This document discusses the importance and benefits of clinical evaluation for medical devices according to regulatory requirements. It notes that recent directives now require all medical devices to have a clinical evaluation report, not just implantable or class III devices as was previously assumed. Conducting clinical evaluations allows manufacturers to detect and address safety issues early, improves their image and reputation, and ensures regulatory compliance which is necessary for approval and CE marking. It recommends working with I3 Consulting, who provide clinical evaluation services and help clients navigate requirements to ensure adequate evaluation is performed according to guidelines.