It's official: EC confirms 2-year Eudamed delay

Dive Brief: The European Commission is delaying the launch of Eudamed until May 2022, a […]

Dive Brief:

  • The European Commission is delaying the launch of Eudamed until May 2022, a spokesperson for the EC told MedTech Dive in an email Wednesday. Eudamed is the database which will be used to monitor the safety and performance of devices and is part of the EU’s broader overhaul of device regulation.
  • The new launch date for Eudamed coincides with the implementation date for the In Vitro Diagnostic Regulation, set to take effect May 26, 2022.
  • The delay will not extend the effective date of the Medical Device Regulation, which remains at May 26, 2020.

Dive Insight:

The Commission confirmed the reports out of Brussels last week of a delay, which had the device industry buzzing in the days since.
“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,” Sophie Dupin De Saint-Cyr, press officer for internal market, industry, entrepreneurship and SMEs & regional policy, told MedTech Dive.
The database is intended to improve the transparency and coordination of information of medical devices on the EU market. It will contain different modules on actors, UDI and devices, notified bodies and certificates, vigilance, clinical investigations, performance studies and market surveillance.
The delay will give companies with MDR Eudamed projects more time to prepare their systems and populate the database. It also gives additional time for the EC to finish the MDR Eudamed modules, not all of which are ready yet.
“It’s a nice surprise for all of us,” Richard Houilihan of Eudamed Ltd. in Brussels told MedTech Dive in an email. “Hopefully, the industry won’t waste time.”
The Eudamed project is expensive for companies in terms of time and resources, and it’s particularly challenging in terms of IT resources. Many companies have underestimated the size and complexity of the required projects, Houlihan said in a social media posting.
Houlihan advised industry to “view this delay as a gift.”

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