EUDAMED launch postponed to 2022. MDR start date now September 2021

30 Oct 2019

Always 100 percent. A value that hovers above everything else in the healthcare sector. After all, human lives are at stake here. The regulations for manufacturers are therefore tightly meshed, but also enormously complex. But anyone who works in this industry knows that the end result must be 100 percent. In addition to the high demands placed on the products themselves, data recipients such as hospitals, health insurance companies, registers and authorities place further demands on manufacturers. The communication of master data is a central point here. Maximum data quality and transparency are required here. For example, when it comes to the following requirements:

  • Supply chain regulations
  • Target market-specific requirements for data
  • MDR, EUDAMED, NHS, US AID, FDA
  • Independent presentation in the German target market profile (independent of regulations) 
  • Recipient-specific xls overviews of individual data recipients

What requirements do you face as a manufacturer and data supplier?

On the one hand, there are the external requirements of hospitals & co. On the other hand, there is a large amount of internal product data that needs to be compared with the requirements. A major challenge - especially if the required information is not even available internally! For manufacturers, this means that the product data must be structured and constantly updated so that it is available for the various data recipients. It is also important to communicate the data regularly. And in different formats, in individual volumes and to different data recipients. These can be internal departments, distributors and wholesalers, consumers and patients, authorities and registers as well as hospitals and clinics. It is important that manufacturers notify data recipients promptly of any changes to data. But not only that, because these changes must also be saved in your own system so that the product information is updated and available in a structured manner.

As a manufacturer, how do I find out when requirement profiles have changed? 

It is often a "debt to be collected" that takes time and effort. In order to always be up to date with the latest information, the manufacturer must regularly visit the various websites of its data recipients and search for data models and updates. The more changes and requirements there are, the greater the manual effort required to update the data. 

What solutions are available?

Structure is the be-all and end-all. To be able to work quickly, correctly and without additional effort, the product data must be stored internally in a central data source in a structured manner. What is the best way to do this? How do you create a central location where all data is stored? The prerequisite for this is that every process is transparent and precisely defined internally. It must be precisely defined:

  • which product data is stored by whom, where and how
  • which data is intended for which recipient
  • how the product data is developed in the internal process

Once this is done, data communication with the various stakeholders can proceed smoothly and quickly. If you would like to find out more about this topic, our blog posts
"The Data Dictionary 1×1" and "EUDAMED Data Dictionary" for more information.

Team atrify

Team atrify

Team atrify is all of us at atrify. We understand the problems manufacturers face in data management. Data optimization and internal system integration are our core competencies. We advise and implement the requirements for both commercial and regulatory use of the data in a system.

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