company predictions, page-26

Hi Col - no governmnet authorities are involved in the granting of a CE mark. AS a general rule, a manufacturer or distributor is required to self-certify that they comply with applicable EU directives. In teh case of certain products which could cause harm such as medical devices, there is still no government/regulatory approval involved, however, the EU directives require an independent third party (like an auditor) to confirm compliance.
If you look up CE marking online you will see a lot of organisations touting their wares as CE certifiers (or as they are called "Notified Bodies").

In TIS's case, I understand that they are using BSI, whose website professes that "BSI is a respected, world-class Notified Body dedicated to providing rigorous regulatory and quality management reviews and product certifications for medical device manufacturers – around the world".

YOu can even get a quote online for a CE mark from BSI if you like.

Point is that we arent dealing with regulatory biodies here, we are dealing with private companies awho are certifiying for a fee. No doubt they have professional obligations similar to company auditors, but we are not dealing with faceless bureacrats, but with a company that we are paying for the service. This would also strongly suggest that there would be regular dialogue going on between TIS and BSI about what is going on.