Clinical evaluation: assess safety, performance and benefits.
Clinical evaluation is an important building block on the way to MDR certification
Clinical evaluation is indispensable to assess and ensure the safety, performance and benefits of a medical device. For this purpose, data is systematically generated, collected, analyzed and evaluated accordingly. On the basis of these results, the manufacturer of the medical device can assess whether the potential risks of use are in reasonable proportion to the predicted benefits.
Clinical evaluation is thus an important part of the documentation, quality management and risk management of a medical device. Regulations such as the Medical Device Regulation (MDR) place high demands on the documentation and manufacturers of medical devices. As part of this documentation, the clinical evaluation is required to successfully complete the European conformity assessment procedure for medical devices and to obtain the CE marking.
What criteria must the clinical evaluation meet
During the clinical evaluation, clinical data are collected from different sources, such as published clinical trials or studies conducted with similar approved products (equivalence principle).
Clinical evaluation format
The guideline MEDDEV 2.7/1 of the European Commission is decisive for the format of the clinical evaluation.
Clinical evaluation is a continuous and systematic process that begins before MDR certification is obtained and includes clinical follow-up after a product is launched on the market, in accordance with the legally mandated European Medical Device Regulation (MDR) 2017/745.
According to the MDR, possible acceptance criteria and milestones should already be described during the planning of clinical trials. Step-by-step planning and a cautious approach are intended to minimize unknown risks, especially with new products and processes.
The result of the clinical evaluation is the Clinical Evaluation Report (CER), which is kept up to date by constant observation and evaluation of available data for the medical device. This allows unidentified post-marketing risks to be identified and re-evaluated.
The manufacturer can use current data to weight the justifiability of risks and any side effects that may occur, evaluate long-term safety, efficacy and interactions with other products. Waiver of clinical data is possible only in exceptional cases, and clinical evaluation is mandatory even in these cases.
How Medicoforum supports you
Contact us if you need advice or support in preparing your clinical evaluation under MDR or associated components of your medical device documentation. We can support and advise you with our expertise!