Betrieb oder wesentliche Änderung des Betriebs einer zahnmedizinischen, medizinischen und tiermedizinischen Röntgeneinrichtung anzeigen

If you intend to operate or substantially modify a dental, medical or veterinary X-ray facility and it is not subject to authorisation, you are obliged to report this to the competent authority.

By notifying a dental, medical or veterinary X-ray facility in writing, you are announcing that you intend to operate or substantially modify such a facility.

You must submit the notification in writing to the competent authority at least four weeks before the intended start date. After the expiry of this period, the X-ray equipment may be operated, unless this is prohibited.

The legal requirements must be met. The necessary documents must be submitted for this purpose.

The application can be submitted online or in paper form.

In addition to the application for notification, the following documents must be submitted:

• 1. a copy of the certificate issued by an official expert, including the test report;
• 2. Certificate of approval for the design of the X-ray emitter (optional)
• 3. proof that the number of radiation protection officers necessary for the safe operation of the X-ray facility has been appointed and that they have been granted the powers necessary for the performance of their duties;
• 4. proof that each radiation protection officer has the necessary specialist knowledge or, if a radiation protection officer is not necessary, that the radiation protection officer has the necessary expertise in radiation protection
• 5. proof that the persons otherwise involved in the operation of the X-ray facility possess the necessary knowledge and skills with regard to the possible radiation hazard and the protective measures to be applied

In addition, in the case of an X-ray device for use on humans, proof that the following requirements are met

1. the applicant or the radiation protection officer appointed by him or her is licensed as a doctor or dentist or is permitted to practise the medical or dental profession temporarily

2. Ensure that:

(a) in the case of treatment with radioactive substances or ionising radiation, which is not based on an individual treatment plan (standardised treatment), and in the case of an examination with radioactive substances or ionising radiation, which may involve significant exposure of the person being examined, an expert in medical physics may be called in to assist, or

b) in the case of all other applications involving ionising radiation or radioactive substances on humans, it is ensured that a medical physics expert can be consulted for advice, insofar as this is required by the respective application

3. it is ensured that a medical physics expert is appointed as an additional radiation protection officer in the event of treatment or examination in accordance with a) if this is necessary for organisational or radiation protection reasons

4. it is ensured that a sufficient number of personnel necessary for the safe performance of the activity is available

In addition, in the case of an X-ray device for use on animals in veterinary medicine, proof that the following requirements are met

1. The applicant or the radiation protection officer appointed by him is licensed as a veterinarian, doctor or dentist or is entitled to practice the profession of veterinarian, medical or dental on a temporary basis.

After the expiry of the four-week period, you may operate the X-ray facility, provided that the procedure has not been suspended or the operation prohibited for reasons of failure. If the authority informs you in writing that all evidence has been provided, you may operate the X-ray facility as soon as you receive the notification.

You may be prohibited from operating or substantially altering your business if:

1. you do not or no longer meet one of the requirements to be demonstrated; this shall only apply after the expiry of the deadline if a remedy is not remedied within a reasonable time

2. There are facts from which doubts arise as to the reliability of the person responsible for radiation protection or the radiation protection officer

3. there are facts which give rise to doubts as to the availability of the necessary staff to carry out the work safely

4. the type of activity is unjustified, or if there are serious doubts as to the justification of the type of activity

5. the provisions of this Act or the ordinances issued pursuant to this Act or the orders and orders of the supervisory authorities based thereon are seriously or repeatedly violated and remedy is not remedied within a reasonable time

6. this is necessary due to a significant risk to employees, third parties or the general public

7. other provisions of public law preclude the intended activity.

The same applies in the event of a significant change in the operation of an X-ray facility.

The fee is calculated according to the time spent, but is at least 150 euros.

• You submit the notification in writing to the competent authority. In it, you explain whether it is the operation or a significant change to a dental, medical or veterinary X-ray facility.
• You set the display before you put the X-ray equipment into operation or make significant changes.
• After the four-week period has elapsed, you may operate the X-ray facility or make significant changes to it, provided that the authority has not suspended the procedure or prohibited its operation.
• If the authority informs you in writing that all evidence has been provided, you may operate the X-ray facility as soon as you receive the notification.
• Finally, you will be sent a notice of costs from the competent authority.

The information on legal remedies can be found in the decision of the competent authority.

• Operation of an X-ray facility or significant change of operation Acceptance for dental, medical or veterinary X-ray facilities
• The operation of a dental, medical or veterinary X-ray facility must be reported
• The significant change in the operation of an X-ray facility must be indicated
• The notification must be notified in writing at least four weeks before the intended start date
• The operation or the substantial modification must not take place before the expiry of the specified period

In some cases, the operation of an X-ray facility may be subject to approval and may require another online service

• The application can be submitted online or in paper form.