How to Write a Clinical Evaluation Report
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| Level: |
Advanced
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Area: |
Medical Devices
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| Code: |
MDA2a
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Duration: |
03:30:00
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| Workshop profile: |
| This workshop is intended for medical writers with regulatory writing experience who are either interested in working with medical devices or who already work with medical devices and are involved in preparing clinical evaluation reports (CERs). Familiarity with the medical device regulation (MDR) 2017/745 and the CER writing guideline MEDDEV 2.7/1 rev. 4 is desirable. Prior attendance at the Introduction to Writing for Medical Devices or From Pharma to Medical Devices workshops would be helpful but is not essential. |
| Objective: |
| The aim of this workshop is to understand how to write a CER, in particular for higher risk medical devices. Participants will learn how to prepare a CER to MDR standards with reference to the MEDDEV 2.7/1 rev. 4 guideline. Note that conducting a clinical literature review, defining the state of the art and post-market clinical follow-up (PMCF) are only briefly presented in this CER workshop as they are the subject of separate workshops. |
| Content: |
| The workshop will explain the following:
Introduction to medical device regulation and market approval process;
Clinical evaluation process;
Clinical evaluation plan;
Clinical evaluation report;
Device under evaluation;
Literature review – current knowledge, state of the art, clinical literature;
Preclinical and clinical data;
Clinical investigations;
Claims
Risk assessment – benefit/risk;
Post-market surveillance (PMS) including PMCF.
The workshop will include group exercises and discussions. |
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