Conducting Medical Device Clinical Investigations in Germany
This course outlines how to conduct clinical investigations for medical devices in Germany. It provides a step-by-step review of the DIMDI notification process, as well as valuable tips for navigating the ethics committee notification process, including instructions for documents that must be submitted and clinical trial insurance requirements.
This course also reviews the regulatory requirements for reporting during clinical investigations, including safety reporting and reports needed for closures.
The content of this course is based on the requirements defined in the German Medical Device Act (MPG), additional regulatory requirements outlined in the MPKPV, and applicable sections of other ordinances, such as those covering radiation protection.
Upon successfully completing this course, learners will be able to:
- Compile submissions to BfArM and German Ethics Committees in compliance with German requirements
- Determine when more simplified submissions can be used
- Comply with reporting requirements for clinical investigations
- Effectively close down a clinical investigation in Germany in accordance with local and national regulations
Clinical research associates, investigators, study coordinators, clinical project managers, and regulatory managers involved in clinical investigation notifications to BfArM through the DIMDI and German Ethics Committees are all welcome to enroll in this course.
The knowledge covered in the following courses are pre-requisite:
- An in-depth knowledge of good clinical practice as outlined in the program for effective monitoring for medical device clinical investigations
- A basic knowledge of medical device clinical evaluation as outlined in the program – clinical evaluation for market approval (ID 116)
- Importance of Clinical Investigator’s Brochure (IB) (ID 117)