Clinical Evaluation Report Medical Device Template

In china all medical devices are divided into three classes by their risk levels.

Clinical evaluation report medical device template. A cer consists of analyzed clinical data that was collected either from a clinical investigation of your device or the results of other studies on substantially equivalent devices. Pritchard clinical evaluation reports the clinical evaluation report cer is the document containing this information and is intended for review by the notified body nb who assess medical devices for initial or renewal of market approval the ce mark. To begin with as the name indicates a clinical evaluation report cer is a file that you prepare in order to document data and results of the clinical evaluation of your medical device. A clinical evaluation report cer documents the conclusions of a clinical evaluation of your medical device.

Letter template v01 2016 06 30. If you plan to sell your medical devices in europe you must produce and maintain a clinical evaluation report cer that complies with meddev 2 7 1 revision 4 and the mdd or mdr 2017 745. The cer and the clinical data are used together to prove the conformity of the medical device to the general safety and performance requirements. You will get a number of useful information that will come handy when you prepare a report yourself.

Iec62366 medical devices application of usability engineering to medical devices. Letter template v01 2016 06 30. This lack of clarity has led to varying. Template clinical evaluation report v03 2017 0516.

Essential requirement 6a the clinical evaluation report cer is required for all medical devices that are ce marked. A clinical evaluation report cer for medical device is a document that contains the conclusions of the clinical evaluation performed on the medical device based on all relevant clinical data available. Clinical evaluation report cer what is it. The given report sample provides a detailed guide on the concept and purpose of clinical evaluation and an evaluation report.

Go through the given sample for getting a thorough knowledge of the various aspects of such evaluation reports along with its format. The cer will form part of the technical file or for class iii. Up until the medical device directive mdd was modified in 2010 i e 2007 47 ec only high risk devices required a clinical evaluation report. Every medical device sold into europe irrespective of its classification must have an up to date clinical evaluation report cer as part of its technical file.

Your cer documents the result of the clinical evaluation of your device. Evaluation and testing within a risk management process.