EU Directive on Electromagnetic fields (EMF)
June 22nd 2011
The European Commission has issued this 14/06 a proposal for revising the Directive 2004/40/EC on electromagnetic fields (EMF) and introduced an exemption for MRI from the binding exposure limits proposed in the new directive.
The derogation is part of a wide-ranging update of the directive, which the European Parliament and Council are expected to act on later this year. The derogation for MRI is required as the revised exposure limits still curtail the use of MRI in areas such as MRI-guided surgery, imaging vulnerable patients and children. New research and developments in MRI would also be severely restricted, as would routine cleaning and maintenance of MRI equipment.
“This proposal is good news for patients around Europe, and we look forward to its quick adoption, which will clarify the law on MRI,” said Hannes Swoboda, a leading Member of the European Parliament and founding Member of the Alliance for MRI (a coalition of MEPs, patients groups and scientists, of which the EHN is a member).
“This proposal ensures that patients across Europe will be able to receive the highest standard of care and will not be forced into the undesirable alternative of x-rays. We very much hope that the Polish Presidency will seek early agreement in Council particularly given their commitment to brain disease where MRI is a key tool for diagnosis and treatment” said Mary Baker, leading Patient Group Advocate and President of the European Brain Council.
The directive proposal corrects the unforeseen negative impact on magnetic resonance imaging of the previous directive, which will be important for Europe as a whole.
”Europe is currently at the forefront of this technology and with this revision the Commission demonstrated that it supports this vital technology,” said Dr. Gabriel Krestin, Vice-President of the European Society of Radiology.
The new proposal is part of the European Commission health and safety legislation to protect workers. MRI will be exempt from the exposure limit values of the directive but workers using MRI will be protected through existing regulations, which ensure its safe use. The established MR safety standard IEC/EN 60601-2-33 defines criteria for minimizing physiological effects due to exposure to time-varying electromagnetic fields, aiming to eliminate danger to patients and workers. The Alliance for MRI also supports other qualitative measures proposed in the directive and the adoption of guidelines to ensure working practices are in line with technological developments.