I agree with previous posts in regards to NB-MED Guidance Documents being one of the most useful documents. Since it is written by the notified bodies, it is very useful that they do have the authority to assess and verify the clinical evaluations provided by the manufacturers and decide whether to pass or fail any device. Also, they are contracted by the EU and are the central piece of its regulatory structure that performs the necessary risk analysis and identifies undesirable side effects. In addition, the Competent Authorities accept their judgement on the necessary medical devices.