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
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