Local view for "http://purl.org/linkedpolitics/eu/plenary/2012-06-14-Speech-4-330-437"

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	"fr"^^xsd:language2
lpv:document identification number	"en.20120614.22.4-330-437"2
lpv:hasSubsequent	lp_eu:2012-06-14-Speech-4-330-5002
lpv:speaker	lp:Sophie Auconie2
lpv:spokenAs	member; EPP (2009-07-14--2014-06-30)3 unknown; Nouveau Centre (2009-07-14--2013-05-26)3 substitute; ECON (2012-01-19--2014-06-30)3 member; Delegation to the EU-Former Yugoslav Republic of Macedonia Joint Parliamentary Committee (2009-09-16--2014-06-30)3 substitute; Delegation to the EU-Mexico Joint Parliamentary Committee (2009-09-16--2014-06-30)3 member; ENVI (2012-01-19--2014-06-30)3
lpv:translated text	"Following the PIP breast implants scandal, we have voted in favour of establishing a register, stricter controls and traceability for these implants, and pre-market authorisation. I spoke in plenary on this subject. Unfortunately, this situation has had and will have an impact on a European and international scale. Around 40 000 women were affected in the United Kingdom, 30 000 in France and 10 000 in Spain. As legislators, we must learn from this fraud and strengthen the surveillance and vigilance system for medical devices. We must strengthen and harmonise mandatory inspections at EU level. We need to urgently put in place regular, unannounced, annual controls at all stages of the life cycle of a medical device. We must harmonise accreditation conditions for notified bodies and strengthen the traceability, transparency and monitoring of medical devices on the European market. A balance must be found between protecting our European patients and supporting innovation and research. We must combine safety, transparency, coherence and flexibility."@en1

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