DoC (Declaration of Conformity) for Custom Made Medical Devices

kreid

Involved In Discussions
#1
Hello,
I am involved with the production of custom made class I devices and would like to find an efficient way of producing the Declaration of Conformity for each device.
Previously, producing non-custom devices we had one DoC per part number, this was simple to manage as the DoC only needed resigning if the was a change to the device (by part number for example).
However, with custom devices each one is different and so each requires an individual DoC each of which is signed by the authorised person.
Is there a way to avoid having to sign each DoC for every device.
We are trying to comply with the MDD.
Thanks
 
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RobertvanBoxtel

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#2
Re: DoC for custom made devices

Unfortunately, there is no way around it. Because if that process was to be standardized, it is not a custom made device anymore.

Please realize, in the new, proposal text for the Medical Device Regulation (Council Version), significant additional requirements are defined for custom made devices. I recommend you look into that text and prepare your QMS and technical documentation for these additional requirements, now in some situation also requiring Notified Body involvement.
 
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