Medical Device Clinical Investigation in Germany – Requirements of the Radiation Ordinances
This course provides a comprehensive overview of the regulatory requirements in Germany for the use of diagnostic or therapeutic ionizing radiation during clinical investigations.
The course covers :
- How the Medical Devices Act (MPG) links to the Ordinances for protection from radiation (StrlSchV and RöV)
- The scope of the radiation protection ordinances related to clinical trials
- A clarification of the applicable definitions
- The conditions and context of use - medical or research
- The pathways to obtain an authorization
- The use of radiation as accompanying diagnostics (Begleitdiagnostik) with its simplified pathway for obtaining an authorization
- A summary repeating the key points.
Upon completion of this course, trainees will be able to correctly and successfully:
- Compile clinical investigation notification to Germany for studies involving, e.g., x-ray diagnostics or scintigraphy
- Apply for an authorization for the use of radiation based diagnostics or therapy within the framework of clinical investigations for the “Bundesamt für Strahlenschutz” (BFS)
- Include the radiation approval process in the timelines to start a clinical investigation in Germany when radiation is involved.
Investigators in Germany, study coordinators, hospital staff responsible for radiation protection and involved in clinical investigations, clinical research project managers, clinical directors and regulatory managers, clinical research associates involved in submissions and conduct of clinical investigations in Germany.
Conducting Medical Device Clinical Investigations in Germany (ID N157).