Besonderheiten von Medizinproduktstudien bei der Bewertung und Beratung durch Ethikkommissionen

The evaluation of the safety and performance of medical devices like implants, measuring devices or software may require clinical investigations sponsored by the manufacturer. Such clinical investigations need to be approved by the national competent authority and need the favourable opinion of the ethics committee. In the ethics committee’s view, clinical investigations of medical products are special in several respects: (1) Medical devices may be marketed without authorization; (2) the effect of a device may depend on the user; (3) study designs differ strongly because there are so many different devices; (4) authorities monitor medical devices with different intensity based on risk classes; (5) device regulations are less known to physicians and ethics committees, as device regulations are younger than those for drugs; (6) many small manufacturers are not prepared for clinical investigation; (7) medical devices tend to have short lifecycles and are developed incrementally, while investigations should be product specific; and (8) manufacturers use standards. Because of these peculiarities, ethics committee consultations need to consider some distinct points: the intended use and purpose of the medical device, general requirements, existing and achievable evidence, patient’s benefit, ambition of trial objectives, choice of comparator, changes to the clinical investigation plan, measures against bias, instruction of users and their learning curve, traceability of devices and of data, quality and risk management, custom-made devices, validated measuring instruments, standards and state of the art as well as funding. In short, ethics committees often have to refer to the rules and methods of evidence-based medicine.