Proposed amendments to EU Regulation on Medical Devices are counter to patients’ interests and unworkable, says ESHG

Recent amendments to the proposed Regulation on In Vitro Diagnostic Medical Devices (IVDs) currently before the European Parliament will restrict the rights of patients and doctors to carry out essential genetic testing, says the European Society of Human Genetics (ESHG) today (Monday 7 April 2014). Furthermore, an independent legal opinion now shows that the European Union (EU) has no competence to enact the Regulation as amended by the Parliament.

 

Please click here for the complete ESHG statement on the recent amendments to the proposed Regulation on In Vitro Diagnostic Medical Devices (IVDs).

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