Module 12 Presentations

29/01/2024

Objective of the changes

• Strengthen the regulatory requirements across European Union • Improve transparency with more reporting data • Improve traceability

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Example of changes

• Technical File structure defined • Increase of clinical requirements

• The implementation of UDI (Unique Device Identification) and the EUDAMED (European Database for Medical Devices) • Increase of Post-marketing Surveillance

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