FAQ on UDI

Everything you need to know about UDI-compliant laser marking in medical technology

The US FDA (Food and Drug Administration) is introducing UDI marking (Unique Device Identification) - a legal requirement for the unique identification (product number and data matrix code) of medical devices - to ensure clear and secure traceability throughout the entire product life cycle. Implementation in compliance with the regulations is a major concern for manufacturers of medical devices who are looking for a practical and economical marking solution. We answer the most important questions about secure UDI marking.

Medical clamp marked with UDI | FOBA Laser Marking

What is the reason for the implementation of UDI?

The UDI system addresses all of the following aspects:

More efficient product recalls.
Improved counterfeiting protection.
Simplification of data entry and accessibility with different systems.
Security throughout the entire supply chain.
Field Safety Corrective Action – FSCA.
Better identification, documentation and prevention of incidents.
Prevent medical errors from occurring.

Additionally, the labeling system enables the simplification of logistics, ordering and delivery processes.

How is a UDI code structured?

In their structure, UDI codes consist of a primary code (DI, Device Identifier) and a secondary code (PI, Production Identifier). The former is used to identify the labeler and the product (also known as the reference code). The product identifier (DI) is a globally unique product code with which a product can be uniquely identified and which is stored in the central database. The production identifier (PI), on the other hand, is not mandatory and consists of optional dynamic information such as batch or lot numbers, serial numbers, expiry or manufacturing dates, etc.

According to 21 CFR 801.40, medical devices have to carry a UDI that is represented in two forms:

Easily readable plain-text (HRI/Human Readable Interpretation), alpha-numeric characters
AIDC technology (Automatic Identification and Data Capture), which means a machine readable code (barcode/2D code)

In case the UDI code is applied as a permanent direct mark, it must be in either or both (1) easily readable plain-text and (2) AIDC form or alternative technology (see 21 CFR 801.45).

UDI marking on stainless steel umbilical cord scissor. Marking procedure: Annealing with a fiber laser marker.

UDI code examples

GS1, HIBC, ICCBBA: Which code is suitable for UDI marking?

The FDA has accredited three organizations as UDI issuing agencies: GS1, HIBCC (Health Industry Business Communications Council) and ICCBBA (International Council for Commonality in Blood Banking Automation). Both the Health Industry Bar Code (HIBC) and the GS1 code are equally suitable for the UDI compliant marking of medical products and devices. The ICCBBA UDI code, as approved by the FDA, is best adapted to identify products of human origin (like plasma or transplants).

UDI codes are graphically depicted in an assembly of two forms: a human readable plain text of alpha-numeric characters and a machine-readable code (see above). There are different forms of machine readable codes available: The GS1-128 linear bar code, the GS1 data matrix code from GS1, the HIBC linear bar code and the HIBC data matrix code, and the linear ISBT 128 and 2D code from ICCBBA. Depending on the accredited issuing agency, each product can receive its unique code in any of the above formats.

FDA compliance dates: Which products have to be marked with a UDI code as from when?

Where and when a UDI code has to be applied to a product depends on its risk class and intended use. The UDI system differentiates between the marking of the packaging of labels and direct marking on the product. If the product is reused and/or reprocessed before each use, the UDI marks need to be directly applied on the device. The last deadline for the marking of packaging and labels will be reached in 2018. At that point, the packaging and labels of all class I – III products must carry a UDI code in plain text and machine-readable form, using automatic identification and data collection (AIDC) technology.

The FDA has defined three risk classes, based on the degree of control needed to guarantee the safety and effective use of the products.

Class I (low risk, general controls): e.g. bandages, stethoscopes, surgical scissors, dental floss, mechanical wheelchairs.
Class II (moderate risk, general and specific controls): e.g. infusion pumps, surgical sutures, bone screws, syringes, condoms, powered wheelchairs.
Class III (high risk, general controls and premarket approval, life-saving and life-sustaining): e.g. heart valves, knee prosthesis, pacemakers, automated external defibrillators.

