As part of the new regulations, clinical evidence has become much more important. Medical device manufacturers must provide sufficient information to demonstrate that their devices are clinically safe and will achieve its intended purpose without subjecting patients to risk.
This information, including any device evaluation or clinical trial, must be presented in a clinical evaluation report. These reports need to follow the format given in MEDDEV 2.7/1 revision 4. A suitably qualified person must write the clinical evaluation reports.
Our medical device regulation consultants have the experience and qualifications necessary to write clinical evaluation reports. We would be happy to provide you with further information on this service.