Radiation Protection in Clinical Investigations: New Responsibilities and Procedures from July 2025
As of July 1, 2025, new regulations governing the notification and authorization of radiation use in the context of clinical investigations have come into effect in Germany. These changes primarily impact clinical studies involving medicinal products or medical devices that include the use of radioactive substances or ionizing radiation.
The legal basis for these changes is the German Radiation Protection Act (Strahlenschutzgesetz, StrlSchG), which defines the requirements for both notification (§32 StrlSchG) and authorization (§31 StrlSchG) procedures.
What exactly is changing?
- Submission of radiation-related applications will now be handled via the same portals used for study submissions:
- For clinical trials involving medicinal products: via CTIS (Clinical Trial Information System)
- For clinical investigations involving medical devices: via DMIDS (German Medical Device Information and Database System)
- Responsibilities for radiation use in clinical investigations are now clearly defined:
- Applications requiring authorization under Section 31 StrlSchG fall under the jurisdiction of the Federal Office for Radiation Protection (BfS) and the responsible Ethics Committee.
- Notifications under Section 32 StrlSchG are handled by the Ethics Committee and either BfArM or PEI (Paul-Ehrlich-Institut), depending on the product type.
- The distinction between notification and authorization procedures has been clarified:
- Notification procedure (§32 StrlSchG): Applies to standard diagnostic procedures accompanying treatment in ill participants—including minors—provided the effective dose does not exceed 6 mSv per person.
- Authorization procedure (§31 StrlSchG): Required when the research objective itself involves radiation use or when the dose limit is exceeded—for example, in studies involving healthy volunteers or high radiation exposure.
What does this mean for sponsors and medical device manufacturers?
The new regulations establish standardized submission pathways, reduce processing times, and clarify responsibilities.Further information on radiation use in clinical investigations is available from the Federal Office for Radiation Protection (BfS) and the Working Group of Medical Ethics Committees (AKEK).If you have questions regarding the implementation of these new provisions, we are happy to support you—from application strategy to submission via the CTIS or DMIDS portal.