The UDI marking compliance deadlines are phased in stages based on product risk classifications. Codes must be applied on labels and packages or on the product itself (Direct Part Marking DPM). According to the FDA, DPM is required for implants and devices intended to be reprocessed or reused over an extended period of time (several months or years). The permanent marking is required as it is expected that such devices will be separated from their original packages.

The compliance deadlines of the FDA regarding Direct Part Marking (for devices that are intended to be used more than once and intended to be reprocessed before each use) are as follows:

2015: Implantable, life-saving, life-sustaining products.
2016: Class III products.
2018: Class II products.
2020: Class I products.

(Visit the FDA-website for more details and latest information.)

A directly marked UDI code is only required if the corresponding products are processed, for example cleaned, sterilized or passivated, before their use. Even products that do not necessarily have to bear a directly marked code (like sterile packaged implants for single use) get marked for functional reasons and fraud prevention.

Is laser marking suitable for marking UDI codes?

One of the major challenges in connection with UDI is the implementation of the appropriate technology for direct labeling. The FDA does not prescribe which of the available methods should be used. In addition, not every process is suitable for safe and UDI-compliant direct marking. It is therefore not always easy to choose the most suitable method.

The laser marking process is ideal for the direct marking of medical devices with the Unique Device Identifier. It meets all the criteria that are relevant for secure product marking in accordance with medical standards and UDI requirements. In addition, camera-based laser marking devices offer advantages in terms of the cost-effectiveness and reliability of the marking process.

How vision-based laser marking helps to mark UDI codes reliably and efficiently

A vision-based laser marking workflow, like HELP (Holistic Enhanced Laser Process), helps facilitate and streamline the marking process. An integrated camera ensures process reliability before, during and after laser marking. HELP is a three-staged closed-loop medical device marking process. Prior to marking, the right parts are validated, then the marking position is automatically aligned with the part so that only the correct mark will be applied in the correct position. Finally, the integrated vision also verifies the marked contents. Utilizing this approach, scrap due to marking errors can be reduced by up to 80 percent.

Although many manufacturers are requested to implement several essential modifications in their production process, one can assume that the traceability of medical devices will pay off in the end. Not only for the safety of patients, but also for streamlining the companies’ manufacturing and logistics supply chain. Laser marking with integrated vision appears to be a sustainable and economic solution in response to the actual marking requirements.

UDI in the USA and Europe

The primary purpose of the UDI system is to increase patient safety and enable sustainable traceability of products. The FDA directive applies to medical devices that are manufactured in or imported into the USA and sold on the US market. Corresponding laws also apply internationally: the European Union recently introduced UDI requirements as part of the new MDR (Medical Device Regulation), which will apply in stages from 2020.

Both systems stipulate the standardization of characters and the transmission of data to a higher-level database. The central instance of the American UDI system is the “Global Unique Device Identification Database” (GUDID), which records and catalogs the UDI of each individual product. The European equivalent is EUDAMED, the “European Database for Medical Devices”, which is also used for the central administration of all medical devices.

UDI Marking and Digitalization: ERP Software

To make workflows more efficient, standardize processes and avoid extra work, digitization based on ERP (Enterprise Resource Planning) software can bring many benefits. After all, interlocking data processing can dovetail all steps in the company, from master data to serial direct marking. This also ensures optimal connection of production technology to ERP systems and databases.

Digitization measures in this area can be introduced at any time; both products already on the market and additional UDI data can be newly integrated into the system. Regarding the upcoming MDR, all UDIs that will be required for EUDAMED in the future can already be maintained in advance in the ERP. The processing of this data is also the basis for the preparation of serial labeling for laser marking or the provision of the 2D UDI codes assigned per part.

Medical device manufacturers should ensure that the ERP used is suitable for UDI labeling and that the underlying regulations (e.g. DIN EN ISO 13485, MDR, 21CFR820) are taken into account during digitization.

Preconfigured and validation-capable software solutions then facilitate not only the implementation, but also the validation required in medical technology. This is because the integrity of all relevant data is also part of the validation, which in turn is a mandatory for product quality and thus for patient safety.