A CE Marked Product that does not comply with the Standard



A particular company supplies a respiratory medical device (Class IIa). The primary Standard indicates that an integral connecting part should conform to the requirements of a secondary Standard. However, the company in question indicates; clearly in its IFU, that this connecting part does not meet the test requirements of this secondary Standard. As the overall device is CE marked is this illegal, as it does not conform fully to the Standard? If nothing else you would expect the company’s NB to raise this as a non-conformity. Thoughts?



Thanks for the reminder that standards are voluntary and as you point out it is the ER that is the key. But how could say within the ER that you demonstrate that you meet the requirements by complying with a Standard (in fact it is referenced on the device) – but indicating, that by the way we don’t agree it has to pass certain tests in this Standard. Do you just say that you believe these particular tests are not relevant for you to comply with the ER, and a NB just accepts this?



We have one device for which we claim compliance to 60601-1. However, it does not meet one particular clause - the limitation of voltage within a hand held part. But if we reduced the voltage the device would not be able to achieve it's clinical purpose. So that clause is marked as a "Fail" but with rationale.

That rationale is also included in the Operating Manual. This situation has been accepted by our NB.

Could the device that you are questioning be in a similar situation?


looking for answers
Could you ask the supplier for a copy of their ER checklist, or the rationale for their claim that, although it does not meet the standard it meets the ER criteria?


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Without knowing the specific standard and clauses it's impossible to give a thorough answer.

I would start by looking at the clause and establishing which ER's it is supposed to support the demonstration of compliance with; then consider yourself how you would justify compliance to the ER if you weren't using the standard.

I think ultimately you have to trust that this is a IIa product; the technical file should therefore have been reviewed by a notified body. Something like this shouldn't have been missed and will therefore have been thoroughly questioned by the notified body. If it is on the market it has passed their review and is compliant
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