[Authorization procedure of clinical trials with medical devices. First practical analysis of the BfArM]

The 4th amendment of the Medical Device Law introduced the authorization procedure for clinical trials with medical devices. The Federal Institute for Drugs and Medical Devices ("Bundesinstitut für Arzneimittel und Medizinprodukte", BfArM) has now drawn the first substantial interim balance on the basis of daily practice in order to describe results achieved by applications of clinical trials with medical devices. Overall, realization of the new authorization procedure of clinical trials is well underway. This empirical practical analysis of the first 405 applications points out further possibilities for improvements for future applicants. Furthermore, initial figures demonstrate the cooperative relationship with national and international applicants. Because the by far largest percentage of the premarket clinical trials with medical devices in the European Community are conducted in Germany (28%), the analysis also provides a comparison with other European countries in order to detect differences in specific areas as the result of the implementation of Directive 2007/47/EC.