Medical Device Clinical Investigation in Germany – Requirements of the Radiation Ordinances
Course Description:
This course provides a comprehensive overview of the German regulatory requirements for the use of diagnostic or therapeutic ionizing radiation during clinical investigations.
It covers the following topics:
- How the Medical Devices Act (MPG) is linked to the StrlSchV and RöV radiation protection ordinances
- Scope of the radiation protection ordinances related to clinical trials
- Clarification of applicable definitions
- Conditions and context of use (medical or research)
- Pathways to obtain authorization
- Use of radiation as an accompanying diagnostic (Begleitdiagnostik)
- Summary of key points
Watch the Course Trailer:
Learning Objectives:
Upon successfully completing this course, learners will be able to:
- Compile clinical investigation notifications to Germany for studies involving x-ray diagnostics, scintigraphy, and more
- Apply for an authorization for the use of radiation-based diagnostics or therapy within the framework of Bundesamt für Strahlenschutz (BFS) clinical investigations
- Incorporate the radiation approval process to clinical investigation timelines
Who Should Enroll:
Investigators in Germany, study coordinators, hospital staff responsible for radiation protection and involved in clinical investigations, regulatory managers, and clinical research project managers and associates involved in submissions and conduct of clinical investigations in Germany are all welcome to enroll in this course.
Prerequisite Knowledge/Requirements:
The following course is required:
- Conducting Medical Device Clinical Investigations in Germany (ID N157)