UDI updates from FDA

New guidance from the US Food and Drug Administration lays out key components of Unique Device Identifier (UDI) form and content that medical device manufacturers should incorporate into their compliance efforts. In the guidance document (provided by the following...
MEDDEV 2.7/1 Rev 4

MEDDEV 2.7/1 Rev 4

Following the release of MEDDEV 2.7/1 Rev 4 with updated guidance on clinical evaluations in Europe, Methodize takes a closer look into some of the new version’s recommendations and their impacts on medical device manufacturers. Latest revision In June 2016 Revision 4...

UDI REQUIREMENTS IN THE EUInline image

As the United States expands the scope of the FDA Unique Device Identification (UDI) system to include additional medical devices classes, other countries are moving forward to create similar UDI systems to better identify medical devices from the manufacturer,...