"The CE mark endorses the specific device for sale in the EU not the manufacturer - if the manufacturers quality system/procedures are all that's verified, in all cases, then why not just endorse the manufacturer rather than type-test individual medical products when applicable?"
Richard, I stand to be corrected, but I have always understood that the CE mark superceded the GMP (Good Manufacturing Process) and is an endorsement that the manufacturer of a device meets all the requirements for the manufacture of that device ie that the correct materials and manufacturing processes are in place and that the instructions for use, labelling etc all meet the requirements laid down by the regulatory body.
As a result a manufacturer is then given a CE mark with a specific 4 digit code which said manufacturer then applies to ALL of its products.
The CE mark does not endorse the product as meeting the clinical specifications required.
