The European Society of Radiology, as one of the founding members of the Alliance for MRI, welcomes the European Commission's announcement, made on October 26, that it will postpone and amend legislation which would pose a serious threat to the use of Magnetic Resonance Imaging (MRI) in patient welfare and scientific research.

The EU Physical Agents Directive 2004/40/EC (EMF) is to be delayed by four years until April 30, 2012 to allow time for a substantive amendment to be adopted. The Alliance welcomes the Commission's statement that "the future amendment will aim to ensure that limits will not have an adverse effect on the practice of MRI" and the recommendation to Member States to put the transposition of the current Directive on hold.

If implemented, the Directive would prevent healthcare staff from assisting or caring for patients during imaging. It would mean that some patients who cannot be imaged without this care - if they are young, elderly, frail or confused - would either be denied imaging or have to undergo alternative procedures such as X-rays.
"MRI is a powerful, non-invasive and safe diagnostic and research tool," says Professor Gabriel Krestin, a leading member of the Alliance for MRI and Professor of Radiology at Erasmus MC, University Medical Center Rotterdam, in the Netherlands. "However, its application often relies crucially on the presence of a healthcare worker or researcher. If the European Commission legislation were implemented, it would almost certainly impact on patient welfare and be a major setback for scientific research, denying patients innovative treatments in the future."

The Alliance for MRI believes that a derogation for MRI from the scope of the EU Physical Agents Directive 2004/40/EC (EMF) is necessary to ensure the future unimpeded use of MRI, particularly for cutting edge research and interventional MRI. It is essential that this major advance in healthcare technology is not threatened by burdensome legislation when concerns can be addressed through responsible guidance to medical and service personnel.

The safety of MRI workers is already regulated by the EU Medical Devices Directive (amend. Direct 93/42/EEC) and the established MR safety standard IEC/EN 60601-2-33 (as amended to include users/workers). The IEC standard establishes limit values for time-varying electromagnetic fields which have been set so that any danger to patients and workers is excluded.

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