www.fdanews.com/articles/126260-device-trials-in-germany-now-require-approval
Device Trials in Germany Now Require Approval
April 15, 2010
Devicemakers
are required to get approval from the Federal Institute for Drugs and Medical Devices (BfArM) and an ethics committee before beginning clinical trials
in Germany. Previously, manufacturers had to notify BfArM of their trials and provide confirmation of the technical safety, trial protocol, insurance for
trial participants and approval by an ethics committee.
Clinical Trials Advisor
Clinical Trials Advisor