Your Prescription for Compliance Health • 855-324-6279

Update – Extension for the new EU MDR transition period

The European Union (EU) is bringing significant changes to their regulations related to medical devices and in vitro diagnostic devices. The new medical device regulations (MDR) and in vitro diagnostic device regulations (IVDR) represent a huge overhaul of the current certification process. ECI-Rx’s Brijesh Patel highlights the important changes that will affect manufacturers.

Read more

Preparing for the new EU Medical Device Regulations

The European Union (EU) is bringing significant changes to their regulations related to medical devices and in vitro diagnostic devices. The new medical device regulations (MDR) and in vitro diagnostic device regulations (IVDR) represent a huge overhaul of the current certification process. ECI-Rx’s Brijesh Patel highlights the important changes that will affect manufacturers.

Read more