EUDAMED Data Dictionary

by Aug 29, 2019

Your pathway to EUDAMED data implementation.

Manufacturers of medical products should put a big red ring around 26 March 2020 on their calendars. From this date all product data must be stored in the European database, EUDAMED. But how to go about it? Uploading data and maintaining it in the database – isn’t that complicated? As a manufacturer you don’t want to be in the dark, which is why the European Commission has issued an “MDR EUDAMED UDI Data Dictionary”. This is a register with datasets relating to MDR-UDI and medical products which is designed to ensure seamless input of data into EUDAMED. The Data Dictionary explains in detail the data you should make available to EUDAMED for the “UDI Medical Device Registration” module. According to the European Commission there may be minor adjustments to come, but the dictionary contains all the key information you need so that you’ll always be sending the correct product data to EUDAMED in the future.

 

Where do I find the EUDAMED requirements?

  • Open the EUDAMED UDI Device Data Dictionary
  • Compare the EUDAMED requirements with the contents of your own database
  • Carry out a EUDAMED attribute analysis: First, compare all values in a column of a table (attributes). Then check the characteristics of the attributes in a table.
  • You can find more technical information on the website of the European Commission

The truly essential factor in storing your data in EUDAMED is comprehensive master data management. The corporate data dictionary for your medical products is key here. Therefore you should configure your database so that it is precisely aligned with EUDAMED requirements. The data dictionary can also help your IT department to compile the right information, data fields and system codes into one central document. A further advantage is that you will be back up to date with internal processes and on course with your data acquisition.

 

How is the corporate data dictionary used, analysed and created?

  • You will receive a comprehensive summary and mapping of external and internal requirements to help you put together optimal descriptions of your products.
  • Then a structured overview of attributes, code lists, validations, metadata, data sources, ownership and other elements is created.
  • The result is a guideline for internal communication of product content.
  • Data quality and efficiency is improved through data maintenance
  • You can find more information about data dictionaries in our blog data dictionary 101

 

There for you: our atrify service experts in the area of product content management

We advise 20,000 brands in over 50 countries. This intensive cooperation with clients throughout the world has taught us that no matter what business you’re in, reliable, top quality data is essential for success.
The Professional Services experts from atrify are happy to help you put together a comprehensive data dictionary for your products. One of the first steps here is to form a foundation from a basic assessment of your product data. In a later step we work with your specialists to carry out an attribute analysis and get the data requirements represented in a data dictionary. Together we will ensure a seamless transition to EUDAMED – click by click.

Learn more about our EUDAMED solution.