All medical devices require a clinical evaluation and a clinical investigation in order to prove that the product is safe to be used by the intended users and that it achieves what the manufacturer claims the device was designed for, i.e. the device’s intended use.
This document was designed to provide guidance to manufacturers of medical devices to help them understand the requirements for clinical evaluation and investigation of their product(s) under the new EU Medical Device Regulation 2017/745.
A preview of the Clinical Evaluation Guidance Document is available here:
You may purchase the full document in convenient Microsoft Word format including instructions for use below.