MedTech Regulatory Affairs Leaders


How to simply manage your EUDAMED attributes

Have you ever lost track while managing EUDAMED attributes using Excel spread sheets? You might have wondered: Is the information between Basic-UDI and UDI-DI consistent with each other? Who entered which information and who finally authorized it? Can we really upload this version to the EUDAMED website? Once data has been incorrectly uploaded and approved in the EUDAMED database, some of it cannot be changed again. In the worst case scenario, a new UDI-DI needs to be issued to implement changes in the data.

EUDAMED Manager was developed for medical device manufacturers to keep track of their UDI attributes.


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EUDAMED in a nutshell

EUDAMED stands for „European Database on Medical Devices“. It is a central database developed by the European Union to collect and exchange information about medical devices placed on the market within the EU. The database serves as a tool for monitoring and regulating medical devices to ensure the safety and performance of these products. EUDAMED contains information on market participants, medical device approval, clinical trials, recalls and other relevant data that can be used by competent authorities and other stakeholders. Since the introduction of the MDR or IVDR, manufacturers of medical devices or in-vitro diagnostics have had to enter certain data about their products in EUDAMED and keep it up to date. The exact timelines for data provision may vary depending on the product category and regulatory requirements. One of the biggest challenges is the in-house management of the huge amounts of data required for EUDAMED compliance. This includes collecting, organizing and accurately entering data about your products, including technical specifications, clinical evidence and regulatory certificates. The data is mainly organized using so-called Unique Device Identifiers (UDI). The UDI consists of a unique combination of numbers or letters that allows a specific medical device to be individually identified. Unique labeling is intended to enable manufacturers, regulators, healthcare providers and other stakeholders to quickly and accurately access information about a product, especially in the event of recalls, quality issues or other safety concerns.

Consistency Challenge - Data has to be maintained on different levels

A particular challenge for manufacturers is that EUDAMED UDIs have to be defined and maintained at different levels:

Basic UDI:  The definition of UDI at the level of product groups (or product families) is reasonably clear. This is the so-called basic UDI. For example, general information on classification, certificates or assigned clinical studies are reported there.

UDI-DI:  Multiple specific medical devices (products that are listed in the sales catalog) can be assigned to a product group. These are the so-called device identifiers (UDI-DI). Things become confusing on this level. Devices have their own UDIs for the unit of use, possibly different UDIs for different packaging levels or so-called direct part marking. It is also only defined at the device level how the production units are clearly and traceably identified (e.g. by specifying batch numbers, expiry date, etc.), which EMDN nomenclatures are to be used for the device, which critical substances are part of the device (e.g. carcinogenic, mutagenic or endocrine substances), which medicinally active substances are contained, which (standardized) critical warnings are contained in the instructions for use, in which sizes the device is available and, if applicable, which was the direct previous version of the device.

How to prepare data upload

EUDAMED accepts data in a structured electronic format that complies with the technical specifications established by the European Commission. These technical specifications include data formats, data elements, data fields, validation rules and other requirements that ensure that the data entered is consistent, precise and interoperable.

In particular, there are currently three different input options available:

  • Manual entry on the EUDAMED website
  • Bulk upload of data using structured files (xml)
  • Direct database connection using DTX standard


Once data has been uploaded and approved, some of it cannot be changed again – a new UDI-DI may have to be issued in order to implement changes in the data.

Due to the complexity of the diverse requirements and the possible consequences of incorrect entries, we recommend preparing the UDI or EUDAMED data in-house prior to officially uploading the data, checking for possible inconsistencies and, if necessary, having them approved by various internal stakeholders.


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