Naidoo S. Clinical Evaluations for Medical Devices

Arcler Press, 2022. — 203 p.Being a medical device manufacturer involves more than just manufacturing the device itself. It is also the manufacturer's 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 as 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 to 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.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).