As of 1st of July 2025 regulations associated with the use of radioactive substances or ionizing radiation has changed to ease the process for applications in order to carry clinical trials for drugs & medical devices.
That has been implemented through providing a single-gate approach where you only require to submit a single application through the same system rather than having to submit two different application one for the clinical trial & one for federal office of radiation protection, by doing so it has made the application process much more seamless, faster & ensure laws harmonization for radiation, drugs & medical devices.
So, what is the difference between notification & approval?
Your project only needs notification (simpler process) if:
- You're testing the effectiveness or safety of a treatment (not the radiation itself).
- The radiation technique used is already standard in clinical practice.
- Only patients with the condition being studied are included (not healthy volunteers).
- The radiation dose per person is under 6 millisieverts (even for minors).
Full approval is needed in cases of:
- If you're studying healthy individuals
- If you're including minors and the radiation dose is above 6 millisieverts
- If your study is not considered a clinical trial under drug or device regulations
In those cases, you must get full approval from the (Bundesamt für Strahlenschutz, BfS), based on radiation protection law.
In conclusion, most standard clinical trials using radiation on patients can now go through one application system with a simpler notification process, except special cases like mentioned above would require full approval.
