Day2

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

  • Identification of the activities
  • Role in the quality management system
  • Annex IX documentation
  • Notified body obligations

Part B – Premarket Activities

  • Clinical/performance evaluation (plan and report)
  • Risk management (plan and file)
  • Benefit-risk determination
  • Indicators and thresholds
  • Exercise B1 – Indicator and Threshold Analysis

10:30 a.m. – 10:45 a.m.

Morning Break

10:45 a.m. – 12:00 p.m.

Part C – Postmarket Surveillance (PMS)

  • PMS plan
  • PMS report
  • Periodic safety update report (PSUR)
  • Linkage to other activities
  • Exercise C1 – Developing Elements of the PMS Plan
  • Exercise C2 – Creating and Updating the PSUR

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)

  • PMCF/ Postmarket performance follow-up (PMPF) plan
  • PMCF/PMPF evaluation report
  • Linkage to other activities
  • Exercise D1 – Developing Elements of the PMCF/PMPF Plan
  • Exercise D2 – Preparing the PMCF/PMPF Evaluation Report

Part E – Summary of Safety and Clinical Performance (SSCP)

  • Application
  • Content
  • Distribution
  • Exercise E1 – Preparing an SSCP

2:15 p.m. – 2:30 p.m.

Afternoon Break

2:30 p.m. – 4:30 p.m.

Part F – Vigilance & Trend Analysis

  • Field safety corrective action
  • Incident classification
  • Reporting serious incidents
  • Trend reporting (non-serious incidents)
  • Exercise F1 – Classifying Incidents

Part G – Statistically Significant Increase

  • The concept of statistical significance
  • Trend reporting plan
  • Calculating a trend line
  • Using Excel to test for statistical significance
  • Using an ISO 14971:2019 risk matrix
  • Exercise G1 – Developing the Trend Reporting Plan

4:30 p.m.

Workshop Completed

 

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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

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