Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

Warning!!!!

 The points presented are a personal view and do not represent those of any company or organisation.

The Organisation for Professionals in Regulatory Affairs

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EU Registration Process

• Manufacturer completes conformity assessment

• Manufacturer or Authorised Representative will upload information and conformity assessment proof to EUDAMED • UDI-DI • Links to Notified Body certification

The Organisation for Professionals in Regulatory Affairs

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