In recent years, clinical reports have become much more important. Manufacturers of medical devices must provide information to prove that their medical device is safe, this can be found in a clinical evaluation report. This applies to all medical devices regardless of their classification. Here we will outline how to prepare for a clinical evaluation report.
First, you must research clinical data and assess the quality of the data, then you should form conclusions on the data researched and input it into your report. In your clinical evaluation report you must include –
- Device manufacturer and name
- Description of application
- Intended therapeutic claims
- Evaluation of data
- Summary of clinical data
- Review of clinical data
- Performance and safety assessment
Your clinical evaluation report must be updated regularly and any necessary changes must be recorded, in order to remain compliant.
At Patient Guard, our team of highly trained professionals are always on hand to help when you’re struggling with your clinical evaluation report. We follow the required format of MEDDEV 2.7/1 revision 4. Contact us for more information.