CE Marking of Customized Ruggedised Computer Systems Solutions

U

Unsettled

#1
Hi,

We sell ruggedised computer systems which are comprised of some electronics designed by us and also off-the-shelf parts (RAM, processor, graphics board).

We are going through the CE Marking process and will self declare. EMC tests have been at an authorised test lab of the typical system.

Our challenge is understanding how to deal with customised solutions, where some parts inside the computer may be different, and even some external connectors may be different.

Taking each customised solution to a test lab would add so much cost as to make the unit an unattractive purchase.

What strategy are people using in this case. I am sure we are not the only people wanting to sell customised solutions that are CE Marked.

My first post here but have been lurking for a few years! So much great information and helpful people.

:applause:
 
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pkost

Trusted Information Resource
#2
Re: CE Marking of customised solutions

Is your device integrated into the computer system? Is it connected by PCI? USB?
A computer is not typically considered a medical device as it is not intended by the manufacturer to be used as such.

I would probably treat the interface between your product and the computer as the end point of the MD regs; thereby avoiding any issues with the computer being customised
 
U

Unsettled

#3
Re: CE Marking of customised solutions

Thanks for the reply pkost.

The computer IS our device, and not a medical device. This is a ruggedised computer that is typically installed into a larger system.

We design the form factor, the mechanics and put it all together ourselves. There are some IO boards we design ourselves which are included, and the power supply inside the box is our own design. Then there are also parts from other vendors.

Our customer will often ask for specific hardware to be included as well, and this is where we are not sure how to deal with the CE Marking. The change could be connectors on the outside of the box, or different PCBs inside the box or both.

The different possible combinations are close to limitless..
 

pkost

Trusted Information Resource
#4
Re: CE Marking of customised solutions

Ah, sorry, ignore my previous comment, I had incorrectly assumed this was in the medical device section of this site!

I will read more carefully in future!

Unfortunately I know nothing about this so cannot help
 

CharlieUK

Quite Involved in Discussions
#5
The EMC Directive requires you to perform an "assessment".
this typically involves some testing - preferably of configurations that you can justify as being representative, or even better, "worst case". Under the original EMC directive you would create a Technical File and have it reviewed by a Competent Body - there's no mandatory requirements under the current EMC directive to do anything other than a manufacturer assessment, but there is the option of using an EMC Directive Notified Body to review you technical argument and test results should you wish.

Assessment against LVD requires something similar - assuming that you have a fully certified power supply, the main issue is how much power you draw from it and how hot everything gets under worst case load conditions

You also need to have a process for ensuring that all your custom combinations are compliant with the RoHS directive.

Things get more complicated if you integrate WiFi or Bluetooth as you will then have created a Radio Product and fall under the Radio Equipment Directive

Charlie
 
U

Unsettled

#6
Thank you CharlieUK

This is the approach we have taken - EMC testing a representative configuration.
 
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