We are rapidly approaching the 5-year anniversary of the publication of the US Unique Device Identification (UDI) regulation – which itself was the culmination of nearly ten years of work by a large, dedicated group of us who believed in UDI’s ability to positively transform the entire medical device ecosystem.  At the same time, we also developed the Global Harmonization Task Force (GHTF) – and then International Medical Device Regulators Forum (IMDRF) – UDI Guidance Document in the hopes of fostering a globally harmonized approach to UDI.  And now we are seeing the next steps – as other regulators, purchasers, and device users continue the work – and push UDI adoption and implementation for a whole host of use cases both in the US and (maybe more importantly) globally. All of this, of course, brings new challenges – and new opportunities.

One of the very critical and foundational elements that I believe led to the successful development and publication of the US UDI regulation – and the GHTF/IMDRF Guidance Documents – was the very public and open (and lengthy) conversation (and debates) we ALL had about the goals, purposes, issues, and concerns association with UDI.  These conversations and debates took many forms and occurred in many forums – but consistently one of the most critical and useful forums was – and is – the annual UDI Conference – now in its 10th year! It was and is an opportunity for all of us to meet, check-in, and understand what is happening, what issues and problems are people having – and what work is still left to do.

As in years past – this year’s conference will focus on current implementation and adoption issues – both within the US and globally, and there is a lot occurring in both. I encourage you to attend – and look forward to continuing the conversations. I will be hosting 2 sessions on Tuesday, April 24th on global activities: the first session will focus on the many global UDI activities – with a focus on the EU MDR/IVDR UDI requirements; the second session will look more broadly at the MDR and IVDR regulations, and the activities that you need to be doing today to meet the May 2020 compliance deadlines. 

To make it easier for you to attend, we are offering $200 off of the registration rate – enter “USDM” in the discount field to redeem. Register today by clicking here. You can also RSVP for our Happy Hour on April 24th for a chance to network after the first day of the conference. I look forward to seeing you all in Baltimore (my home town!) at the end of the month…

Take care - Jay

 

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About the Author

Jay Crowley is the Vice President of the UDI Services and Solutions at USDM Life Sciences. Jay was most recently Senior Advisor for Patient Safety in the Food and Drug Administration’s Center for Devices and Radiological Health. Jay developed the framework and authored key requirements for FDA’s Unique Device Identification system.

About USDM Life Sciences

USDM Life Sciences is a global life science and healthcare services company, providing strategy and compliant technology solutions to regulated industries. If you work in Life Sciences or Healthcare, partnering with USDM Life Sciences makes it easy to accelerate innovation and maximize productivity. USDM Life Sciences only focuses on regulated industries and has built trusted partnerships with the most innovative technology companies in the world, and boast a staff of industry leading experts in the areas of technology and compliance.

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