Clinical Studies on Medical Devices

Regulations such as the Medical Device Regulation (MDR) place high documentation requirements on medical device manufacturers. In assessing and verifying the safety and performance of a medical device, the manufacturer must conduct a clinical evaluation. Clinical evaluation is necessary in order to successfully complete the European conformity assessment procedure for medical devices and obtain CE marking.

As part of this evaluation, clinical data is systematically generated, collected and analyzed. This is often realized through clinical studies, according to the MDR. Only in specific cases this requirement may also be met by referring to studies on a demonstrably similar product from published literature. Based on results out of clinical studies or systematic literature review, the manufacturer of the medical device can assess whether the possible risks of an individual use are in an acceptable relationship to the predicted benefit.

The clinical evaluation is therefore an important part of the documentation and quality management or risk management of a medical device.
According to the MDR, possible acceptance criteria and milestones should already be described when planning clinical trials. Step-by-step planning and a cautious approach are intended to minimize unknown risks, especially in the case of novel medical devices.

Clinical evaluation is a continuous and systematic process that begins before MDR certification and, in accordance with the European Medical Device Regulation 2017/745 (MDR), entails clinical follow-up after a product has been launched on the market (PMCF plan).

The results of the clinical evaluation are documented in the Clinical Evaluation Report (CER). The CER remains up to date through constant observation and evaluation of available data on the medical device. Through continuous post-market surveillance, unrecognized risks can be identified and evaluated after the device has been placed on the market.

CSG has broad experience in the design and conduct of clinical trials (feasibility studies, PMCF, etc.) required for clinical evaluation, as part of study programs and market access strategies.