>MedDev 2.7/1 Guideline: More Clinical Evaluations?
This report will focus on critical modifications in the areas of clinical evaluation (CE) updates and post-market surveillance (PMS) from the revised CE MEDDEV guideline. The objectives of this report are to explain the modifications and create a plan for compliance to them. General-ly, these changes suggest the need to submit more CE reports (CERs) to the regulatory authorities, however, strategies will be discussed for managing the increased requirements.