As part of the pre-market obligations for medical devices, the clinical approval constitutes a highly cost-intensive and time-consuming process. In-depth clinical evidence on the safety and performance of a medical device as well as its positive risk-benefit ratio must be yielded and presented within the clinical evaluation. Clinical evaluations based on data on similar products that has been published and made publicly available are less and less often acknowledged. The demands made on the quality of clinical data as well as the comparability with one's own medical device have tremendously increased since the MEDDEV 2.7/1 rev. 4 was introduced. In times past clinical studies constituted an exception for the majority of medical devices to be approved, in future they will be required far more often. Also the request for Post Market Clinical Follow Up Studies will increase, addressing indication related technicalities or securing performance demands.
Performing clinical investigations demands a well-established network and detailed knowledge on the actual realisation:
Which design and sites of study are best suited for your defined goals? How many study participants are needed? Which endpoints does the clinical study have? These questions will be answered during thorough study planning and preparation. Project management, monitoring, data management and statistics are only a few of the several tasks to be accomplished.