MRI Exception to Directive on Exposure to Electromagnetic Fields Approved

medtechinsiderJuly 4, 2013 – 2:02 am – The European Council of Employment and Social Policy Ministers has approved an exception for MRI to the directive Protecting Workers from Exposure to Electromagnetic Fields. The original draft version would have prevented MRI from being used in certain diagnoses and treatments, such as MRI-guided surgery, and also would have severely restricted new research and development, according to the Alliance for MRI, which issued a statement welcoming the approval. The safety of MRI already is ensured through the safety standard IEC/EN 60601-2-33, the alliance pointed out.

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Medical Device Regulations Draft: MEPs Propose more than 900 Amendments

Medical Device Regulations Draft - MEPs Propose more than 900 AmendmentsJune 12, 2013 – The new medical device regulations might change significantly from the original draft report proposed by the European Commission or the version introduced by Rapporteur Dagmar Roth-Behrendt. This became clear as the Committee on the Environment, Public Health and Food Safety (ENVI) debated the device regulations and MEPs added their amendments to the regulations last month. Not only were there more than 900 amendments; there were also several different amendments to the same clauses in some cases, according to life science lawyer Erik Vollebregt. In addition, Roth-Behrendt and IVD regulation Propel Rapporteur Peter Liese added amendments to each other’s proposals. It seems that the only thing everyone can agree on is that there needs to be more oversight over notified bodies.

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