Certification and Registration
US. Medical Device UDI & GUDID Registration
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U.S. Medical Device UDI & GUDID Registration
Starting from September 24, 2022, medical devices exported to the United States must, within the applicable compliance timeline, establish product UDI, ensure that packaging and labels bear UDI codes, and complete GUDID database upload and maintenance in order to meet FDA requirements.
What is UDI?
Unique Device Identifier, referred to as UDI, is a unique numeric or alphanumeric code used to identify medical devices in the US. market and other markets around the world. These dedicated codes are used by the US. Food and Drug Administration (FDA) as part of its Unique Device Identification System and provide much-needed regulatory oversight.
UDI labeling enables each device to be identified throughout the entire manufacturing, distribution, and use process. The purpose of this identification system is to create a unified national and global language for the medical device industry, regardless of the product’s related risk, intended use, or classification.
The UDI system increases traceability and enables medical device manufacturers and FDA officials to respond quickly when patient safety is threatened due to a device issue.
What is the UDI Rule?
Since 2007, the establishment of a UDI system in the United States has been an ongoing process. Although there were delays in the FDA Amendments Act, the Final Rule on the Unique Device Identification System, namely the UDI Rule, is now a legal requirement for any medical device sold in the United States.
The UDI Rule and its related Unique Device Identification System are governed by the following:
Section 519(f) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 USC 360i(f), and
Section 614 of the Food and Drug Administration Safety and Innovation Act (FDASIA)
According to FDA, the UDI Rule provides solutions to the following needs of medical device manufacturers:
-Reduce medical errors
-Simplify the integration of device use information with data systems
-Provide faster identification of medical devices associated with adverse events
-Provide faster solutions to reported issues
-Provide faster and more effective solutions for device recalls
-Improve the focus and effectiveness of FDA safety communications
What is the UDI Format?
The UDI format follows a unified labeling system and generally includes the following:
Device Identifier (DI): a fixed and mandatory part used to identify the labeler and the specific model/version of the device
For companies applying for the first time, the DI number is assigned by the Data Universal Numbering System (DUNS), which is supervised by the UDI company Dun & Bradstreet, and can be assigned within 30 days after a request is submitted.
Production Identifier (PI): a variable part that represents the following combination:
-Place of production
-Date of production
-Serial number
-Expiration date
§1271.290(c) requires a different identification code for human cells, tissues, or cellular and tissue-based products (HCT/Ps) regulated as devices.
As the name suggests, a unique identifier is intended to be unique to only one device. This means that the UDI must be printed on all single-use device packaging and labels.
In addition, if the device is intended for multiple uses, the UDI must be printed directly on the device itself.
The UDI Rule also considers accessibility in both easily readable plain text and machine-readable text forms for Automatic Identification and Data Capture (AIDC) technology.
What is the mandatory deadline for devices to comply with UDI requirements?
The obligation to place the UDI carrier applies according to the following timeline.
|
Devices regulated under Regulation (EU) 2017/745 (MDR) |
Implantable devices and Class III devices |
Class IIa and Class IIb devices |
Class I devices |
|
Place the UDI carrier on the device label MDR Article 123(3)(f), Article 27(4) |
2021/5/6 |
2023/5/6 |
2025/5/6 |
|
Direct marking of reusable devices MDR Article 123(3)(g), Article 27(4) |
2023/5/26 |
2025/5/26 |
2027/5/26 |
|
Devices regulated under Regulation (EU) 2017/746 (IVDR) |
Class D IVDs |
Class C and Class B IVDs |
Class A IVDs |
|
Place the UDI carrier on the device labelIVDR Article 113(3)(e), Article 24(4) |
2023/5/26 |
2025/5/26 |
2027/5/26 |
How should the UDI appear on the device label or packaging?
-The UDI carrier, namely the Automatic Identification and Data Capture (AIDC) and the Human Readable Interpretation (HRI) representation of the UDI, should appear on the label or the device itself, as well as on all higher levels of device packaging.
-If there are obvious space limitations on the unit-of-use packaging, the UDI carrier may be placed on the next higher level of packaging.
-Higher levels of packaging should have their own independent UDI. Please note that shipping containers are exempt from this requirement.
-The UDI must appear in a plain text version/human-readable information (HRI) format and in AIDC technology. AIDC refers to any technology that conveys the Unique Device Identifier or Device Identifier in a form that can be entered into electronic medical records or other computer systems through an automated process. HRI consists of recognizable characters that can be easily read by people.
-If there are significant limiting factors that restrict the use of both AIDC and HRI on the label, only the AIDC format should be required to appear on the label.
-For devices intended to be used outside healthcare institutions, such as home care devices, HRI should appear on the label even if this results in no space for AIDC.
-For individually packaged and labeled single-use Class I and Class IIa medical devices, as well as Class A and Class B IVD medical devices, the UDI carrier is not required to appear on the packaging, but should appear on the next higher level of packaging. For example, a carton containing several individually packaged devices. However, in situations such as home healthcare environments, when healthcare providers are not expected to have access to the higher level of device packaging, the UDI should be placed on the packaging of the individual device.
-For devices specifically intended for point-of-sale retail, UDI-PIs in AIDC should not be required to appear on point-of-sale packaging.
-If the UDI carrier can be read through the device packaging, or can be scanned in the case of AIDC, the UDI carrier is not required to be placed on the packaging.
Which changes to medical devices require a new UDI-DI?
A new UDI-DI is required whenever a change occurs that may lead to incorrect device identification and/or unclear traceability. In particular, a new UDI-DI should be required when the following elements change:
-Name or trade name
-Device version or model
-Labeled as single-use
-Sterile packaging
-Sterilization required before use
-Number of devices provided in the packaging
-Key warnings or contraindications
-CMR/endocrine disruptors
One UDI-DI should be associated with one and only one Basic UDI-DI.
To learn more about FDA UDI, please contact SATISFY.
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