What are some of the common challenges when it comes to integrating unique device identification (UDI) into a medical device manufacturer’s quality management system (QMS)?

Redica Systems GMP Medical Device Expert Mark Agostino provided insight into this question during the Redica Systems webinar, “Unique Device Identification | Aligning to a Single Approach.”

He identified two particular challenges when it comes to integrating UDI requirements into a QMS: varying enforcement timelines and nomenclature. 

[Related: For a taste of Redica’s actionable intelligence, download a FREE report showing FDA 483 observation trends involving UDI-related issues.]

UDI Form 483s analysis

Timelines for Enforcement

As you can see from a sampling of four countries’ UDI implementation timelines in Figure 1, timelines for regulatory agencies to enforce UDI requirements vary. According to Agostino, “the enforcement of a UDI on a device is going to vary significantly country by country.”

Figure 1 UDI Enforcement Timelines
FIGURE 1 | UDI Enforcement Timelines

“[Figure 1] shows the disparity around the timelines. The challenge, as an organization, is that you are going to need to be aware of where you market your devices,” he said.

Device Nomenclature

“Another challenge for your QMS in an organization is going to be device nomenclature,” Agostino said. “You have the European Medical Device Nomenclature, the EMDN Code, that is going to be utilized by EUDAMED. Then, you have the Global Medical Device Nomenclature (GMDN) and that is currently utilized by the U.S. FDA in their database.”

Other regulatory agencies will also adopt different nomenclatures. Depending on the country, they may adopt either the EMDN Code or GMDN. These agencies could also potentially adopt a country-specific nomenclature or none at all. 

Medical device manufacturers need to ensure that the correct nomenclature is used when UDI data is submitted to a database. 

These different nomenclatures present a challenge, in particular, for post-market activities. The QMS will need to account for these nomenclatures as medical device products are distributed throughout these various markets around the world.  

Agile QMS Needed as Regulations Evolve

Ultimately, Agostino explained that a medical device manufacturer’s QMS must be agile enough to manage UDI throughout the product lifecycle in addition to accounting for the different requirements throughout the world. 

“Understand that the regulatory landscape for medical devices and UDI is constantly evolving,” he said. “There are a lot of elements that still need to be enacted in the various countries, so the UDI platform will be evolving as more countries enact changes. This is going to be one of the ongoing challenges for medical device manufacturers.”

Additional Resources

Webinar – Unique Device Identification | Aligning to a Single Approach

How Medical Device Manufacturers Can Integrate UDI into a QMS

The 7 Most Common FDA 483 Observations Involving UDI

UDI Compliance for Medical Devices: Part I

UDI Compliance for Medical Devices: Part II

UDI Form 483s analysis