1. Stricter clinical functional requirements
According to the new EU MDR, proof of the clinical effectiveness of a medical device and patient protection is generally provided by means of a specialist medical evaluation of medical devices. 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. A waiver of a clinical evaluation is usually intended only for non-critical products.
At the same time, the manufacturer must submit a clinical development plan, including a post-marketing clinical follow-up plan.
If comparison products are used for clinical evaluation, then the comparison products must be technically, biologically and clinically equivalent. As with the old MEDDEV 2.7 / 1, there should be no clinically relevant differences. Manufacturers must demonstrate equivalence by providing the data of the reference product. Class III and implantable devices can only rely on comparability data if the manufacturer has the (foreign) devices that are used for the comparison, for example, and is thus able to generate the necessary data. As a rule, however, he needs a contractually regulated access to all data and test results of the (third- party) product.
Clinical trials of medical devices must be planned and performed in accordance with EN ISO 14155 "Clinical Testing of Medical Devices to Humane Clinical Practice" and other regulations.