In order to simplify the administrative procedure for radiation applications subject to notification in accordance with Section 32 of the Radiation Protection Act (StrlSchG) in the context of clinical investigations pursuant to the Medicinal Products Act (AMG) or Regulation (EU) 2017/745 on medical devices (MDR), the following will take effect on 1 July 2025

Change of responsibility:
Competence for the notification procedure in accordance with the Radiation Protection Act (StrlSchG) will be transferred from the Federal Office for Radiation Protection (BfS) to the competent federal higher authorities, i.e.:

• the Paul Ehrlich Institute (PEI) or
• the Federal Institute for Drugs and Medical Devices (BfArM),

depending on the competence in the relevant authorisation or approval procedure.

It therefore remains an official procedure. However, the Federal Office for Radiation Protection (BfS) will remain competent for radiation applications subject to authorisation in accordance with Section 31 StrlSchG.

Combined radiation applications:
If both radiation applications subject to notification and approval are planned as part of a clinical investigation, a single approval procedure must be carried out at the BfS. The procedure cannot be split and submitted separately.

Further information on selecting the appropriate procedure is available on the BfS website:
https://www.bfs.de/DE/themen/ion/anwendung-medizin/forschung/antragstellung-ab-1-7/antragstellung-ab-1-7_node.html.

Procedure from 1 July 2025 (single-gate principle):
From 1 July 2025, notifications of intended use of ionising radiation must be submitted via the electronic system applicable to the respective procedure:

• CTIS (Clinical Trials Information System) for procedures under the AMG,
• DMIDS (German Medical Devices Information and Database System) for procedures under the MPDG.

The notification of the use of radiation is an integral part of the respective procedure and is submitted at the same time as the application or notification for clinical investigation. A suspension of the deadline in one procedure also suspends the deadline in the other procedure, so that they remain synchronised. Despite the procedural link, the procedure under radiation protection law and the review procedure under medicinal product or medical device law remain legally independent.

For procedures under the Medical Devices Implementation Act (MPDG), the notification is integrated into the sequential review procedure.

Formal requirements:
The application/notification for clinical investigation must contain an explicit reference to the notification under radiation protection law in the cover letter. In the DMIDS, the field provided for this purpose must be selected in the application form.

Competence of the Ethics Commission:
The substantive assessment of the notification regarding the use of radiation is carried out exclusively by the Ethics Commission competent under the AMG or MPDG. The latter issues a clear written statement, which is forwarded to both the applicant and the competent federal higher authority.

The federal higher authority is bound by the opinion of the Ethics Commission in its decision. It does not carry out any independent assessment of the content of the radiation application. Any requirements, restrictions or prohibitions on the reported radiation application will be communicated in an official decision.

Start of the indicated application:
The indicated use of radioactive substances or ionising radiation on humans may only commence if

1. approval has been granted or is deemed to have been granted for the clinical investigation or substantial modification of a clinical investigation in accordance with the AMG, or
2. the clinical investigation in accordance with the MDR, the other clinical investigation in accordance with the MPDG may commence or a substantial modification of the aforementioned investigations may be carried out. 

Subsequent amendments to a notified radiation application

From 1 July 2025, amendments to radiation applications already notified in accordance with Section 32 of the Radiation Protection Act (StrlSchG) that are carried out as part of clinical investigations in accordance with the German Medicinal Products Act (AMG), Regulation (EU) 2017/745 on medical devices (MDR) or the Medical Devices Implementation Act (MPDG), must be reported in the course of the respective notification of amendment in accordance with the AMG, MDR or MPDG.

This new regulation also applies to radiation applications subject to notification in the context of clinical studies that were submitted to the Federal Office for Radiation Protection (BfS) before 1 July 2025.

Requirements for the notification of amendments:

• The cover letter accompanying the notification of amendment must clearly indicate that the planned change also affects the use of radiation.
• All amendments to the use of radiation must be clearly and comprehensively identified.

Procedure (like the initial notification):

• Notification of amendments to the use of radiation is carried out within the existing amendment notification procedure for clinical investigation.
• Despite procedural links in the sense of the ‘single gate’ approach, the radiation protection procedure and the procedure under medicinal product or medical device law remain legally independent of each other.
• The substantive assessment of the notification of amendment is carried out exclusively by the competent ethics committee.
• The deadlines for the procedures involved (e.g. under the AMG or MPDG and under the StrlSchG) are coordinated with each other. A suspension of the deadline in one procedure automatically applies to the other.
• The federal higher authority is bound by the opinion of the Ethics Commission and does not carry out its own review of the use of radiation.

Start of the notified substantial amendment to the use of radiation:
The notified use of radioactive substances or ionising radiation on humans may only commence if

1. approval has been granted or is deemed to have been granted for the clinical investigation or substantial amendment to a clinical investigation in accordance with the German Medicinal Products Act (AMG), or
2. the clinical investigation in accordance with the MDR, an other clinical investigation in accordance with the MPDG may commence or a substantial amendment to the aforementioned investigations may be made.