Notification and Approval Procedures under Radiation Protection Law
New radiation protection regulations effective 1 July 2025
The use of radioactive substances or ionising radiation for medical research purposes (hereinafter: radiation applications) may be subject to approval in accordance with Section 31 of the Radiation Protection Act (Strahlenschutzgesetz, StrlSchG) or the submission of a notification in accordance with Section 32 of the StrlSchG.
If such radiation applications are to take place in the context of a clinical trial of a medicinal product or a medical device, then the radiation approval application or notification process will be integrated as of 1 July 2025 into the application or notification process for the clinical trial itself via the following platforms:
- via the European Clinical Trials Information System (CTIS) for medicinal product clinical trials
- or via the German Medical Device Information and Database System (DMIDS) for medical device clinical trials.
The BfArM provides an overview of the most important aspects of the submission and the respective contact persons for the medicinal product and medical device sectors.
Submission of Approval Applications and Notifications
| Regulatory scope of clinical trials | Medicinal products | Medical devices |
|---|---|---|
| Legal basis | Radiation application in the context of a clinical trial within the meaning of Section 4 Subsection 23 of the Medicinal Products Act (Arzneimittelgesetz, AMG) | Radiation application in the context of a clinical trial within the meaning of Article 2 Number 45 of Regulation (EU) 2017/745 or in the context of another clinical trial within the meaning of Section 3 Number 4 of the Medical Device Law Implementation Act (Medizinprodukterecht-Durchführungsgesetz, MPDG) |
| Application portal | CTIS | DMIDS |
| Submission of application / notification for radiation application | With submission of the clinicial trial application in PART II (Section N_Suitability of Facility), CTIS | With submission of application / notification of other clinical trial |
| Further information on submission |
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Responsibilities and contact options
| Regulatory scope of clinical trial | Procedure type according to the Radiation Protection Act | Responsible for specifics of radiation applications | Contact content questions | Information on required documents regarding radiation application | Formally responsible for radiation applications |
|---|---|---|---|---|---|
| Medicinal product | Radiation application requiring approval (Section 31 StrlSchG) | BfS + responsible Ethics Committee | ePost@bfs.de | BfS - Application for authorisation (German only) | BfS |
| Medicinal product | Radiation application requiring notification (Section 32 StrlSchG) | responsible Ethics Committee | Overview Ethics Committees pursuant AMG | AK-EK - Radiation protection (German only) | BfArM or PEI pursuant to section 77 of the AMG |
| Medical devices | Radiation application requiring approval (Section 31 StrlSchG) | BfS + responsible Ethics Committee
| ePost@bfs.de | BfS - Application for authorisation (German only) | BfS |
| Medical devices | Radiation application requiring notification (Section 32 StrlSchG) | responsible Ethics Committee | Overview Ethics Committees pursuant MPDG | AK-EK - Radiation protection (German only) | BfArM |