by Adam KROLAK
Tuesday, September 13, 2022

Design your production marking system to meet UDI requirements

Regulatory requirements for product labeling present both benefits and challenges for manufacturers. This is certainly the case for the U.S. Food and Drug Administration’s (FDA) classification of cosmetic products such as toothpaste with medical benefits (and similar “cosmetics-related” frequent use substances or mixtures) as medical devices within its Unique Device Identification (UDI) system.

The FDA’s UDI system aims to create a single unified approach to enable the identification of medical devices from distribution through to use, with manufacturers responsible for ensuring that the product label includes a globally unique device identifier. Establishing or adapting production marking systems in response to these types of requirements can appear a complex proposition at the outset. However, with an effective combination of software and hardware, manufacturers can minimize disruption to their production processes while keeping pace with changing regulatory demands.

Clear benefits for consumers and companies

The UDI system provides a host of benefits for consumers, industry and healthcare providers. It ensures that products are safe and reduces the risk of customers being misled. This is because relevant certification-specific product claims are independently scrutinized and justified by a Notified Body. Product review through the UDI involves not only proving the product’s performance and scientific and clinical claims, but also the completion of an extensive audit of the manufacturer’s quality management system.

Design your production marking system to meet UDI requirements?

Easier and more extensive reporting

The UDI system enables companies to undertake more accurate reporting, reviewing and analysis of adverse events so problem devices can be identified, recalled and adjusted or removed from the market more quickly. Because the UDI helps healthcare professionals and others to more rapidly and precisely identify and obtain important information about a device, it also reduces instances of medical errors and supports more informed patient treatment.

Higher quality data

The UDI is helping to create a huge volume of trackable data for medical devices and supporting the development of valuable real-time analytics. Enhanced analysis of devices on the market through this more standardized approach enables the faster discovery of flawed medical devices and more effective management of recalls.

More insight in the fight against counterfeiting

As well as supporting a more informed response to medical emergencies, the UDI system provides a valuable foundation for a global, secure distribution chain and is playing a key role in addressing product counterfeiting and diversions.

The challenges of UDI labeling and marking 

UDI labeling requirements are highly detailed and rigorous as labels must include a Device Identifier (DI), a Production Identifier (PI) and a Barcode which incorporates both the DI and the PI. Companies producing cosmetic products which are classed as medical products must ensure their production processes have the scope for additional information to be prepared and printed onto the product packaging. This type of information has to be carefully generated and managed, as does the design and print of the product label - all bringing further pressure to already squeezed production lines.

The requirements often mean that either:
  1. The production line needs to slow down to mark additional content, or
  2. The marking system needs to be upgraded to be able to mark the additional content with sufficient quality and speed. 
It is also important to consider the added complexity created by the use of 2D matrix code, the number of characters to be included, and the balance of time to speed.

Solving the UDI labeling conundrum

Ensuring that a product marking system meets UDI regulations demands both software and hardware with a number of key capabilities:

Software - An effective approach should include a software package capable of seamlessly delivering advanced coding features (2D Data Matrix, DotCode, Variable Data Print (VDP) and more), as well as digital communication for industrial environment and enterprise-level systems like enterprise resource planning (ERP), and sometimes CRM. The communication protocols should include options for TCP/IP Ethernet, RS-232/USB, PROFINET, OPC, Krones Checkmat etc. 
Markem-Imaje’s CoLOS solution is an example of this type of system. As an information management system, it ensures brand integrity and compliance with regulations such as UDI. CoLOS uses structured message design and integrates with information and ERP systems to streamline message creation and printer setup during production while ensuring the security and traceability of printed information. 

Marking system - In addition to software as outlined above, an effective solution also needs to include an efficient marking system to fulfill increased marking requirements without restricting the speed of the production line. A valuable option in this scenario is a high power, ultra-fast digital CO2 laser system.

Keeping up with UDI regulations

With the right approach, manufacturers of cosmetics products such as toothpaste and similar “cosmetics-related” frequent use substances can adapt in a timely way to their classification as medical devices. For companies not yet impacted by these regulations, it is worth being aware that UDI requirements are still evolving and may be revised to include other types of products. Added to this, while many countries already have UDI databases in place, regulators in a number of other countries are currently considering adopting a UDI system of their own.

At Markem-Imaje, our solutions provide a turnkey mark and read solution for medical device manufacturers who need to comply with UDI regulations. We are unique in that we offer integrated printer and scanner/vision validation functionality, bundling our printer, camera, and controls together to provide a one screen turnkey solution, all backed by a global support infrastructure with proven medical device experience.

Contact us to discuss your UDI production marking requirements.
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