Medical Device Risk Analysis ISO 14971

Medical Device Risk Management File (RMF)

EN ISO 14971:2012 is the latest international standard for the Medical Device Risk Management Process for the Medical Devices( As per Harmonized Standards). Risk Management Process contain 3 important parts:

  • Risk Analysis
  • Risk Evaluation
  • Risk Control

The Risk Analysis is the starting phase of the risk management process for a medical device. A medical device risk management plan is determined and implemented. The three important stages of Risk Analysis Process are below

  • Identification of the intended use and characteristics related to the safety of the medical device.
  • Identification of known or foreseeable hazards
  • Estimation of the risk for each hazardous situation

Risk management Procedure and Report

Thus risk analysis is the systematic use of the available information to estimate the risk in the identified hazards. The risk analysis activities and the results are recorded in a risk management file. Some of the Risk Analysis techniques explained in the standard are:

  • Preliminary Hazard Analysis (PHA)
  • Fault Tree Analysis (FTA)
  • Failure Mode and Effects Analysis (FMEA)
  • Failure Mode, Effects and Criticality Analysis (FMECA)
  • Hazard and Operability Study (HAZOP)
  • Hazard Analysis and Critical Control Point (HACCP)

Depending on the intended use, characteristics, present stage of development of the medical device one or more of the above techniques can be used for the risk analysis.

Medical Device Risk Management plan

Risk management activities must be planned for every project before initialization of risk analysis activities.

  • The planning of risk activities shall be coherent with the risk class of the device and Intended use
  • Putting together your risk management team.
  • Important, list the deliverables and reviews of each phase of the project
  • Suggetions for overall improvement as per Notified Body requirments.

Role of Consultants in Risk Management File for MDR CE Marking

  • Review the hazards and control mesures taken
  • Development of annexures as per standard
  • Guidance and suggetions for closing the identified GAPS.
  • suggetions for overall improvement as per Notified Body requirments.

Please write to for more information.

  • Risk Management Framework & Planning covering process involved in the development of the device, persons involvement with responsibility with a suitable plan.
  • Risk Analysis with regard to defining the intended use of the product.
  • Risk Evaluation by Identifying severity and occurrence (probability) of risks
  • Risk Control where the actual implementation of risk mitigation
  • Development of Reports with Conclusion.

  • Rationale for requirements (Annex A)
  • Overview of risk management process (Annex B)
  • Questions that can be used to identify device characteristics that could impact safety(Annex C)
  • Risk concepts applied to devices(Annex D)
  • Examples of hazards, foreseeable sequences of events, and hazardous situations(Annex E)
  • Risk Management Plan(Annex F)
  • Information on risk management techniques(Annex G)
  • Guidance on risk management for in-vitro diagnostic medical devices(Annex H)
  • Guidance on risk analysis process for biological hazards(Annex I)
  • Information for safety and information about residual risk(Annex J).

  • Medical Device Medical Device risk management plan contains the following personells
  • Medical Device Risk Management Team)
  • Medical Device Risk Mitigation Team
  • Medical Device Risk Analysis reporting and Conclusion

EN ISO 13485:2016 and Risk Analysis.Click here

More details about risk criteria.Click here


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