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MDR Annex IX Chapter I, 2.2 (c) - Device identification procedures during manufacture.

M

MiamiDM

Starting to get Involved
#1
#1
I hope you'll be able to help. The MDR fog has descended today and I'm struggling with a sub-section (see bold red text below) of Annex IX Chapter I, 2.2 (c). (page 147 of the MDR). Here's the context:

2.2 (c) the procedures and techniques for monitoring, verifying, validating and controlling the design of the devices and the corresponding documentation as well as the data and records arising from those procedures and techniques. Those procedures and techniques shall specifically cover:

— the device identification procedures drawn up and kept up to date from drawings, specifications or other relevant documents at every stage of manufacture,


Is this particular requirement saying that manufacturing records, e.g. a Device History Record should be in place and should allow for device identification throughout?

Please do correct me if I'm missing the point.


Thank-you
 
QMS for Medical Device Companies
Elsmar Forum Sponsor
Y

yodon

Staff member
Super Moderator
#2
#2
Not sure if this is right but the way I read it is that you should have procedures that describe how you identify a product throughout manufacturing. For example, if a step has an in-process test, do you know if the product has been tested or not and, if so, whether it passed or not. There should be some way of identifying whether tags or special bins or ...

I would think that there would be some way to also reflect the status in the manufacturing documentation (i.e., as you indicate, in a DHR).
 
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