IEC 62366 is currently up for Revision:
A decision on whether the standard IEC 62366-1:2015 ‘Medical devices — Part 1: Application of usability engineering to medical devices’ should be revised is currently being voted on by both IEC and ISO. The result will be announced in early September 2020.
Three Reasons why I believe IEC 62366 should be Revised:
For my part, I feel that we do need to revise the standard although it was last revised in 2015. I outline below three reasons why I feel it IEC 62366 should be revised. I would love to hear your opinion whether you agree with me or not.
1. IEC 62366 was based on ISO 14971:2007.
IEC 62366 is intended to implement specific parts of the risk management process defined by ISO 14971 with respect to usability risk; however, IEC 62366-1:2015 was written based on the requirements of ISO 14971:2007 which has since been withdrawn and replaced by ISO 14971:2019 therefore, I recommend that IEC 62366 should be revised to better align with the terminology used in ISO 14971:2019. Whilst it is true the changes incorporated in ISO 14971:2019 did not fundamentally alter the requirements for risk management the changes did; however, involve better alignment of its requirement with that of regional and national medical device regulations (in particular EU regulations) therefore revising IEC 62366 would enhance the harmonisation of this standard (IEC 62366) with the EU MDR and IVDR.
2. IEC 62366 was originally written with active Medical Devices in Mind.
IEC 62366 was originally written with active medical devices in mind; however, it applies equally to the usability of non-active devices; therefore, I recommend that it should be revised to add terminology and examples related to non-active medical devices.
3. Increased Use of Autonomous Elements in Medical Devices.
With advances in the incorporation of autonomous elements in medical devices, the usability-related risks associated with (partially) autonomous medical devices will become more common; therefore, I recommend that IEC 62366 should be revised to add terminology and examples related to autonomous or partially autonomous medical devices.
What is your view?
We deliver training courses in IEC 62366 Application of Usability Engineering to Medical Devices’ and also IEC 62304 Medical Device Software – Software Lifecycle Processes through our training partners, SQT Training. Find out more about these courses.
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About the Author - John Lafferty
John Lafferty is the owner of the Northridge Quality & Validation which provides consultancy to the Medical Device industry.
John's specialities include Software Validation, MDSAP, ISO 13485, ISO 14971 and MDR. John is the holder of a Degree in Manufacturing Technology, Certificate in Training & Continuing Education, Certificate in Quality Management.
John Lafferty has over 25 years’ experience in the medical device and pharmaceutical industry. He was a Senior Manager of a multinational Medical Devices plant where he managed the Quality, Regulatory, Environmental and Health & Safety Management Systems. He has successfully completed numerous consultancy projects with medical device manufacturers in Ireland and throughout Europe.
SQT Training Tutor
John is also a Life Sciences Tutor with SQT Training