Clinical Evaluation Upgrade to MDR


Is your Clinical Evaluation ready for the MDR? Discover Meditrial e-learning and avoid delays for market access. Meditrial will guide you with easy steps. Learn at your own pace and reach your goals!
After the course, you can take a brief test to receive your certification. Enjoy!

  • Course Type: Video Lecture
  • Language: English
  • Level: Beginner
  • Session: year 2020
  • Time: 0 - 1 Hour
  • Moodle ID: 152

Course Breakdown

Section Time
Introduction 00:05:43
Regulatory References 00:02:36
General Safety and Performance Requirements 00:04:25
Expert Panel and Relevant Evidence 00:03:58
Clinical Investigations and Equivalence 00:04:54
Clinical Evaluation Updates and Clinical Evaluation Report 00:06:08
Clinical Evaluation Plan Content 00:04:52
Criteria for Equivalence and Results 00:01:38
Consultation and Scrutiny 00:06:04
MDR Periodic Deliverables 00:01:31

Exam and Certifications

  • Final Test – Clinical Evaluation Upgrade to MDR
  • Certification


What I will learn?

  • Clinical evaluation regulatory framework
  • Overview of Article 61 of MDR
  • General Safety and Performance Requirements
  • How to conduct Clinical evaluation: Step by Step
  • Notified Body Clinical Evaluation Assessment Report (CEAR)
  • What are your periodic deliverables?

Skills I will gain

  • Understand the clinical evaluation process
  • Learn about the new GSPR and their relevance for medical devices assessment
  • Determine which data you need to support the assessment of your device (clinical investigation, literature review, equivalence)
  • Assist your organization in setting a strategy for a successful clinical evaluation


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