On the 10th of October the International Medical Device Regulators Forum (IMDRF) released three Clinical Guidelines: clinical evidence, clinical evaluation and clinical investigation.
The Clinical evidence document consists out of 8 pages and intents to:
introduce the concepts of clinical evaluation and clinical evidence;
- examine the relationship between clinical investigation, clinical data, clinical evaluation and clinical evidence: and serve as guidance to all those involved in the generation, compilation and review of clinical evidence sufficient to support the marketing of medical devices (regulatory authorities, conformity assessment bodies, manufacturers of medical devices and their associated industry groups).
The final document of the Clinical evaluation intents to provide manufacturers with guidance on how to conduct and document the clinical evaluation of a medical device as part of the conformity assessment procedure prior to placing a medical device on the market as well as to support its ongoing marketing. It is also intended to provide guidance to regulators and other stakeholders when assessing clinical evidence provided by manufacturers.
Last but not least, the clinical investigation guidance is provided with the purpose of:
when a clinical investigation should be undertaken for a medical device to demonstrate compliance with the relevant Essential Principles (see IMDRF/GRRP WG/N47 FINAL:2018 “Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices”); and
the general principles of clinical investigation involving medical devices
For all the documents, please click here.
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