Local view for "http://purl.org/linkedpolitics/eu/plenary/2012-06-14-Speech-4-330-468"
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"en.20120614.22.4-330-468"2
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"The fraud perpetrated by the Poly Implant Prothèse company has brought to light a lack of cooperation between Member States and the international community in terms of information sharing and notification of adverse effects, and the failure of the current compliance-certification system as regards key health and safety requirements. This motion for a resolution, for which I voted, urgently recommends a revision of the Medical Devices Directive, aimed at introducing a capacity to detect and minimise the risk of fraud. The Member States should carry out rigorous inspections of the devices associated with the greatest risks at least once a year. It calls on the Commission to develop an appropriate legal framework to guarantee the safety of breast implants and of medical technology in general. It advocates improving the functioning of the vigilance system for medical devices, by facilitating and actively encouraging patients, patients’ associations, patient groups and healthcare professionals to report all adverse events and harmful effects to the competent authorities. The Commission and the Member States should step up their cooperation within the existing legal framework, in particular in the fields of market surveillance, vigilance and inspection."@en1
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