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As a medical device manufacturer, you are required to create and maintain a Unique Device Identification (UDI) system for each medical device in each market that requires it. A unique device identification system necessitates the label of devices to bear a series of characters that consists of a unique identifier (DI) and production information (PI), created through internationally accepted device identification and coding standards, allowing explicit identification and transparency of specific devices on the market.
While the UDI is developed per the issuing agencies’ respective guidelines, it’s on you as the manufacturer to submit the identifier and product data attributes to comply with each regulatory body’s requirements. The problem is, UDIs are handled differently by different agencies. For example, in the US, a UDI is required for all medical devices, except non-prescription retail-only devices, class I GMP-exempt devices and some low-risk devices listed on the FDA Global Unique Device Identification Database (GUDID). In the EU, only medical devices that are custom-made or investigational-use devices are exempt from the UDI requirement, while all other products and low-risk devices require product information to all listed on the European Union Databank for Medical Devices (EUDAMED).
As UDI systems expand into more global markets, each with slight variations in requirements, keeping track of what’s required by which agency and how to provide it can be extremely overwhelming. We’ll help you navigate the complicated process to ensure you comply with each.
With intelligence on the most up-to-date requirements, our global regulatory consultants will help you:
July 28, 2015
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