Contact Us
Close Form

Interested in learning more about how we can work together in your current or next medical device design project?

Just fill out this form and we’ll be in touch!

  • This field is for validation purposes and should be left unchanged.

Wherever you are in your product development lifecycle,
Sterling can help.

P: 201-877-5682
F: 201-301-9169

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


July 28, 2015

Is Your Medical Device an Entry Point for a Cyber Attack?

The Internet of Things (Iot), the continual proliferation of mobile medical devices, and the growing amount of data in hospital systems are trends medical device manufacturers should closely follow....
Read More >
View More Blogs

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.
Read More >
View More Videos
people developing a product

November 23, 2020

Sterling Helps Print Parts Win Contract with City of New York for Production of Medical-Grade Nasal Swabs

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....
Read More >
View More Case Studies

Need help with your medical device?

Let Sterling Medical Devices show how to bring your idea from concept to prototype to
FDA/CE approval with a free custom project analysis.
Request Free Analysis