Risk Assessment the MDR
When it comes to the performance and safety of medical devices, the requirements vary depending on the nature of the device in question and intended purpose of use.
Risk Assessment Process
Stipulations go far beyond the requirements regarding design and manufacturing. Manufacturers are also required to establish, implement, document and maintain a risk management system. It is obligatory that any risks that 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. Furthermore, it is necessary to reduce risks as far as possible without adversely affecting the benefit-risk ratio.
Risk management standards
The risk assessment procedure is defined by ISO 14971, whereby risk management is a continuous iterative process throughout the entire lifecycle of a device, requiring regular systematic updating. The requirements defined in ISO 14971 are quite complex. Formal questions often arise during a risk assessment when performed by medical and technical experts.