Effective July 1, 2025, new regulations will apply to radiation protection approvals or notifications for clinical trials.

The use of radioactive substances or ionizing radiation for medical research purposes (hereinafter referred to as “radiation applications”) may be subject to approval in accordance with Section 31 of the Radiation Protection Act (Strahlenschutzgesetz, StrlSchG) or notification in accordance with Section 32 StrlSchG.

Until now, the Federal Office for Radiation Protection (Bundesamt für Strahlenschutz, BfS) had to review the application for approval or notification in a separate procedure in Germany. Of July 1, 2025, the application or notification of the radiation application will be submitted in the same way as the clinical trial itself is applied for. This means that the single-gate approach applies. CTIS is used for clinical trials of medicinal products in accordance with Regulation (EU) 536/2014. The German Medical Devices Information and Database System (DMIDS) is used in the context of a clinical trial within the meaning of Article 2(45) of Regulation (EU) 2017/745 (Medizinprodukteverordnung, MDR) or in the context of other clinical trials within the meaning of Section 3(4) of the Medical Devices Implementation Act (Medizinprodukterecht-Durchführungsgesetz, MPDG).

The objectives of the reform of the Radiation Protection Act by the Medical Research Act (Medizinforschungsgesetz, MFG) are to harmonize and interlink radiation protection law with both pharmaceutical and medical device regulations. In the notification procedure, there is no double review by the BfS and the ethics committee. In clinical trials with medicinal products, the BfS and the ethics committee review the procedure in parallel in a procedure requiring approval. This speeds up the procedure.

Important: The procedures under radiation protection law and under medicinal product or medical device law remain legally independent procedures.

Notification or approval?

The most important prerequisites for a research project to be classified as notifiable are

• The safety or efficacy of a treatment procedure is being tested
• The use of radiation as such is not itself the subject of research
• The use of radiation is a recognized standard procedure for investigating humans
• Only patients with a disease whose treatment is being investigated as part of the research project may be included. This means that as soon as the research project is carried out on healthy individuals, it is subject to approval.
• A new feature is that minors may also be included in the research project. This applies as long as the total effective dose from all radiation applications carried out as part of the research project is not expected to exceed 6 millisieverts per person.
• The research project is
• a clinical trial within the meaning of Section 4 (23) of the German Medicinal Products Act (Arzneimittelgesetz, AMG),
• a clinical trial within the meaning of Article 2 (45) of Regulation (EU) 2017/745 (MDR) or
• any other clinical trial within the meaning of Section 3(4) of the Medical Devices Implementation Act (Medizinprodukterecht-Durchführungsgesetz, MPDG).

Conclusion

Any use of radiation for medical research purposes that is not subject to notification is subject to approval (Section 31(1) StrlSchG).

These include

• research projects involving healthy individuals
• research projects involving minors in which the total radiation exposure resulting from the study exceeds 6 millisieverts per person
• Research projects that are neither clinical trials pursuant to Section 4 (23) of the AMG or Article 2 (45) of Regulation (EU) 2017/745 (MDR) nor other clinical trials within the meaning of Section 3 (4) of the Medical Devices Implementation Act (MPDG). This radiation application for medical research purposes must be approved by the BfS in accordance with professional law (Berufsrecht) pursuant to Sections 31 et seq. of the StrlSchG.