UDI Services

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:

  • Understand what needs to be done and when
  • Identify UDI traceability requirements for each regulatory body
  • Gather and organize the required data
  • Prepare your submissions

Resources

July 29, 2015

White Paper – 4 Factors to Consider When Developing Your mHealth Product

4 Factors to Consider When Developing Your mHealth Product Successful FDA submission of your mHealth product not only hinges on the accuracy of your data and reliability of your software, but on...
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February 18, 2021

5 Mistakes Medical Device Startups Make

Startups are the lifeblood of medical device innovation. Without universities researching ways to solve pressing healthcare problems or doctors with experience in a particular field who have an idea to develop a prototype medical device that could help patients, the future technologies needed to help save lives wouldn't happen. But the long, arduous road through the FDA submission process to get market approval can take a long time and cost a lot of money without help. Sterling Medical Devices has been helping startups through the FDA approval process since 1998 without ever having a submission rejected.
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Breathing-Pacemaker

September 8, 2020

Breathing Pacemaker

Sterling Medical Devices performed design services for a Class III breathing pacemaker with Major Level of Concern software, intended for use by patients who have lost neurological control of respiration. This life-sustaining device is comprised of two main components: an internal passive receiver and an external controller....
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