EUDAMED and GUDID – What’s Changed?

EUDAMED and GUDID – What’s Changed?

The European Database for Medical Devices (EUDAMED) EU-MDR, the European Union’s Medical Device Regulation is intended to support both pre-market product registration processes and post-market surveillance & vigilance activities by national regulators across the...
UDI Compliance: The Key Dates

UDI Compliance: The Key Dates

In 2013 the Food and Drug Administration issued a final rule setting out a system for Unique Device Identifiers, or UDIs, that should be applied to medical devices. These UDIs must be in both plain text and a format that can be read by a machine, such as a bar-code....