Exemplary How To Write Clinical Evaluation Report
Payers including Medicare and insurance companies dont care what order you write the information in your reportas long as you include it all.
How to write clinical evaluation report. A list of possible elements to include in your CER is as follows. 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. First consider strengths which include positive attributes key accomplishments and areas of specialty.
Step 3 requires that. Step 2 entails review of the data collected for applicability relevance significance and quality. Be sure to know what information each payer requires.
The CER will form part of. The aim of this course is to better understand what is involved in writing a CER to Medical Device Regulation MDR 2017745. The report should answer the evaluation question in an unbiased way and be written in an accessible format for your intended audience.
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. Concise physical and technical device description and intended application. Under the new EU MDR which come into place in May 2020 the emphasis on CERs has greatly increased.
Clinical evaluation and data types. The guideline determining the structure and content of the CER is MEDDEV 271 Rev. 3 and pertains to the creation of clinical evaluation reports which are defined as the assessment and analysis of clinical data pertaining to a medical device in order to verify the clinical safety and performance of the device It is this key feature of the regulatory process that serves as the basis for this.
A clinical evaluation report CER is an important technical document required for a medical device to be CE marked and therefore sold in Europe. Perform a clinical study and summarize the results 2. Summary of clinical data and review.