MEDDEV Guidelines for Clinical Evaluation EU MDR
During the conformity assessment, the manufacturer must submit the complete information material (labelling, IFU (Instructions for Use), any promotional materials and other relevant documents), Clinical evaluation plan & report with the available clinical data, which includes (General Safety and Performance Requirements) GSPR, intended target groups and purpose, qualitative and quantitative aspects of clinical safety, performance procedures and other risk factors involved. The manufacturer m...
