Description: The most common gaps in MDR technical documentation reviewed by Notified Bodies continue to be in clinical evaluation. There have been a number of webinars and presentations on clinical evaluation requirements, however, manufacturers are still struggling to apply the requirements in the actual clinical evaluation plan and report.
This 1-day workshop will provide participants with hands-on experience on how to write CEPs and CERs to the requirements of the EU-MDR. Specific areas of focus will be on common questions from Notified Bodies such as:
1) No meaningful or measurable safety and performance benchmarks/endpoints and/or acceptance criteria 2) PMCF activities are not aligned, clinically acceptable, or sufficiently rigorous to address acknowledged gaps in clinical knowledge 3) The IFU, CER, and Risk management documentation are not consistent This workshop will be based upon an example, fictional device. Workshop leaders will provide participants with key requirements and instructions on how to meet those requirements. Participants will then have an opportunity to practice applying those requirements in small working groups
Agenda
7:00-8:00 am Registration and Continental Breakfast 8:00-8:30 am Welcome and Workshop Introduction 8:30-9:15 am Safety and Performance Endpoints, Benefits and Claims 9:15-10:00 am Case Study Exercise 10:00-10:30 am Refreshment Break 10:30-11:15 am Clinical Strategy 11:15 am-12:00 pm Case Study Exercise 12:00-1:00 pm Lunch 1:00-1:30 pm Literature Search 1:30-2:00 pm Appraisal and Analysis 2:00-2:30 pm Case Study Exercise
2:30-3:00 pm Refreshment Break 3:00-3:30 pm Sufficient Clinical Evidence and PMCF 3:30 - 4:30 Case Study Exercise 4:30-5:00 pm Final Thoughts and Discussion 5:00 pm Adjourn
Learning Objectives:
Identify clinical performance and safety requirements, claims, and benefits
Select and define a clinical strategy
Ensure there is sufficient clinical data, and have appropriate plans in place to address any identified gaps in the data