UDI is coming. Is your EUDAMED data strategy ready? 

The European Database for Medical Devices (EUDAMED) is more than just a regulatory requirement. It is crucial for ensuring transparency, traceability, and safety in the European market for medical devices. 

EUDAMED consists of six modules: Actor Registration; Unique Device Identification (UDI) and Device Registration; Notified Bodies and Certificates; Vigilance and Market Surveillance; Clinical Investigations and Performance Studies. Among the modules already in operation is UDI/Device Registration, which will require medical devices to be registered starting in 2026. That's reason enough to take a closer look at UDI.  

UDI – the basis for transparency 

UDI is a globally recognized system for the unique identification of medical devices. A numerical or alphanumeric code makes every device on the market uniquely identifiable. The aim of UDI is to improve traceability throughout the entire lifecycle, prevent counterfeiting, increase patient safety, and reduce medical errors. 

Implementation plan: Time is pressing 

From January 2026, the transmission of the UDI to EUDAMED will be mandatory for devices newly placed on the market. From July 2026, UDIs for devices already on the market must also be registered in EUDAMED. This applies to manufacturers, authorized representatives, and importers of medical devices in accordance with MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Medical Device Regulation), as well as to manufacturers of system/procedure packs for these devices within the EU. Manufacturers from non-EU countries who market their products in the EU must have an authorized representative here. 

This means that all these companies must not only implement a labeling system, but also regularly submit complete, accurate, and up-to-date product-specific data to EUDAMED in accordance with the requirements. 

Experts recommend that the corresponding test phase should be completed by July 2025. This deadline is important because many medical device manufacturers and other affected parties still need to compile the necessary data and establish a process, while solution partners, consultants, and the UDI Helpdesk are already reaching their capacity limits.    

The challenge lies in data quality – and capturing all the details 

Manufacturers are faced with a complex data management task. The UDI consists of two parts:  

The UDI-DI (Device Identifier) is used to identify a product model and remains valid throughout its lifecycle. However, if significant changes are made to the product, a new UDI-DI is required, e.g., when the trade name is changed or a new product version is released.  

The UDI-PI (Production Identification) identifies the production unit of a product using the serial and lot number, the software identification, and the date of manufacture and/or expiry.

Much of this data is spread across different systems, formats, and departments. Manual exports, Excel spreadsheets, or unstructured data sources increase the risk of inconsistencies and incorrect transfers. The result: delays, queries from authorities, or even restricted market approval. Manual data transfer also makes traceability considerably more difficult.  

PLM software as a central data hub 

Users of product lifecycle management (PLM) software such as Windchill have an advantage here: PLM acts as a central hub for product data. Information required for UDI-DI is already available in Windchill in a clearly structured format: all product-related data—from technical specifications and regulatory information to change histories—is managed centrally and can be made available flexibly. 

This eliminates the tedious manual consolidation of data from different sources. Instead, users can extract UDI-relevant information directly from Windchill, validate it, and prepare it for transfer. 

Automated data transfer to EUDAMED and back to your own system 

PTC is the only provider of PLM solutions that automates product data management: Through its partnership with osapiens for Medical Devices (BYRD Health), Windchill users can automatically transfer the data required for their UDIs directly from the PLM software to osapiens for Medical Devices (BYRD Health) via the BYRD Connector. Here, it is bundled and transferred to EUDAMED in a regulatory-compliant manner. 

Not only does PTC's BYRD Connector enable data to be transferred to regulatory authorities; companies also receive feedback from regulatory authorities on the status of the process directly in Windchill. This provides teams the opportunity to react quickly and avoid delays in registration.   

Windchill+ BYRD Connector support manufacturers on a global level 

In addition to EUDAMED, which is operated by the European Commission, there are already other UDI databases worldwide such as the GUDID (Global Unique Device Identification Database) of the US FDA (Food and Drug Administration) and separate UDI databases of the Chinese NMPA (National Medical Products Administration); the Saudi Arabian SFDA (Saudi Food and Drug Authority); the Australian TGA (Therapeutic Goods Administration); and the South Korean MFDS (Ministry of Food and Drug Safety). Other countries are also planning their own UDI systems, including Switzerland, Australia, Brazil and Canada.

Global UDI strategies required 

Medical device manufacturers therefore need to establish a global UDI strategy, as the requirements of the respective regulatory authorities vary in terms of the data required, the data formats and protocols, and the type of data transmission. 

Windchill, in combination with the BYRD Connector, also supports manufacturers on a global level. As with EUDAMED, the individually required product data is transferred to the various UDI databases worldwide in the respective format, and feedback from the regulatory authorities is sent back to Windchill. This means that global requirements can be met with a single, validated platform. 

Seeing EUDAMED as an opportunity for digital excellence 

The UDI requirements under EUDAMED are not a one-time project, but part of a long-term digital transformation in medical technology. Manufacturers who invest early in integrated, scalable data strategies benefit twice: through sustainable compliance and more efficient processes.