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UDI Blog
by Jay Crowley Join Jay at the MDR & IVDR EU Conference, December 4-6 in Orlando, Florida! On 5 April 2017, the European Medical Device (MDR) and In Vitro Diagnostic Medical Device (IVDR) Regulations were published in the Official Journal of the European Union – the last step in their long and arduous journey. The MDR applies from 26 May 2020 and the IVDR applies from 26 May 2022. These new regulations were developed because “… a fundamental revision of those Directives [on medical devices, active implantable medical devices, and in vitro diagnostic medical devices] is needed to establish…
by Jay Crowley We are excited to be at the Medtec Ireland conference in Galway this week. As an Irish descendant and a Guinness aficionado – I always enjoy my trips to the Emerald Isle. Ireland is home to many medical device manufacturers (8 of the world’s 10 largest medical device companies are located in Ireland – and 18 of the top 25 devices companies have a base in Ireland) and a good deal of sophisticated manufacturing of devices that are distributed globally. And of course, the big topic for EU countries (as well as those countries that leverage the…
by Jay Crowley Over the past 15 years, I have been fortunate enough to travel around the globe discussing and developing Unique Device Identification (UDI). I am always struck by how similar – and yet interestingly different – people, societies, and countries (as well as the regulation of medical devices) are around the world. Nowhere is this truer than in China. Though the people of China are similar in many ways, there is so much that is different. There are differences in the language (both written and spoken), the food, the culture, the politics, and the “eastern”…
by Jay Crowley As I mentioned in my last post, I believe our goal of a “globally harmonized” approach to UDI appears to be on a path to relative success. Though not our intent in developing the Global Harmonization Task Force (GHTF) and International Medical Device Regulators Forum (IMDRF) UDI guidance documents, the majority of the EU Medical Device Regulations (MDR)/In Vitro Diagnostic Regulations (IVDR) UDI System requirements are literally copied and pasted from the IMDRF guidance document (please send an email to usdm@usdm.com if you would like a copy of the comparison). More importantly, other regulators…
by Jay Crowley As I mentioned in my last post, we were focused not only on developing a US UDI System, but maybe more importantly on a globally harmonized approach to UDI. There were a number of reasons for this; the first, and hopefully obvious one, is that a global UDI would allow all to have visibility across the global supply chain and be better able to share data among regulators about the safe and effective use of devices and, for example, be able to identify problems more quickly or address recalls across borders. Moreover, the device…
by Jay Crowley It is hard to imagine that, what I started in 2002 as an idea to better identify the specific medical devices potentially involved in adverse events, has – over the past nearly 15 years – become the globally recognized and accepted concept of Unique Device Identification – or UDI. The term and concept did not exist before this point. There were of course other concerns to address – the better identification of devices subject to a recall, availability of devices for public health emergency response, supporting anti-counterfeiting efforts, and the need to identify devices specifically in the emerging…
At some point in the future when a product is no longer distributed, the medical device company will need to put a commercial distribution end date into the Global UDI Database (GUDID).  The product’s data will still reside in the database, but a flag will be set to let people know this product is no longer in distribution.  The product may still be in the supply chain and people may still own it, but medical device companies are required to add a date of when the product is no longer being distributed. USDM Life Sciences will help you assess, plan and…
A convenience kit is one or more devices put together for the convenience of the user. An example of a convenience kit would be a suture removal kit. The FDA has published draft guidance that further clarifies the definition of convenience kit to limit it to those situations where everything is kept together. A configurable system is multiple devices that come together to create multiple pieces of a system that come together to create a finished product. A configurable system, has one or more available components or subsystems that a user can choose. The components come together at the point…