The European Commission (EC) confirms the launch of Eudamed will be delayed until May 2022.
Reports were confirmed by the EC from Brussels last week. Sophie Dupin De Saint-Cyr, press officer for internal market, industry, entrepreneurship commented: "The Commission concluded that it will only be possible to make Eudamed operational once the entire system and its different modules have achieved full functionality and have been subject to an independent audit.”
Eudamed is a database that will be used to monitor both the safety and performance of devices. It’s new launch date coincides with the implementation date for the In Vitro Diagnostic Regulation, which will be enforced on 26th May 2022. However, the EU Medical Device Regulation (MDR) will still take effect on 26th May 2020.
The database will contain different modules on actors, unique device identifiers, devices, notified bodies and certificates, vigilance, clinical investigations, performance studies and market surveillance. The aim of the database is to improve the transparency and coordination of information of medical devices on the EU market.
Now the implementation date has been pushed back, companies with MDR Eudamed projects will have more time to prepare their systems and populate the database. Additionally, the Eudamed project is expensive and as many companies are thought to have underestimated the size and complexity of the required projects this extension will be welcome. The EC will also be able to use this time to finish the MDR Eudamed modules which are currently incomplete.
"It's a nice surprise for all of us," commented Richard Houilihan, CEO of Eudamed. "Hopefully, the industry won't waste time."
Houlihan advised industry to "view this delay as a gift."
