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Database for New European IVD, Medical Device Regulations Delayed to 2022

NEW YORK – Technical challenges have forced the European Commission to move the launch of the European database on medical devices, or Eudamed, until May 2022, a delay of roughly two years.

The Eudamed database is an integral part of the new Medical Device and In Vitro Diagnostic Regulations, with which manufacturers are supposed to be compliant by May 2020 and May 2022, respectively. It supports the gathering of data about devices on the market, their conformity assessments by notified bodies, performance study data, and post-market surveillance information.

The upgraded database was supposed to go live no later than March 2020, but according to a statement published online, that is no longer the case.

According to the statement, the Commission continues to work on implementing the database, but concluded recently 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."

Because of this, it decided to launch the database when the new IVD Regulation comes into force in May 2022. The date of application of the MDR, the Commission noted, remains May 2020, and medical device manufacturers are expected to collect the data necessary that can be entered into Eudamed once it becomes available.

Questions around the availability of Eudamed have worried test makers for months. In July, Oliver Bisazza, director of regulations and industry policy at MedTech Europe, a Brussels-based European trade association that represents IVD and medical device manufacturers, said that the community was concerned about the approaching March 2020 deadline.

"In general, and ideally, manufacturers need at least 18 months of lead time between the finalization of Eudamed specifications and the date at which they legally must start interacting with the database," Bisazza said. "This is leading to widespread concerns of a crunch time."