Marc, this really belongs under medical devices, EU regulations, I think? If you agree, you might want to move it over there.
In the meantime...
Every CE marked medical device must be supported by a clinical evaluation, which means that all device regulatory professionals who have gotten a medical device CE marked have experience in using safety data for evidence for CE marking. The data may be from trials reported in the literature; or from trials the company sponsored. The depth and breadth of that experience undoubtedly varies.