Clinical evaluations have several important differences from Post Market Surveillance:

1. In many jurisdictions they are a prerequisite for market access submissions
2. They are compiled and evaluated by third parties
3. Emphasis is on clinical performance and safety
4. They are much more in-depth than a Post Market Surveillance report
5. The reports are mandatory under the Essential Requirements (6a)
6. A clinical study may be required to demonstrate compliance

Regulatory agencies and notified bodies would expect Clinical Evaluations for devices in risk classifications 1 to 2a to typically be about 40 pages in length. For devices in risk classifications 2b and 3 the clinical evaluation should be very comprehensive and 300 page dossiers would not be unusual.