ISO 14971 Implementation

Risk Management Principles for Medical Devices (ISO 14971)

The ISO 13485 standard stipulates risk management practices for all product realization processes in Section 7.1 to ensure that the “product safety” is assured before they are released to the market. According to the references given in ISO 13485, the implementation of the ISO 14971 standard by the manufacturer is the most appropriate solution to ensure the requirements for risk management.

In recent years, as a result of increased incidents within the European Union, the new MDR (EU 2017/745) and IVDR (EU 2017/746) have been issued by the EU Commission in order to improve the safety of the medical devices.

The EN ISO 14971: 2012 Risk Management standard should be used in product and whole product realization processes to comply with EU medical device regulations. The main text of this standard is basically in full conformity with ISO 14971: 2007.  But the Annexes ZA; ZB and ZC include the extra requirements and the so called “content deviations” which enable harmonization with the relevant legislation. According to this content deviations, in a basic risk management process outlined below, risk benefit analysis should be considered for each hazard and detailed in the risk report.

The annexes of ISO 14971 include useful information for the application of a risk management, which are informative. They constitute very useful examples especially for hazard identification and risk assessment.

ISO 14971 defines the risk management for medical devices with the following milestones;

  • Risk analysis
  • Risk assessment
  • Risk Control
  • Risk Benefit Analysis
  • Risk Management Reporting
  • PMS Review

The continual evaluation of these steps through the classic Plan-Do-Check-Act is the main criterion for a successful ISO 14971 application.

A hazard identification and risk assessment has to be carried out during the process. The process shall take into account the annexes of ISO 14971 and shall be applied consistently to all product realization processes. It shall be continuously monitored throughout the product lifecycle in line with clinical evaluation, information obtained from market surveillance and customer feedback.

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