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It’s official: Eudamed delayed until 2022 for both MDR and IVDR

  • Posted by: inetika
  • Category: GLOBAL NEWS

The European Commission has now concluded the obvious: that the Eudamed database for medical device information required by the Medical Devices Regulation (MDR, 2017/745) and the In Vitro Diagnostics Regulation (IVDR, 2017/746) will not be fully operational by the initial target date of March 2020.

The Commission has decided against introducing Eudamed in a modular manner, even though some modules are apparently already functional, because it is believed that such an approach would cause significantly more confusion than if introduction is delayed for all modules. The database is now targetted to be launched simultaneously for both medical devices and in-vitro diagnostics together in May 2022.

This two-year delay effectively means that device economic operators can postpone the entering of data until, at the latest, 18 months after the Commission publishes a statement that Eudamed is fully functional.

The delay in Eudamed availability is reported on this page of the Commission website.