CE Mark Requirements on Kits (off the shelf product requirements met)

Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#1
Since I had this encounter I thought I would share advice from the US Dept of Commerce on this. (Edited for privacy concerns)

"Finally, you say you don’t have any control over the smartphone. If that smartphone is part of a medical kit that has your company name on it, then you are responsible for the smartphone. You need to make sure the smartphone company met CE mark requirements (probably for the Radio Equipment Directive). You should get some paperwork from them indicating they met the requirements of the Radio Equipment Directive, what standards they used and preferably what lab they used. This way, if something goes wrong with the smartphone that causes an injury, you can at least claim that you did due diligence and according to the smartphone company, they claimed they met CE mark requirements and used such and such a standard and got the product tested from such and such lab. If your medical device is electrical, then it will need to meet the RoHS (Restriction of Hazardous Substances) Directive, as will the smartphone. The RoHS Directive is another directive the smartphone people have to meet.

Assuming all those conditions above are met (ie your product has met CE mark requirements and the smartphone has met CE mark requirements), then you just CE mark the kit. A CE mark on the outside of the kit means that everything inside the kit has met CE mark requirements. You can just leave the CE mark on the smartphone as it is but please keep in mind that your company is responsible for all the contents of that kit so make sure the smartphone has met all CE mark requirements (ie, Radio Equipment Directive and RoHS Directive.)

Thanks,


Office of Western and Northern Europe
US Department of Commerce"
Tel 202-xxx-xxxx
 
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Cali_Kitson

Starting to get Involved
#2
Hey @Ed Panek !

Interesting post - got me thinking about a challenge we are currently having.

We supply an off the shelf android tablet in our medical device system, the tablet itself is assembled into a carry case but is not modified in any other way, we have all the information to ensure CE mark requirements have been met, so we thought everything was all good!

However, we are being told by customs we need to retest as per UN38.3... This seems completely unnecessary!

Does anyone have any thoughts on this?
 
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