Risk analysis is a series of steps that use available data to identify safety-related features, identify hazards, and estimate each hazard of medical devices in both their normal and defective states.

For MDR, IVDR, FDA, or any other regulation, the manufacturer must establish the device’s safety. As a result, risk analysis based on ISO 14971 is required and becomes a requirement. This standard’s requirements apply to the whole life cycle of a medical device.

Risk Analysis shall be carried out in three stages.

  • Intended use and identification of characteristics related to the safety of the medical device- in this step, identify the quantitative and qualitative attributes of a medical device and its possible misuses.

  • Identification of Hazard- in this stage, identify all possible hazards of a medical device in its regular use and faulty condition.

  • Estimation of Risk for each Hazardous Situation- the Risk is estimated for each hazardous situation in this stage. Also, one can use any system to estimate the probability and severity of harm; this could be quantitatively or qualitatively.

The manufacturer must show conformance with the general safety and performance requirements, as well as other requirements such as quality and medical device risk management, according to MDR and IVDR Essential Requirements. EN ISO 14971:2020 is currently harmonised with MDR and IVDR.



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Assume that the residual risks are unacceptable even after medical device risk management procedures have been adopted. In that instance, we perform a risk-benefit analysis to show that the device’s benefit surpasses the hazard. To do so, all remaining risks and advantages associated with the device’s intended purpose are analyzed subjectively and statistically to arrive at a risk-benefit ratio assessment. The benefit-risk analysis analyses if the benefit is greater than the hazard.
The risk-benefit analysis must be conducted to demonstrate that the device’s benefit outweighs the risk associated with it to show the device’s safety while performing its intended function and overall risk acceptance.
The worldwide standard for doing risk-benefit analyses for medical devices is ISO 14971. Suppose the remaining medical device hazards are unacceptable even after implementing risk management measures. In that case, we do a risk-benefit analysis to demonstrate that the device’s benefit outweighs the risk. To do so, all remaining hazards and advantages associated with the device’s intended purpose are examined subjectively and statistically to arrive at a risk-benefit ratio value estimate. The benefit-risk analysis analyses if the benefit is greater than the risk. The benefit-risk balance must be based on appropriate clinical evidence and be reviewed and reassessed regularly.


Though risk analysis is a process that may begin at the design stage of a device and continue throughout its life cycle, a third-party consulting firm can assist you in a variety of ways.

  • Creates a medical device risk management procedure in accordance with the most recent harmonised standard.
  • Examines existing papers linked to the customer’s risk management file and can identify and fill up gaps with needed information, particularly for hazards, risks, and risk mitigation.
  • Determination of new risks
  • Records risk management activities such as planning, reporting, evaluations, the efficacy of risk control measures, and risk management file post-market activities.
  • For the remaining risk, a risk-benefit analysis uses manufacturer information and literature searches to demonstrate that the medical benefit outweighs the residual risk.
  • Writes the reports and conclusions.
  • As consultants with up-to-current expertise, we can assist you with keeping your risk management file up to date, as well as obtaining certification in a shorter amount of time.


The Risk Management Report must include an evaluation of the whole risk management process, which must include the following:

  • a risk management strategy, whether it is well executed
  • if the overall residual risk is acceptable
  • if proper control measures are adopted;
  • whether suitable approaches for obtaining relevant production and post-production data are used
  • conclusions

The outcomes of these actions must be highlighted in the risk management report. According to MDR/IVDR, a medical device’s technical file must include a risk management report that demonstrates compliance with general safety and performance criteria, as well as other quality and risk management requirements.


You must include a concise explanation of the risk evaluation and control methods you have implemented and the activities in the hazard traceability matrix. Include the general acceptability of risks, residual hazards after implementing risk management measures, and efficacy control methods. Describe how the device’s medicinal value outweighs the residual risks.


We developed medical device ISO 14971 Risk Analysis Procedures and Templates in compliance with MDR and IVDR. CE Certification is only achievable if adequate risk management files are connected to the technical documentation. Those who do not have enough time or expertise can utilise our edit and use word files. Buy now!

  • Complete set of documents available for online purchase.

  • Procedures and templates drafted by regulatory experts with prior experience

  • Six month free updates


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