An amendment to the special operating licence for MRI laboratories is required in the following cases:

I. Changes to equipment
a. Addition of equipment: to add new equipment to an existing MRI laboratory, the procedure applicable to the issuance of the special operating licence for MRI laboratories.
Note: the laboratory’s supporting documents that have already been submitted to the EEAE and are currently valid (designated doctor, staff list, etc.) do not need to be resubmitted.

b. Equipment replacement: for the replacement of an MRI system within the same laboratory premises with another system of the same or higher magnetic field strength (T), no new feasibility authorisation is required. However, prior construction approval is required, and the procedure applicable to the prior construction approval of MRI laboratories must be followed.

Upon completion of the laboratory’s construction, the licence holder shall submit to the EEAE an application to amend the laboratory’s specific operating licence, together with the following supporting documents:

• A statutory declaration by the licence holder confirming the completion of the laboratory’s construction.
• A statutory declaration by the scientific director and the radiation protection officer of the MRI laboratory, confirming that the laboratory was constructed in accordance with the preliminary construction approval.
• Radiation protection report covering non-ionising radiation (for staff, patients, the general public and premises) and safe operation, drawn up by the radiation protection officer (for staff, patients and premises), which takes into account the radiation protection, safety and quality protocols for imaging systems, and includes procedures for dealing with accidents or incidents and any emergency situation, as well as measurements and assessments of magnetic field strength and acoustic noise levels both inside and outside the laboratory premises.
• A statement regarding the condition of the equipment, accompanied by a declaration from the equipment manufacturers regarding the service life of systems and spare parts, and a certificate of CE marking for the equipment
• A statutory declaration by the licence holder that the previously installed system has been removed from the laboratory

If the EEAE deems that the supporting documents and information provided are insufficient, it may request additional information or amendments to the details in the submitted supporting documents, which will corroborate and supplement the information provided. The EEAE then assesses the supporting documents submitted and proceeds to amend the specific operating licence.

II. Changes to the scientific officer or radiation protection officer

• In the event of a change to the scientific officer or radiation protection officer, the licence holder shall submit an application to the EEAE for the amendment of the laboratory’s special operating licence, together with the following supporting documents:

• Supporting documents for the scientific officer (professional licence, specialism and registration with the Medical Association)
• Supporting documents for the radiation protection officer (copy of the licence to practise outside the field of ionising radiation)

The EEAE then assesses the supporting documents submitted and proceeds to amend the special operating licence.

II. Changes to the licence holder

• In the event of a change to the company name or the legal representative (without a change to the Tax Identification Number), the licence holder must submit an application to amend the special operating licence with the updated details, accompanied by a certificate of changes from the General Commercial Registry (GEMI) or, in the case of a public body, from the Government Gazette (FEK). The new licence, which is issued with a validity period equal to the remaining validity of the previous one, shall contain the updated details.
• In the event of a change to the laboratory’s details accompanied by a change to the Tax Identification Number (AFM), applications* must be submitted by both the new and the current licence holder, a statutory declaration by the new licence holder confirming that the conditions under which the licence was granted to the previous laboratory have not changed, and the articles of association of the new company.

The new licence, issued with a validity period equal to the remaining term of the previous licence, shall contain the updated details of the new laboratory.

Supporting documents must be submitted by email to the following addresses: adeies@eeae.gr. The documents submitted must be digitally signed.

*Sample text of an application for amendment. 
I request the amendment of Decision No. ………. (Special Operating Licence) decision of the EEAE from the aforementioned laboratory to the laboratory …….. (name) with Tax Identification Number ……”