The issuance by the EEAE of the initial special operating licence for MRI laboratories involves the following steps:

1. Feasibility licence, which is granted by the competent Regional Governor following the favourable opinion of the Ministry of Health’s Committee on Ionising and Non-Ionising Radiation.

Interested parties shall submit an application to the Health Directorate of the relevant Region, stating the purpose for which the feasibility permit is sought.

The feasibility licence is valid for one (1) year from the date of issue.

2. Preliminary construction approval, issued by the EEAE. Interested parties must submit an application to the EEAE, accompanied by the following supporting documents:

• Feasibility permit
• Plan and sectional drawings of the electromagnetically shielded room (Faraday cage) on a scale of 1:50, showing the isomagnetic lines with isotropic static magnetic field intensities H015: 15 mT, H010:10 mT, H05:5 mT, H03:3 mT, H00.5:0.5 mT and H00.1:0.1 mT, the laboratory areas and adjacent spaces, the locations of the equipment and peripheral systems, the special protective measures and the shielding.
• A radiation protection study of premises and shielding prepared by the radiation protection officer, which describes in detail the construction of the laboratory to ensure compliance with the requirements regarding:(a) magnetic shielding; (b) radio-frequency shielding; (c) insulation against acoustic noise; and (d) the cryogen (helium) escape route, if required

The EEAE accepts studies and technical data provided by the manufacturers or installers of magnetic resonance imaging (MRI) scanners, provided that these have been assessed and approved by the radiation protection officer. This acceptance is documented either by a relevant statement from the radiation protection officer or by references to, or the attachment of, such data to the radiation protection study submitted to the EEAE. The radiation protection officer who drew up the study is required to supervise the construction of the laboratory, and in particular the planned shielding, and is responsible for ensuring that the laboratory is constructed in accordance with the approvedradiation protection study.

The EEAE checks the completeness and accuracy of the supporting documents submitted and subsequently grants preliminary construction approval.

3. Special operating licencefrom a radiation protection perspective, issued by the EEAE.

Upon completion of the laboratory’s construction, the licence holder submits to the EEAE an application for the issue of a special operating licence for the laboratory, together with the following:
– 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.
– Supporting documents for the scientific director (licence to practise, specialism and registration with the Medical Association).
– Supporting documents for the radiation protection officer (licence to practise outside the field of ionising radiation)

– List of staff, academic qualifications, training certificates and assignment of practical aspects of exposure.

   – Radiation protection report concerning non-ionising radiation (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 protocols, 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 on the condition of the equipment, accompanied by a manufacturer’s certificate 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 building housing the MRI laboratory complies with the requirements for earthquake protection and sound insulation.
– A certificate from the fire service or a solemn declaration by the applicant stating that the fire safety conditions for the laboratory premises are met.

The EEAE, following an assessment of the above supporting documents, and provided that it is established that all conditions regarding safe operation and protection against non-ionising radiation are met, it issues the certificate of suitability and subsequently the special operating licence. If the EEAE considers that the supporting documents and information provided are insufficient, it may request additional information or amendments to the details in the supporting documents submitted, which will support and supplement the information provided.

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