Module 16 2024

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Cover Page	1
Course Programme	2
Lecture 1: Where are we with EU-MDR?	5
Lecture 2: Unique Device Identification & Traceability in Healthcare	37
Lecture 3: Post-Market Surveillance Requirements Under the MDR (EU) 2017/745	51
Lecture 4: The role and responsibilities of Approved Bodies and Notified Bodies in vigilance and Post-Market Surveillance	83
Lecture 5: Post-Market Surveillance, Risk Assessment and Corrective/Preventative Action	96
Lecture 6: Understanding of the Periodic Safety Update Report (PSUR) under the MDR	110
Lecture 7: Post Market Clinical Follow-Up	133
Lecture 9: Post Market Surveillance Legal Considerations	146
Lecture 10: Field Safety Corrective Actions - Legal Considerations	163
Case Study	179