Clinical Evaluation for medical devices

Clinical evaluation is the evidence that a medical device delivers its intended benefit and that its risks are acceptable. Under the MDR it is mandatory for every device regardless of class, and it does not end with approval: post-market clinical follow-up keeps it continuously updated.

What changed fundamentally with the MDR is the equivalence route. Previously a reference to a similar device often sufficed; today equivalence must be demonstrated technically, biologically and clinically, and for implantable devices and class III a contract granting access to the comparator's technical documentation is generally required. From a third-party manufacturer that is practically unobtainable — which is why own clinical data are needed more often than before.

The providers listed here cover different parts: literature search and appraisal, preparation of the clinical evaluation plan and report, planning and conduct of clinical investigations to ISO 14155, biostatistics, and analysis of follow-up data. Planning early allows post-market data to be collected in a form that is usable later — retrofitting that rarely works.