Registry of Medical Devices (RZPRO)

RZPRO – agendas provisionally processed via RZPRO

Due to the delayed launch of the fully operational EUDAMED database, the RZPRO will continue to be used for the following scope of activities.

This will apply to:

  •  Notifications of manufacturers, importers and authorised representatives
  • Registration of medical device by manufacturers, importers and authorized representatives
  • Clinical investigations and monitoring-related agenda (except for other clinical investigations pursuant to Article 82 of the MDR)
  • Agenda related to the authorisation and monitoring of performance studies.
  • Application for free sale certificates
  • Field safety notice

MANUALS