Apply for type approval of devices containing radioactive substances and installations generating ionizing radiation

If you want to manufacture devices containing radioactive substances or systems for generating ionizing radiation that may be operated without a license or notification, you can apply for a type approval.

The Federal Office for Radiation Protection (BfS) is responsible for issuing type approvals for devices containing radioactive materials and systems that generate ionizing radiation. If you acquire a type approval for a device or system, you can use it without a license or notification.

By granting the type approval, the BfS confirms that the tested prototypes meet the legal requirements for radiation protection. The type approval covers the entire design. No special approval or testing is required for individual devices anymore.

You submit your application for type approval for devices into which radioactive substances are incorporated, as well as for installations producing ionizing radiation, to the BfS.

Note:
The BfS grants the type approval for a maximum of 10 years. Upon application, you can have a granted type approval extended.

You must submit the application for type approval in writing to the Federal Office for Radiation Protection (BfS).

• You download the application forms from the BfS website and fill them out.
• You must select one or more experts to supervise the quality control. Experts are persons who possess knowledge and experience in radiation protection as well as knowledge of the structure and design of the device in question. They may belong to your own or other companies (e.g. TÜV) and must be independent in the exercise of their activity. Experts monitor that no device is placed on the market whose design deviates from the desired approval. You must notify the BfS of the experts and their qualifications when submitting the application.
• Please send the completed and signed application forms along with the remaining required documents by post, fax, or email to the BfS. You can send further documents by email or via a file transfer portal. The BfS will review your application. For devices containing radioactive substances, the Federal Institute for Materials Research and Testing (BAM) will be involved.
• If all requirements are met, the BfS grants the type approval and issues a type mark. The type approval certificate and the appointment of the experts will be sent to you by post in a notification from the BfS.

none

For processing your application for design approval, the Federal Office for Radiation Protection (BfS) and, where applicable, the Federal Institute for Materials Research and Testing (BAM) will charge fees.

• Federal Office for Radiation Protection: between EUR 2,000 and EUR 9,000, depending on the effort involved
• BAM: between 1,000 EUR and 3,000 EUR, depending on the effort

 
Under special conditions, an advance payment can be required.