Failure to test Class I medical device to IEC 60601-1-11


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Hi All,

If the manufacturer of a class I medical device which is electrically powered and for use in private homes fails to test their product to the Home Healthcare standard 60601-1-11 before self declaring and releasing for sale, what would be the consequences. Would anybody notice, and if they did what would the consequences be should the omission be reported to the competent authorities.

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In the short term, I doubt that anyone would anyone notice. Competent Authorities can request the technical files for Class I products, in which case it would become evident that not all testing had been performed. This CA request does happen but is not frequent. The consequence - probably a withdrawal from the market until the testing was complete. I am not aware of any fines (or worse) being imposed under the MDD.

Peter Selvey

Staff member
I'd be a little more cautious, in the sense that if anything goes wrong legal negligence could be on the table which can add an extra zero to liability or result in criminal action.

I know that some things in IEC 60601-1-11 are over the top, which is the result of the standard covering everything from simple low cost battery operated stuff though to complex home dialysis or oxygen therapy.

For a simple, low risk Class I device, I'd still recommend preparing a checklist/report but feel free to modify the standard where it makes sense, using comparisons for everyday home use devices to show that no significant risk exists, which can be formally justified in risk management. That way, it's also OK even if a CA gets involved.
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