8:00 a.m. – 8:30 a.m. |
Registration/Continental Breakfast |
8:30 a.m. – 10:30 a.m. |
Part A – Overview of the Postmarket Activities
Part B – Premarket Activities
|
10:30 a.m. – 10:45 a.m. |
Morning Break |
10:45 a.m. – 12:00 p.m. |
Part C – Postmarket Surveillance (PMS)
|
12:00 p.m. – 1:00 p.m. |
Lunch Break |
1:00 p.m. – 2:15 p.m. |
Part D – Postmarket Clinical Follow-up (PMCF)
Part E – Summary of Safety and Clinical Performance (SSCP)
|
2:15 p.m. – 2:30 p.m. |
Afternoon Break |
2:30 p.m. – 4:30 p.m. |
Part F – Vigilance & Trend Analysis
Part G – Statistically Significant Increase
|
4:30 p.m. |
Workshop Completed |
Description of the Exercises
Course 2 - Postmarket Activities in the EU-MDR/IVDR – A Detailed Analysis
Exercise B1 – Indicator and Threshold Analysis
Participants use a hypothetical device and information from clinical/performance evaluation and risk management to set indicators and thresholds to help make the benefit-risk determination.
Exercise C1 – Developing Elements of the PMS Plan
Participants use a hypothetical device to develop effective and appropriate methods and tools to investigate complaints.
Exercise C2 – Creating and Updating the PSUR
Participants use a hypothetical device to determine the volume of sales of the device, estimate the size and other characteristics of the population using the device and, where practicable, the usage frequency of the device.
Exercise D1 – Developing Elements of the PMCF/PMPF Plan
Participants use a hypothetical device to determine and justify methods and procedures.
Exercise D2 – Preparing the PMCF/PMPF Evaluation Report
Participants, using a hypothetical device, analyze PMCF findings.
Exercise E1 – Preparing an SSCP
Participants, using a hypothetical device, identify the elements to include in the SSCP.
Exercise F1 – Classifying Incidents
Participants use complaints and other post-market information to apply the elements of the incident classification system.
Exercise G1 – Developing the Trend Reporting Plan
Using a hypothetical device, participants plan the methods to determine a statistically significant increase in the frequency of incidents, a statistically significant increase in the severity of incidents, and the observation period.
Course I | Course II | Course III