Software in Medical Devices, by MD101 Consulting

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IEC 62366-1 becomes recognized by the FDA

Long time no see. For those of you guys who have been following this blog for a long time.
Today I have time to write a short article on the new version of IEC 62366 standard: IEC 62366-1:2105 Application of usability engineering to medical devices.

It was first published by the IEC at the beginning of 2015. Then the FDA was quick to add it to its list of recognized standards. It was published in the Federal Register in August 2015 and the old version was marked withdrawn.
It looks like the FDA wasn’t happy with the previous version to be so prompt to add the new one and withdraw the old one (pure speculation of mine).

Difference between US and EU

We are now in a situation where the FDA recognizes the IEC 62366-1:2015 while the European Commission still references the IEC 62366:2007 in the list of harmonized standards. Discrepancies between standards versions can be difficult to handle.
For those of you who know the changes in versions of IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance, you know the hassle it can be. Fortunately, the case is more simple with IEC 62366.

If your company designs products to be sold on the US and European markets, you’d better choose IEC 62366-1 than the old version. Why? Because it’s probably easier to bring evidence that you’re compliant with European regulations with the new standard (namely essential requirements about usability) than to bring evidence that you’re compliant with US regulations with the old standard that was withdrawn.
Add to this that IEC 62366-1 should be referenced in the list of harmonized standards sooner or later. Thus there’s really no use to continue applying IEC 62366:2007 for new designs.

Consequence on IEC 60601-1-6

Coming back to IEC 60601-1, the IEC 60601-1-6 Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability references IEC 62366. It basically takes IEC 62366 as is and adds some changes on the scope of products and some requirements on instructions for use.
Even if IEC 60601-1-6 references the old version of IEC 62366, it is easy to apply the changes required by IEC 60601-1-6 to IEC 62366-1:2015 hence the wording of IEC 62366 hasn't changed. Thus, there's once again no use to continue applying the old version of IEC 62366.

IEC 62366:2007 is dead

As a consequence you have now to rely on the new usability engineering process defined in the requirements of IEC 62366-1. It is not easy to implement as it brings new concepts: formative evaluation and summative evaluation.
We already talked about that in a previous article. Just to say that if you’ve been waiting for the last moment to change your design procedures to be in line with IEC 62366-1, uh, now, it’s time.

Edit: fixed dates of IEC 62366 thanks to remarks of Denys Durand Viel of DM Experts.


1. On Friday, 17 June 2016, 10:25 by Luis G

You have posted a template for the Usability Specification Document, but since the norm has changed, does the document need to be updated or it can be used the same template?

You blog has been a lot of help

2. On Thursday, 23 June 2016, 21:06 by Mitch

Thanks Luis for your feedback.

No, the actual template doesn't match the new requirements of IEC 62366-1 on formative and summative evaluation. I add  to my todo list the action to update the template.

3. On Tuesday, 29 August 2017, 13:48 by joko

Is the update of the template still on the todo list? I am looking forward to the updated version.

4. On Wednesday, 30 August 2017, 18:05 by Mitch

I wish I had time to do so.

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