This important vote represents another major, laudable step forward in the right direction. The European Parliament approved the postponement with a clear majority. Following the positive vote in the Parliament, the next major step in the legislative procedure will be the vote at the Council of Ministers, which is expected at the end of February.
The Directive will be delayed by four years until 30th April 2012 to allow time for a substantive amendment to be adopted. Prior to a proposal being adopted, the European Commission will be undertaking a comprehensive impact assessment of the Directive and a broad stakeholder consultation. The Alliance for MRI and its members look forward to contributing to this process.
The Alliance for MRI remains concerned, however, that a number of member states have proceeded with transposition of the Directive, and calls on the European Commission to address this situation.
The current published Directive prevents healthcare staff from assisting or caring for patients during MR imaging. As a result, 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.
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 MR-guided interventions. 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 and 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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Related news articles:
- Alliance for MRI Welcomes Postponement and Amendment of the EU Directive
- European Society of Radiology launches "Alliance for MRI"
Background on Alliance for MRI
The Alliance is supported by:
- 26 Members of the European Parliament
Jan Andersson (PES) SE, John Bowis (EPP/ED) UK, Philip Bushill Matthews, (EPP/ED)UK, Jorgo Chatzimarkakis (ALDE), DE, Harald Ettl (PES) AT, Robert Goebbels, (PES) LU, Stephen Hughes, (PES) UK, Ville Itälä (EPP/ED) FI, Anneli Jäätteenmäki, (ALDE) FI,Karin Joens (PES) DE, Piia-Noora Kauppi, (EPP/ED) FI, Eija-Riitta Korhola, (EPP/ED) FI, Peter Liese (EPP) DE, Elizabeth Lynne, (ALDE) UK, Jules Maaten, (ALDE) NL, Linda McAvan (PES)UK, Dr Angelika Niebler (EPP/ED) DE, Ria Oomen-Ruijten, (EPP/ED) NL, Antonio Panzeri Pier, (PES) IT, Frédérique Ries (ALSE)BE, Zuzana Roithová (EPP/ED) CZ, Jean Spautz, (EPP/ED) LU, Hannes Swoboda (PES) AT (Founding member), Thomas Ulmer (EPP/ED) DE , Anne Van Lancker (PES) BE, Dr Anja Weisgerber (EPP/ED) DE
- European and National patient groups European Federation of Neurological Associations (Founding member); including the European Parkinson's Disease Association, The European MS Platform and the European Headache Alliance, The European Heart Network, Europa Donna, The European Patients Forum, The International Diabetes Federation Europe, Alzheimer Europe, The WHO Collaborative Centre for Research, training and treatment in Epilepsy, The Austrian Lung Association, The Austrian Epilepsy Association, Werkgroep Hersentumoren vzw (Belgian Brain Tumour Group), Epilepsy Centres of the Netherlands Foundation: SEIN
- Representative Groups of Scientists
- European Society of Radiology (Founding Member) and institutional members (below)
- The Wellcome Trust
- European Society for Magnetic Resonance in Medicine and Biology (ESMRMB)
- European Union of Medical Specialists
- European Brain Council
- Luxembourg Medical Council
- European Institute for Biomedical Imaging Research (EIBIR)
- The Society and College of Radiographers
- European Society for Therapeutic Radiology and Oncology (ESTRO)
- European CanCer Organisation (ECCO)
- Société Française de Radiologie (SFR)
- Spanish Radiological Society (SERAM)
- Polish Medical Society of Radiology
- Norwegian Society of Radiology
- Royal Belgian Radiological Society
- Luxembourg Society of Radiology
- Deutsche Roentgengesellschaft - German Radiological Society (DRG)
- Radiological Society of the Netherland s
- European Society of Urogenital Radiology (ESUR)
- European Society of Thoracic Imaging (ESTI)
- European Society of Neuroradiology (ESNR)
- Croatian Medical Association & Croatian Society of Radiology
- European Society of Cardiac Radiology (ESCR)
- Italian Society of Radiology (SIRM)
- European Society of Breast Imaging (EUSOBI)
- Romanian Society of Radiology
- Danish Society of Radiology
- Austrian Radiologic Society (ÖRG)
- British Institute of Radiology
- Swedish Society of Medical Radiology
- Bulgarian Association of Radiology
- Sociedade Portuguesa de Radiologia e Medicina Nuclear
- Czech Radiological Society
- Faculty of Radiologists, Royal College of Surgeons in Ireland
- European Society of Head and Neck Radiology
- Cardiovascular and Interventional Radiological Society of Europe
- The Royal College of Radiologists
- In addition, a number of individual scientists and patient group representatives have signed up to the Alliance