Textbook in PDF format

Being a medical device manufacturer involves more than just manufacturing of the device itself. It is also the manufacturers responsibility to ensure adequate research is done on the device so that it can be safely used. Clinical evidence is often collected throughout the entire life cycle of a medical device and is often an ongoing process. The process starts during the design and development of the device to show safety and efficacy and is often updated even after the device is on the market. This evidence is often compiled in a Clinical Evaluation Report and presents itself a chapter of the device technical file. As the medical industry continues to evolve, so does the complexity of clinical data needed during the regulatory approval process. This volume provides an introduction into the basic concepts of clinical evaluation report writing. Important concepts such as how to conduct a literature review, claiming equivalence and when to update your clinical reports are covered.
Introduction
Preface
What Is a Clinical Evaluation Report (CER)?
Understanding MEDDEV 2.7/1 (Revision 04) in Greater Detail: MEDDEV 2.7/1 (Rev 04) – Clinical Evaluation: A Guide for Manufacturers and Notified Bodies Under Directives 93/42/EEC and 90/385/EEC
Essential Requirements (ERs) of Medical Devices (Under the MDD 93/42 EEC)
General Safety and Performance Requirements (GSPRs) of Medical Devices (Under the MDR 2017/745)
Claiming Equivalence Between Medical Devices
MDCG 2020-5: Clinical Evaluation – Equivalence: A Guide for Manufacturers and Notified Bodies
Differences in Technical, Biological, and Chemical Characteristics
Demonstration of Equivalence
Use of Data From Similar Devices
How to Conduct a Literature Review?
When to Update Your CER?
What Is a Clinical Evaluation Plan?
Post-market Clinical Follow-Up (PMCF)
Appendices
Bibliography
Index