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What do Guinness and UDI Have in Common? Both are in Ireland, of course...

by Jay Crowley

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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 European regulations of devices – e.g., Norway, Liechtenstein, Iceland, Turkey and Switzerland) is the transition to the new medical device regulations (the MDR and IVDR) – and ALL the many changes that this entails. This should be a great opportunity to share understanding and progress to date.

One of the more interesting and complex challenges for device manufacturers implementing the MDR/IVDR (especially those that are not physically located in Continental Europe) are the new requirements for economic operator involved in the distribution of their medical devices. The MDR/IVDR places very specific obligations on distributors and importers to ensure that the devices that they place on the EU market on behalf of a device manufacturer are compliant with the regulations and that any issues are addressed as quickly and effectively as possible. And of course, the way that we tie all the devices and economic operators together is through UDI. This increased scrutiny and clearly identified roles and responsibilities will provide more transparency and help secure the supply chain.

Specifically, the regulations require that importers and distributors verify, before distributing a device, that the manufacturer has properly assigned a UDI to the device. This also includes assuring that the UDI is in compliance with the rules of the chosen issuing agency. This applies not just to the device/label UDI – but to the UDIs on various higher levels of packaging as well. And though not specifically stated, it would seem that UDI assignment in a vacuum is of little use – so the UDI must be properly represented in the UDI carrier (AIDC and HRI) and the product master data submitted to Eudamed’s UDI Database must be valid and up to date. Moreover, when an importer or distributor believes that a device is not in conformance with the regulations, they must NOT place the device on the market until it has been brought into conformance – and must inform the manufacturer (or their authorized representative). And, if the importer or distributor believes that the device may presents a serious risk or is a falsified device – then they must also inform the relevant competent authority. A lot of new responsibilities for importer or distributor that will obviously require more and better communication between and among the various parties…

 

 

About the Author

Jay Crowley 6Jay 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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