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European Medical Device Directives – How a small-medium sized medical device company responded to the new regulations

Susan Gosnell Life Sciences Leave a Comment

The medical device directives are currently being revised by the EU’s institutions in a process that began in 2008. This revision has the following objectives: To ensure a consistently high level of health and safety protection for EU citizens using these products To maintain the free and fair trade of the products throughout the EU To adapt legislation to the …

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Helpful resource in planning for September UDI deadline for Class II device compliance

Susan Gosnell Life Sciences Leave a Comment

Manufacturers of Class II medical devices must comply with the FDA’s Unique Device Identifier (UDI) regulations by September 2016, the latest in a series of deadlines for varying devices. Are you ready? The FDA manages a Global Unique Device Identifier Database (GUDID), to which manufacturers must submit their device details, via one of three accredited agencies. There is a fair …

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Who bears responsibility for submitting UDI data to the GUDID?

Reed Tech Life Sciences Leave a Comment

The FDA has specified in its Final Rule on Unique Device Identification (UDI) that medical device labelers marketing their products in the United States are required to submit data records to its Global Unique Device Identifier Database (GUDID, pronounced “Good-ID”). The next question to ask is which company (or companies) involved in bringing a particular device to market qualifies as …

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Highlights from the UDI Conference 2016 and Medical Device and Diagnostic Labeling Conference

Susan Gosnell Life Sciences Leave a Comment

In late April I attended a couple of medical device industry conferences which were both eye-opening in different ways. The looming issue of UDI compliance was at the heart of both conferences, though they took contrasting approaches. UDI Conference 2016, Baltimore MD, April 18-19 This was an official FDA-sponsored event, where a large number of delegates from medical device manufacturers, …