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Commission confirms availability of EUDAMED modules

  • Posted by: inetika
  • Category: GLOBAL NEWS

The European Commission website page devoted to EUDAMED has now been updated to provide information on when the first modules of the system needed to support the new device regulations will be available for the various actors to use on a voluntary basis.

The webpage explains that:

  • The development and implementation of EUDAMED is a high priority for the Commission.
  • We have pledged, in agreement with the MDCG, to gradually make the different modules available as soon as they are functional.
  • We will make the module on actor registration available first, deploying it by March 2021 at the latest.
  • We will make the module on UDI/device registration (second module) and the module on certificates and notified bodies (third module) available by May 2021. The remaining modules will become available afterwards as soon as they are functional.

There is no indication yet when the remaining modules on vigilance, market surveillance and clinical investigations will become available.

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