Module 16 2022

05/09/2022

EUDAMED & Databases

• Market Surveillance • Summaries of the results of any surveillance activities • Final inspection reports • Information in relation to devices presenting an unacceptable risk to health and safety • Information in relation to non-compliance of products • Information to the preventative health protection measures • Summaries of the results of the reviews and assessments of the Members States

The Organisation for Professionals in Regulatory Affairs

25

• EUDAMED Timings • Actor Registrations – Now (voluntary) • UDI – Now (voluntary) • Certificates – Now • Clinical – 2024 • Vigilance – 2024 • Market Surveillance – 2024 • Public – Now • Fully functional EUDAMED system – 2024 EUDAMED & Databases

The Organisation for Professionals in Regulatory Affairs

26

13