Medical technology working group

Considering the unique issues affecting clinical trials on medical devices

The main focus of the medical technology working group is clinical trials and studies on medical devices in accordance with the German Medical Devices Act (MPG). The goal of the joint activities is to ensure the conformity and quality of clinical trials on medical devices in accordance with the German Medical Devices Act.

Checklists and guidelines are to be developed which take account of the unique issues facing clinical trials on medical devices:

No double blinding option
Invasiveness of the intervention
Consideration of benefit vs. harm
Rapid enhancement of the state of the art
Dependency on special user know-how, operational environment, etc.

Sub-issues are:

Support for usability tests in the context of evaluation trials
Health Technology Assessment (HTA) and InnoHTA
Trials in the context of telemedicine
Special trial requirements for the subject of "Plug&Play"
Integration of method approaches from the fields of clinical trial, usability and effectiveness trials
Trial requirements relating to complex product and treatment systems with medical devices
Consideration/development of registers within the trial context

In April 2008, the medical technology working group was officially approved by the Board of Directors following its constituent meeting. The group is now planning a study of the topics in preparation for projects on the key activities mentioned.

(Letzte Aktualisierung: 04.07.2017)

Spokesperson

N.N.

Vice spokesperson

Thomas Norgall

Fraunhofer Institute for Integrated Circuits IIS

Phone: +49 9 131 776 73 05 | E-Mail

Contact at the TMF Office

Sebastian C. Semler

Phone: +4930 22 00 24 70 | E-Mail

Medical technology working group 2011

February 9, 2011 in Berlin

L.t.r.: Stefan Müller-Mielitz (Kompetenznetz Angeborene Herzfehler), Annika Ranke (UniTransferKlinik Lübeck), Dr. Uwe Behrens (KKS Charité), Anja Malenke (FUSION), Dr. Rainer Röhrig (GOLDnet), Dr. Hildegard Niemann (Begleitprojekt "Innovative Hilfen" am ZiG), Stephan Pöhlsen, Marcel W. Engel (SKELNET), Dr. Reinhard Vonthein (Kompetenznetz Multiple Sklerose), Dr. Raimund Mildner (FUSION), Dr. Johannes Drepper (TMF), Thomas Norgall (Fraunhofer IIS), Gunnar Nußbeck (UMG), Dr. Horst Frankenberger (FUSION), Johannes Dehm (Deutsche Gesellschaft für Biomedizinische Technik), Dr. Steffen Luntz (KKS Heidelberg), Mathias Freudigmann (TMF), Sebastian C. Semler (TMF), Dr. Silke Müller (DKFZ).

Medical technology working group 2010
		Meeting in Berlin 1st row: (l.t.r.): S. C. Semler (TMF), T. Norgall (Fraunhofer AAL), Dr. S. Müller (DKFZ), Dr. C. Geßner (TMF), Dr. M. Seibert-Grafe (IZKS Mainz), M. Freudigmann (TMF), Dr. A. Zimolong (Synagon GmbH), Prof. Dr. H. Frankenberger (FUSION), Prof. Dr. O. Rienhoff (Universitätsmedizin Göttingen); 2nd row: G. Nußbeck (Universitätsmedizin Göttingen), A. Ranke (FUSION), I. Bruns (KKS-Netzwerk), A. Malenke (FUSION), Dr. R. Mildner (FUSION); 3. Reihe: S. Müller-Mielitz (Kompetenznetz AHF), Dr. D. Lühmann (FUSION), Dr. R. Vonthein (Universität Lübeck), Dr. P. Buch (Projektträger im DLR).
Medical technology working group 2008
		Constitutional meeting on April 24, 2008 in Berlin L.t.r.: M. Freudigmann (TMF), P. Buch (PT DLR), P. Neuhaus (KSL), A. Ziegler (Univ. Lübeck), R. Mildner (FUSION), A. Malenke (FUSION), S. Müller (KN AHF), D. Lühmann (Univ. Lübeck), W. Lauer (Orthomit), H. Frankenberger (AG Medizintechnik in Schleswig-Holstein e.V.), K. Becker (Orthomit), T. Norgall (Fraunhofer IIS), S.C. Semler (TMF), K. Lohmann (PT DLR), M. Kleemann (Klinik für Chirurgie, Universitätsklinikum Schleswig-Holstein), A. Pollex-Krüger (TMF), J. Dehm (DGBMT).