Clinical Studies
The Law and Clinical Trials In accordance with Section 20 sub-section 1 of the German Act on Medical Devices (“Medizinproduktegesetz”, … read more »
First Placing
What is the definition of First Placing? In the German version of Directives 90/385/EEC, 93/42/EEC and 98/79/EC, “Inverkehrbringen” is defined … read more »
Decision Makers
The German Institute for Medical Documentation and Information (DIMDI) The German Institute for Medical Documentation and Information (Deutsches Institut für Medizinische Dokumentation und … read more »
The Federal Institute for Drugs and Medical Devices (BfArM)
Medical Devices and BfArM Incident Reports The tasks of BfArM with regards to medical devices focus particularly on the evaluation … read more »