Local view for "http://purl.org/linkedpolitics/eu/plenary/2012-06-14-Speech-4-335-968"

Predicate	Value (sorted: default)
rdf:type	lpv_eu:Speech2
dcterms:Date	"2012-06-14"^^xsd:date2
dcterms:Is Part Of	lp_eu:Explanations of vote2
dcterms:Language	"pt"^^xsd:language2
lpv:document identification number	"en.20120614.22.4-335-968"2
lpv:hasSubsequent	lp_eu:2012-06-14-Speech-4-336-2502
lpv:speaker	lp:Paulo Rangel2
lpv:spokenAs	vice-chair; EPP (2009-11-25--2014-06-30)3 substitute; Delegation to the EU-Russia Parliamentary Cooperation Committee (2009-09-30--2014-06-30)3 unknown; Partido Social Democrata (2009-07-14--2014-06-30)3 member; Delegation for relations with the United States (2009-09-16--2014-06-30)3 member; AFCO (2012-01-19--2014-06-30)3 substitute; JURI (2012-01-19--2014-06-30)3
lpv:translated text	"This resolution follows the investigation into the French manufacturer Poly Implant Prothèse for the fraudulent use of low-quality materials, namely industrial silicone, different from the material indicated in the documents submitted for conformity assessment, namely approved medical-grade silicone. The fraud has brought to light a flaw at European and national level in terms of the lack of cooperation between the Member States and the international community with regard to information sharing and notification of adverse effects, as well as the lack of traceability of the raw material used for medical devices. It is therefore intended that the Member States step up their cooperation within the existing legal framework, in particular in the fields of market surveillance, vigilance and inspection, and to tighten controls, in order to provide a better guarantee of safety of patients, especially those exposed to high-risk medical devices."@en1

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