Medical Device with Electronics Functions



I have a question about the technology of a medical device.

For a device used by the patient, if the device works electrically, is it necessary to plan a manual use to mitigate the dysfunction of the electronics?

Thanks you for your comments.


Super Moderator
Without knowing more, it probably falls into the "it depends" category.

If the electronic dys / mal -function could result in patient harm then just documenting it is probably insufficient (for mitigation - and bear in mind the harmonized version of 14971 doesn't allow risk reduction for just documented controls).

If it doesn't result in any patient harm but the user has to do something to get the system operational again, then yes, having something in the manual is probably warranted.

If your question of dysfunction is trying to address any random failure and the user detects it (no display, obviously erroneous operations, etc.) then maybe just a generic statement to contact customer service (or whatever is appropriate).

I'd say that documenting something falls pretty low on the effectiveness scale, for whatever reason it would be documented. But there are obvious cases where it at least should be done.


Quite Involved in Discussions
I am a wee sceptical if there is an identical mechanical back up system next to electronics. It would blow up the engineering cost further it is highly likely not feasible at all due to size constraints.
I could foresee solely emergency measures for these cases.


Thank you for your feedback. :)

I have part of the answer in the Directive 93/42/eec (?12.1).
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