Fourth Amendment of the German Medical Devices Act: Presentation at the German Dentists’ Conference

The requirements of the Fourth Amendment of the German Medical Devices Act – is EDC a solution?

The Fourth Amendment of the German Medical Devices Act, which came into effect in March 2010, redefines how medical devices are clinically evaluated. As part of the clinical evaluation of a medical device, it must now be proven on the basis of clinical data that the performances of the product subject to proper use comply with the requirements of the applicable regulations and that the product has a justifiable benefit/risk ratio.

Particularly given the rising level of innovation in medical devices, there is a growing need for clinical trials to provide the necessary proof, as the usual practice of compiling available relevant scientific literature is only possible to a limited degree for such medical devices.

In the pharmaceutical sector, EDC systems have become established as a valuable instrument for carrying out clinical trials over the last few years. They are gradually replacing classic paper-based studies. EDC systems enable clinical investigators to directly enter the collected data into a central database. EDC solutions offer a host of advantages – most importantly improved data quality and a reduced workload for query management. Another key advantage is always having an overview of the progress of the study and the possibility to evaluate and interpret the collected data at any time.

EDC systems can simplify clinical trials for medical devices and provide a long-term solution to complying with the requirements of the Fourth Amendment of the German Medical Devices Act for a continuously updated clinical evaluation.

German Dentists’ Conference 2010
Frankfurt am Main, Congress Center Messe

Dr. Ulrike Jonas
The requirements of the Fourth Amendment of the German Medical Devices Act – is EDC a solution?

12 November 2010
Time: 9:45-10:30 am
Location: Forum, Konstant
Level/floor: C