Identification, collection, appraisal, and analysis of the medical device’s pre-market and post-market clinical data in order to demonstrate MDR GSPR compliance.
- A clinical evaluation report should be compiled to document the clinical evaluation with a specified time schedule.
- It should provide enough detail for understanding the search criteria adopted, data that are available, all assumptions made, and all conclusions reached.
- The contents of the clinical evaluation report are relevant to the medical devices which should vary according to the nature and history of the device under evaluation.
The description of the device under evaluation and a clinical evaluation plan should be provided. Scope of the clinical evaluation should include the identification of devices covered by this clinical evaluation report, products, models, sizes, software versions, accessories, whether it is on the market, since when, in what regions, history of the device, in case of update in the plan including date of past modifications with reasons and description, sales volumes, changes since the last report, identification of the sections of the clinical evaluation report that are concerned with the new information and have been modified should be detailed.