3. Clinical evaluation is much more demanding
EU-MDR-compliant clinical evaluation by a clinical evaluator
To be beneficial to patients, medical devices must be effective, with adequate clinical effect levels. At the same time, they should expose patients to the least possible risk. In addition to technical safety and performance, manufacturers of medical devices must be able to prove clinical efficacy and effect size, burden and risks as well as the acceptability of the benefit / risk ratio by a clinical evaluation of their products. Clinical evaluation may require clinical trials with patients.
According to the new EU MDR, this proof of the clinical effectiveness of a medical device and of patient protection is generally provided by a clinical evaluator, namely by means of a specialist clinical evaluation of medical devices. More often than before, a clinical trial in accordance with EN ISO 14155 may be required. At the same time, the manufacturer must submit a clinical development plan. A waiver of a clinical evaluation is usually intended only for non-critical products.