Establishing benefit/risk ratio for medical devices

The MDR and IVDR General safety and performance requirements demands the manufacturers to design and manufacture devices in such way, that ‘any risks which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety, taking into account the generally acknowledged state of the art. In other words, the regulations require the devices to have positive benefit/risk ratio.

It is very likely, that you will not succeed to find any universal and comprehensive guideline on how to evaluate the benefit/risk ratio. At the same time, it is known that plenty sources of data have to be used to establish the ratio. The following sources must be considered, at least:

• Design and development;
• Risk management;
• Data on similar/equivalence devices;
• State of the art;
• Clinical/performance evaluation;
• Post-marketing data.

Determination of benefit/risk ratio for medical device is quite a creative task since the manufacturer must choose and to justify the methodology for such determination. Beyond doubt, each individual medical device may require a special approach.

STARoDuB medical device team has sufficient experience to provide input to the benefit/risk determination of your medical device, as well as to provide you any kind of support with respect to medical devices risk management. Take a look on the medical device services on our website.