Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

EUDAMED

 Already exists as a communication tool used by competent authorities for CE marking ● Used to upload registrations of manufacturers and Authorised Representatives ● Used for notification of certification issued, modified withdrawn or refused by Notified Bodies ● Vigilance data

The Organisation for Professionals in Regulatory Affairs

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• Data base set up by EU Commission

• Has been in operation since 2011

• Not currently accessible by public

• Used by Competent Authorities only

The Organisation for Professionals in Regulatory Affairs

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