Deep Dive: Clinical Evaluation Reports

Categories: Deep Dive, EU
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About Course

We are currently revising this course. The updated version is expected in November 2024.

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A Deep Dive into the clincial evaluation process under the EU Medical Device Regulations 2017/745.

The requirements for clinical evalaution in the EU have become increasingly stringent under the new MDR. It is a process which overlaps with may other regualtory aspects including risk management and post-market surveillance, and is critical in demonstrating the device can perform safely and effectively. We learn how to plan and perform clinical evaluation, with the goal of developing a obust Clinical Evaluation Report which will withstand Notified Body scrutiny.

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What Will You Learn?

  • Understand the regulatory requirements for Clinical Evaluation Reports (CERs) under EU MDR 2017/745, including key concepts like clinical evidence, state of the art, and equivalence.
  • Develop a comprehensive Clinical Evaluation Plan (CEP) and conduct systematic literature reviews to gather and appraise clinical data.
  • Analyze and synthesize clinical data to demonstrate the safety and performance of medical devices, and effectively address data gaps and uncertainties
  • Prepare a compliant CER, structured to meet regulatory expectations, and manage interactions with Notified Bodies and Competent Authorities.
  • Implement post-market clinical follow-up (PMCF) activities and maintain the CER throughout the product lifecycle to ensure ongoing regulatory compliance.

Course Content

Introduction and Background
Welcome to the course! Before we begin, let's cover some of the essential background needed to get the most out of this course.

  • Welcome!
  • Instructor Tips
  • Course Scope

Introduction to Clinical Evaluation and EU MDR 2017/745

Key Requirements for Clinical Evaluation Reports (CERs)

Planning the Clinical Evaluation Process

Conducting a Systematic Literature Review

Analyzing Clinical Data and Evidence

Writing the Clinical Evaluation Report (CER)

Device Classification and Specific Requirements

Preparing for CER Submission and Review

Post-Market Clinical Follow-up (PMCF) and CER Maintenance

Case Studies and Best Practices

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