UDI / Labeling

UDI and labelling are essential to the life sciences industry as they enhance patient safety, improve supply chain efficiency and ensure regulatory compliance. Clear labelling of medical devices facilitates traceability, enabling rapid response to product recalls and better inventory management. In addition, UDI promotes transparency and builds trust in medical devices by providing accurate and accessible product information.

Key Components of UDI

UDI stands for ‘Unique Device Identification’ and refers to a system that allows medical devices to be uniquely identified through the use of a specific, globally unique device label. This labelling system was pioneered by the US Food and Drug Administration (FDA) and is increasingly being adopted around the world. It aims to improve the safety of medical devices, facilitate traceability and increase efficiency in the healthcare sector.

The two main components of the UDI are:

  1. UDI label: Each medical device carries a label with a unique code consisting of two parts.
    • Device Identifier (DI): A fixed code that uniquely identifies the device and its manufacturer.
    • Production Identifier (PI): A variable code that contains additional information such as the date of manufacture, batch or serial number and expiry date.
  2. UDI database:The codes and associated product information are stored in a central database. This database is publicly available, increasing transparency and enabling healthcare providers to quickly access important product information.

Aims and Benefits of the UDI System

The UDI system plays a vital role in modern healthcare by improving the traceability of medical devices and contributing to the safety and efficiency of their use.

The aims and benefits of the UDI system are:

  • Improved Patient Safety: Accurate identification and traceability of medical devices means that potential risks can be better managed and problems can be responded to more quickly.
  • Efficient Recalls: In the event of a product defect, the UDI system makes it easier to quickly locate and remove affected products from the market.
  • Simplified Inventory Management: Hospitals and other medical facilities can more accurately manage their inventory.
  • Improved Healthcare Research: Researchers can more easily collect and analyse specific medical device data, helping to improve product quality and patient care.

Tasks in the Field of UDI

People working in the field of UDI and labelling have diverse and specialised roles. These roles help to ensure compliance and optimise the management of product labelling and data. Here are some typical roles that fall into this area of work:

  • Regulatory Compliance:
    • Ensure that all labelling and UDI implementations comply with applicable national and international laws and regulations, such as FDA, EU MDR and other global regulatory bodies.
    • Prepare and submit required documentation and UDI data to relevant regulatory authorities and UDI databases.
  • Create and Manage UDI Labels:
    • Develop and implement UDI labels for new and existing medical devices, including deciding on the type of labelling (barcode, RFID, etc.).
    • Oversee label production and quality assurance to ensure label accuracy and readability.
  • Data Management:
    • Entering and updating production information into the UDI databases to ensure accuracy and accessibility of data.
    • Managing the internal databases and information systems used for UDI tracking.
  • Training and Support:
    • Training of internal staff and external partners (e.g. suppliers, distributors) on UDI requirements and processes.
    • Providing technical support and advice on UDI related issues and solutions.
  • Monitoring and Reporting:
    • Regularly review compliance and performance indicators related to UDI and labelling.
    • Provide reports and analysis on the performance of the UDI system and identify opportunities for improvement.
  • Working with Stakeholders:
    • Liaise with manufacturers, healthcare organisations, distributors and regulators to promote efficient implementation and use of the UDI system.
    • Participate in industry meetings and working groups to share best practices and discuss current trends and developments in UDI.

These activities are essential to ensure the integrity and efficiency of the UDI system and to improve the safety and traceability of medical devices.

Differences between UDI and Labelling

UDI and labelling are related but distinct concepts in the labelling and management of medical devices. Here is a clear distinction between the two:

  1. Unique Device Identification (UDI):
    • Mandated by regulatory bodies such as the FDA and the EU, the UDI system aims to improve the safety and traceability of medical devices.
  2. Labelling:
    • Labelling generally refers to all information provided on or with a medical device, including instructions, warnings, ingredients and identification numbers. It goes beyond the UDI and includes everything that is stated on the label or packaging of the device.

In summary, UDI is a specific type of labelling that focuses on the unique identification of each medical device. Labelling, on the other hand, covers a wider range of information that is placed on devices to ensure that they are used safely and correctly. UDI is part of the overall labelling process, specifically designed for traceability and regulatory compliance.

 

Are you looking for UDI / Labelling personnel or would you like to develop your career in this area? Contact us and we will find the perfect match for you in your specific area.

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