ISO 14971 Implementation

Risk Management Principles for Medical Devices (ISO 14971:2019)

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.

ISO 14971: 2019 Risk Management standard, which has been issued towards the end of the 2019, should be used in product and whole product realization processes to comply with EU medical device regulations. Even though it has not been harmonized yet, it shall be used especially for the state of art for the MDR applications. Although the main text and approach of this standard is very similar to EN ISO 14971: 2012, there are differences and modifications, which will play a significant role for the compliance of the new regulation. The ISO 14971 has a different Annex structure compared to the previous version, where most of the Annexes of the old standard have been transferred to ISO/TR 24971. According to 2019 version of the standard, risk management process shall be planned according to basic flow outlined below, risk benefit analysis should be considered for each hazard and detailed in the risk report.

In order to comply with the new and revised regulations ISO 14971 shall be implemented for the application of a risk management process, which will improve hazard identification, risk assessment and risk benefit analyses.

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

  • Risk Analysis
  • Risk Evaluation
  • Risk Control (including Risk Benefit Analysis)
  • Evaluation of Overall Residual Risk
  • Risk Management Review
  • Production and Post-Production Activities

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/TR 24971 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.

Please feel free to contact us for detailed information on the changes and application areas of ISO 14971:2019.

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