Eudamed, the European Unique Device Identification (UDI) database, is a crucial element for compliance with the EU Medical Devices Regulation (MDR) and the EU In Vitro Diagnostics Regulation (IVDR). It is expected to launch its various modules over the next few months. The Actor module, which allows companies to register, will be released in December 2020, while the UDI and Certificates modules are scheduled for May 2021, before full production is reached in 2022.

Based on my experience working with a significant number of device manufacturers who tested the previous Eudamed ‘playgrounds’, I’m happy to share some tips on becoming compliant with Eudamed requirements.

First, you learn by doing. In this case, that means testing early. Over a year of testing with Eudamed has revealed just how detailed registering UDIs can be – even for manufacturers experienced with the Global Unique Device Identification Database (Gudid). Testing early allows companies to identify issues and, most importantly, gives them time to make the needed corrections.

Second, the devil is in the detail. Manufacturers’ internal systems are missing nearly 60% of the information required for Eudamed. Companies usually do not discover this until they use the database. There is a clear gap in Eudamed documentation related to quality. This means that merely implementing what’s available in the documentation only gets you halfway there. Only through a full testing process do manufacturers get a complete compliance picture for their products.

Third, I understand that every company is unique, and you will need time to discover and address your own challenges. However, it is never too soon to understand the submission process and quality requirements of Eudamed by submitting items to the test environment.

You may find that you need only minor adjustments that can be addressed quickly or that you need major system and data improvements that take up to a year to implement. Past success with other UDI initiatives such as the Gudid is no guarantee of success with Eudamed. All manufacturers should be taking full advantage of the period from May 2021 when the registration module will be made available for voluntary use before the database will reach its full functionality in 2022.

I have one last piece of advice: your strategy to comply with MDR and Eudamed needs to be part of an overall global UDI compliance strategy. It also has to address related ‘UDI data’ needs to provide MDR compliant data requested by hospitals and Group Purchasing Organisations (GPOs) throughout the EU and neighbouring countries such as Switzerland. Here again, testing will ensure data shared with trading partners are indeed MDR compliant.

Time is always shorter than you think and the Eudamed learning curve is steep. Experience teaches that MDR and Eudamed are complex and a challenge for all organisations. However, it is achievable with the right strategy, community engagement, and partners. Together, we can achieve the ultimate goal of the MDR: increased patient safety.