Clinical Evaluation Reports How To Leverage Published Data

If you are not a medical device company or do not have devices on the market in Europe, then comprehensive clinical evaluation reports may be a new concept. But make no mistake, the use of these powerful assessments extends beyond just Europe and just medical devices. As regulators, payers and the public increases emphasis on clinical data to support medical devices, this familiar format will be useful for other applications. Presenting clinical data in an unbiased format has been successful for biologic devices in other international geographies. Executive summaries of these reports may be leveraged to demonstrate the similarity of new devices to those currently with payer coverage to gain reimbursement.