Local view for "http://purl.org/linkedpolitics/eu/plenary/2017-04-04-Speech-2-427-000"

Predicate	Value (sorted: default)
rdf:type	lpv_eu:Speech2
dcterms:Date	"2017-04-04"^^xsd:date2
dcterms:Is Part Of	lp_eu:Medical devices - In vitro diagnostic medical devices (debate)2
dcterms:Language	"en"^^xsd:language2
lpv:document identification number	"en.20170404.22.2-427-000"2
lpv:hasSubsequent	lp_eu:2017-04-04-Speech-2-428-0002
lpv:speaker	lp:Seán Kelly2
lpv:spoken text	"Mr President, medical devices cover a wide array of products, from sticking plasters to heart valves, to analytical laboratory equipment; all in all, about 500 000 devices in the EU market. The proposals here mainly focus on scrutiny of devices before they are placed on the market and their surveillance after becoming available as well as their traceability and the supply chains, and this is highly commendable. Proposals include stricter criteria for designating and monitoring notified bodies, adaptation of classification rules and streamlining of different assessment procedures. We must ensure a high level of health and safety protection for EU citizens using these products and must adapt the EU legislation to the significant technological and scientific progress in this sector over the last 20 years. I believe that with this text these goals will be achieved and I commend the rapporteurs Willmott and my colleague, Liese on their significant work in this regard. With this work, we will see stricter requirements for notified bodies who check the conformity of these products. This is important for consumers who rely on them for ensuring the highest standards for these products in the EU. Strengthened rules for high-risk devices are also welcome, as is the guidance and expertise to be provided by expert panels and laboratories on this issue. This is also important to ensure the utmost safety of products on the market. I am pleased with the inclusion of the enhanced system of traceability of devices along with post-market surveillance. I welcome the setting up of a central database. A good job well done by the rapporteurs."@en1
lpv:spokenAs	substitute; Committee of Inquiry to investigate alleged contraventions and maladministration in the application of Union law in relation to money laundering, tax avoidance and tax evasion (2016-06-24--2017-12-13)3
lpv:unclassifiedMetadata	"Seán Kelly (PPE )."1
lpv:videoURI	<go to Events_and_structure europarl>2

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