with MDR 2017/745 is Extended to 26 May 2021: Changing and Challenging Dynamics
Author: Suzanne Broussard The global COVID-19 pandemic prompted the 1-year extension of the Medical Device Regulation (MDR) 2017-745 date of application. The delay is creating a changing and challenging dynamic landscape for device manufacturers and notified bodies (NBs). […]
[FEATURED] EU COVID-19 Response: Who Is Leading EU’s Decision-Making For Medtech?
The COVID-19 pandemic has meant seismic shifts in the way the EU has been operating to regulate and procure emergency equipment needed on the frontline. Unprecedented changes have been required, […]
