EUDAMED Implementation and Roll-Out Timeline Update

EUDAMED Implementation and Roll-Out Timeline Update

The European Commission recently sent out an update on the plan for implementation and roll-out of EUDAMED, as it stands today. Changes to the implementation timeline of different modules, and how they will affect the application of each aspect of MDR are outlined...
UDI Submission for China NMPA

UDI Submission for China NMPA

Although the regulatory process can be challenging due to rapid changes, bringing medical devices to the Chinese market is a potential high-growth area for many global manufacturers.  So, if you’re a medical device manufacturer doing business in China, it’s important...
FDA Delays UDI Deadline for Class I Devices to September 2022

FDA Delays UDI Deadline for Class I Devices to September 2022

The US Food and Drug Administration (FDA) has released new guidance regarding Unique Device Identification (UDI) compliance dates for Class I and unclassified medical devices.  Effective immediately, the FDA has postponed GUDID (Global UDI Database) compliance for...