>MedDev 2.7/1 Guideline: Equivalence and Risk/Benefit Profile
This gap analysis defined in MEDDEV 2.7/1 revision 4, CE is a “procedure to collect, appraise and analyze clinical data pertaining to a medical device and to evaluate whether there is sufficient clinical evidence to confirm compliance with relevant essential requirements for safety and performance when using the device according to the manufacturer’s Instructions for Use.”
In a series of gap analyses, Criterion Edge will select critical changes from these guidelines and examine them.