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Risk is a function of hazard severity and the probability that a hazard will occur. The assessment of safety involves balancing the risks that cannot be eliminated from the product against the benefit and utility of the product.
Risk management is required by the three European Union Medical Device Directives (Active Implantable, Medical Devices and In Vitro Diagnostics) and by the FDA’s Quality System Regulations. Risk Analysis is required by ISO 13485: 2003.
In the EU, a Risk Management File according to the international standard ISO 14971 is required for all medical devices and it is an obligatory part of the CE Master File.
The standard exists to ensure that (residual) risks associated with a device have been reduced as far as practicable and that the cumulative effect of those risks cannot present an unacceptable risk to patients, users, other parties or the environment. The standard establishes a method for achieving this which is acceptable to auditors and regulators.
The method prescribed by ISO 14971 requires:
- Establishing risk indices for individual hazards (i.e. potential sources of harm). This includes the identification of every possible hazard associated with the device;
- The estimation of the likelihood of each hazard to occur;
- The potential severity of the harm provoked by each hazard;
- Graphical and mathematical techniques to calculate the risks associated to the device;
- Description of risk control measures;
- After all risk control measures have been implemented and verified, decision if the overall residual risk posed by the medical device is acceptable;
- Ascertaining if the medical benefits of a medical device, based on the review of the available data and literature, outweighs the overall residual risk if this was judged unacceptable according to the criteria established in the Risk Management Plan.
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