Patient safety is the top priority in medical technology. Clear and consistent medical-device labelling is fundamental to this - from manufacturers to specialist retailers and from hospitals to the patient. This maintains full transparency along the supply chain. Unique Device Identification enables those responsible for procurement and materials management to access regulatory specifications held in central databases. Serial numbers and expiry dates as examples of this. When a medical device is marked "UDI-compliant", no further details are required. In the foreseeable future, all medical devices in any risk class will require clear and machine-readable labelling.
UDI (Unique Device Identification) made easy
With the complete turnkey package from TRUMPF you can mark medical devices permanently and reliably using lasers and software from a single source. Increasingly medical technology products now need to be marked with a unique UDI code (UDI = Unique Device Identification) that are traceable across the entire supply chain. The most important requirement is for markings to be permanently legible, something that is frequently achievable only with laser marking.
When is UDI coming and where is it already standard?
Export of medical technology to the USA
To export to the USA in the future, medical technology must have a unique UDI label.
Plans for Europe
The requirement to clearly label all medical devices is also planned for Europe.
Risk classes II und III
Medical instruments in risk classes II and III are already subject to mandatory UDI labelling.
New directives and deadlines
From September 2020, instruments in risk class I must also be labelled in accordance with UDI.
What is UDI (Unique Device Identification)?
Unique Device Identification (UDI) refers to a globally standardised system for identification in medical production. A UDI marking consists of two parts – a machine-readable code and a human-readable code. The machine-readable part is represented either as a linear barcode or as a 2D data matrix code. The human readable part can be represented as numbers and letters.
What is the purpose of the UDI system and what requires marking?
Do all medical devices require UDI marking?
All medical products intended for sale in the United States must have a UDI code in future. The European market is also planning to make UDI labelling mandatory in the new Medical Devices Directive. The goal is clear: a globally standardised UDI system. The medical technology industry in every market is being advised to label their products with UDI codes in anticipation of new legal requirements.
Which standards exist for UDI labelling?
UDI labelling of medical devices is based on specific standards. To this end, the US Food and Drug Administration (FDA) has accredited the HIBC, GS1 and ISBT 128 standards. Generally labels always consist of two parts: the "DI" (Device Identifier) and the "PI" (Production Identifier). The DI, which is identical for each item, includes the ID of the manufacturer or labeller as well as the reference code of the product. In contrast, the PI is dynamic, containing information such as expiry and manufacturing dates the serial numbers. The global data exchange network GUDID enables manufacturers to forward product information to the American FDA UDI database.
Which UDI regulations exist within the EU?
In contrast to the US FDA regulation, the EU is introducing a new identifier based on the European Union Medical Device Regulation (EU MDR) – "Basic UDI-DI". This enables medical devices with similar characteristics to be grouped in the EU approval database EUDAMED. The device can only be submitted to the authorities responsible for approval after the medical device manufacturer or an authorized representative has allocated the new identifier.
The complete package from TRUMPF
TRUMPF has a broad range of marking lasers as well as customisable software solutions. Customers can use them to create UDIs from their own databases and apply the markings to medical products. Quality control and documentation functions are also available when required. TRUMPF customers get high quality markings from this complete package while also benefiting from TRUMPF solutions for UDI-compliant marking and process reliability.
1. Access to database
The software is linked to databases. Reading information into the system via external hand scanners is also possible, for example.
2. Production data input
Data is available from the database or read out using a hand-held scanner.
3. Create UDI code
The UDI module creates a rule-compliant code from UDI-relevant data and individual extensions.
4. Component and position recognition
VisionLine image processing automatically detects the component and its exact location and position. The software forwards the information to the controller which makes the marking in the precise position.
5. Marking laser
The TRUMPF laser marks the workpiece with a durable, corrosion-resistant and high-contrast marking that remains machine-readable and visible to the human eye even after numerous cleaning cycles.
6. Optional code content capture
With TRUMPF process sensors, even the end quality control is very easy. This is how TRUMPF image processing solutions enable UDI-compliant codes to be recognized, read out and their quality evaluated using various methods.
7. Optional marking data check
Marked data can be compared against the database and stored for documentation purposes and can contain additional information when required. This includes information on UDI code content and quality, or on the machines involved in the process. This ensures proper documentation of the component and marking even after many years.
TRUMPF is a GS1 Solution Partner
With us, you label your medical devices UDI-compliant
To guarantee the traceability of medical devices, accredited standards are applied and issued by one of the four authorities: GS1, HIBCC, ICCBBA and IFA GmbH (an information service provider for the German pharmaceutical market). The most frequently used standards are GS1, HIBC and ISBT 128. TRUMPF is a recognized GS1 Solution Partner.
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