"Because CE Marking merely indicates that the product conforms to the minimum legal requirements, it does not ensure that the goods are quality products."
Are you sure you're referencing the relevant directives...
CE mark not only requires efficient quality system operation and explicit prior authorization concerning conformity and an assessment of the design documentation, but clinical data is required for all medical devices regardless of classification
Without positive safety and efficacy data from strict protocols designed to ensure high quality results it would not be in compliance with a CE marking.
