How does the UDI system work ?

UDI (Unique Device Identification) is a worldwide system used in the medtech sector to uniquely identify medical devices and ensure their traceability. The introduction of the UDI system represents an important step towards standardisation and improvement of safety and efficiency in the medtech sector.

The UDI system is internationally recognised and supported by various regulatory authorities, including the US Food and Drug Administration (FDA) and the European Union (EU).

The UDI code in machine-readable format on the product packaging contains various information such as the manufacturer, product type, batch number and expiry date. This allows patients, doctors and other stakeholders to accurately identify the product and easily access information about it.

What are the challenges for medical device manufacturers?

For MedTech manufacturers, the implementation of the UDI system brings some challenges. As each product has to be provided with a unique identifier, the collection, management and regular updating of UDI data in the systems and processes of the medical devices company is required. Therefore, investments in new technologies and software solutions are required to meet the UDI requirements.

As there is no global authority, UDI requirements vary from one authority to another. MedTech manufacturers must therefore ensure that UDI data is properly updated in the relevant databases and registers of the relevant authorities, FDA for the US and EUDAMED for the EU.

How can EUROPE IT support them ?

Europe IT Consulting is a leader in information technology and consulting services for the medical device industry. We offer comprehensive solutions specialised in Unique Device Identification (UDI) and related requirements. Our goal is to support MedTech companies in providing and transferring the data required by the authorities. Thus, we simplify the process and the interaction between their ERP system and the authorities and ensure that the regulatory requirements are met.

Our UDI compliance services:

  • SAP UDI-Add-On: Our powerful SAP UDI add-on, helps medtech companies seamlessly meet the UDI requirements of the European Union (EU) and the US Food and Drug Administration (FDA). With our solution, you can easily capture, manage and integrate UDI data into your existing SAP systems. This simplifies compliance with UDI requirements and improves efficiency in your business processes. Our software is regularly updated with updates to ensure you are always compliant.
  • Excel Template: If you are currently using an ERP system other than SAP, we also offer an Excel template that allows you to access your data and simultaneously transfer it to our SAP system, which we then forward to the appropriate authority.
  • Barcode-Generatoren:We also offer state-of-the-art barcode generators to help you create the machine-readable codes for UDI labelling of your medical devices. Our user-friendly tools allow you to quickly and accurately generate barcode labels that comply with international standards.
  • MedTech Consulting:Europe IT Consulting has an experienced team of IT experts and UDI consultants to help you optimise your IT infrastructure and implement effective UDI strategies. We offer customised consulting services to meet your specific needs and ensure that your UDI implementation runs smoothly. From system integration to data management, we help you take full advantage of UDI and improve your business results.

By working with Europe IT Consulting, MedTech companies benefit from our extensive expertise in UDI and medical device regulations. Our tailor-made solutions help you to meet compliance requirements, improve the safety of your products and increase your operational efficiency. Rely on our experience and let us work together to overcome the challenges of UDI to put your company on the road to success.

Are you interested?

Contact us today to learn more about our UDI solutions and MedTech consulting services and how we can help you achieve your goals.

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