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EUDAMED just kicked off! Ready? Set? Or Need to get started?

EUDAMED, the European Database for Medical Devices and In-Vitro Diagnostics, has been planned to ensure the increase in transparency for medical devices and to improve coordination between member states.

The EUDAMED IT system consists of a total of six modules. These different modules will be made available on a gradual basis as soon as they become functional. The first module to be rolled out is for “Actor Registration Module” which is key to accessing and using EUDAMED. Learn how to proceed with actor and user registration and management, data to be stored, and the general validation process to receive an SRN.

Key Take-Aways:

  • Understanding the regulations (EU) 2017/745 for medical devices and (EU) 2017/746 for in-vitro diagnostics
  • Who are the ACTOR’s and what are their roles in EUDAMED
  • What is meant by SRN and how to decode the SRN
  • Understand the Actor registration process
  • Person Responsible for Regulatory Compliance (PRR) and their responsibilities in EUDAMED