The combination of all these standards forms the basics of all medical devices’ risk management. ISO 14971 provides the fundamental procedures to manage all risks while other standards that attend to only specific risks. The major difference between the ISO 14971 and other standards is their approach to risk management. There are other standards e.g IEC 62304, IEC 62366- 1, IEC 60601- 1, to mention but a few. These changes might seem insignificant, but most companies have had to revise their documents to accommodate the changes. Lastly, Production and Post Production Information became Production and Post Production Activities. The Risk Management Report is now Risk Management Review. For example, the Evaluation of Overall Residual Risk Acceptability was changed to the Evaluation of Overall Residual Risk. Likewise, some keywords changed in the latest version. Also, there changes in the arrangement of the steps between steps 3 and 10. Note the introduction of a new clause (Normative Reference) to the latest edition in the second step.

Production and Post Production activities.The current 2019 version unlike the 2007 version, has 10 clauses namely We’ll look at the changes adopted in the ISO 14971: 2019, but first we need to list the clauses. Production and Post Production Information.Evaluation of Overall Residual Risk Acceptability.General Requirement for Risk Management.The ISO 14971: 2007 had 9 clauses namely Most of the changes between the 20 ISO versions are in the clauses. Similarly, the introduction of ISO 14971 2019 version came with several changes that differ from the 2007 version. There are a lot of changes that came with the 201 version. Meanwhile, the rest of the world can use the 201 and the 201 standards for medical device risk management. In-vitro Diagnostic Medical Device Directive.Īs a result, any manufacturer that wants to sell their medical devices in Europe must comply with the EU 2012 harmonized standard.Active Implantable Medical Device Directive.The Harmonized European Version harmonized the three directives related to medical devices namely The European Union introduced a harmonized version that combined the two previous versions with new changes for European Device manufacturers. The product safety standard couldn’t address all the possible risks in medical devices, hence, the decision by the Standard Development Committee (SDC), to create ISO 14971, the first version of which was published in 2000. Then came the idea of ISO 14971 where manufacturers could apply the principles contained in ISO 14971 list to their medical devices to ensure safety. In general, it simply means that Risk Management helps us reduce risk.īefore the invention of ISO 14971, there were no standards for device manufacturers to use. Technically, we could say it involves Identifying, Assessing, and Prioritizing risks. It is imperative to understand the Application of Risk Management to Medical Devices. Application of Risk Management to Medical Devices Following ISO 14971:2019 Version

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