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PARALLEL TEXTS
Dispositivi medici più sicuri, efficaci e innovativi
Inglese tratto da:http://europa.eu/rapid/pressReleasesAction.do?reference=IP/12/1011&format=HTML&aged=0&language=EN&guiLanguage=en
Italiano tratto da:
http://europa.eu/rapid/pressReleasesAction.do?reference=IP/12/1011&format=HTML&aged=0&language=IT&guiLanguage=en
Data documento: 26-09-2012
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Safer, more effective and innovative medical devices
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Dispositivi medici più sicuri, efficaci e innovativi
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Ranging from simple sticking plasters to the most sophisticated life-supporting machines, medical devices and in vitro diagnostic medical devices are central to our health and quality of life.
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Dalla semplice medicazione adesiva alle macchine più sofisticate che permettono di mantenere le funzioni vitali, i dispositivi medici e i dispositivi medici per la diagnostica in vitro sono essenziali per la nostra salute e la qualità della nostra vita.
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To ensure that these devices serve the needs and ensure the safety of European citizens, the European Commission today proposed two Regulations which are fit for purpose, more transparent and better adapted to scientific and technological progress.
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Affinché questi dispositivi rispondano alle esigenze sanitarie e garantiscano la sicurezza dei cittadini europei, la Commissione ha proposto oggi due regolamenti adeguati agli obiettivi fissati, più trasparenti, e che tengono meglio conto dei progressi scientifici e tecnici.
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The new rules aim to ensure that patients, consumers and healthcare professionals can reap the benefits of safe, effective and innovative medical devices.
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Le nuove norme hanno lo scopo di garantire che i pazienti, i consumatori e i professionisti della salute possano trarre vantaggio da dispositivi medici sicuri, efficaci e innovativi.
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The medical device sector is highly innovative, particularly in Europe and has an estimated market value of around €95bn .
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Il settore dei dispositivi medici è estremamente innovativo, particolarmente in Europa, ed ha un valore di mercato di circa 95 miliardi di EUR.
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Health and Consumer Policy Commissioner John Dalli said "Just a few months ago, everybody was shocked by the scandal involving fraudulent breast implants which affected tens of thousands of women in Europe and around the world.
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Il Commissario per la salute e la politica dei consumatori, John Dalli, ha dichiarato "Solo pochi mesi orsono, lo scandalo delle protesi mammarie difettose, che ha coinvolto decine di milioni di donne in Europa e nel mondo, ha provocato un'onda di shock nell'opinione pubblica.
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As policy makers, we must do our best never to let this happen again.
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In quanto legislatori, dobbiamo fare del nostro meglio affinché ciò non si ripeta mai più.
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This damaged the confidence of patients, consumers and healthcare professionals in the safety of the devices on which they rely every day.
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Questo scandalo ha intaccato la fiducia dei pazienti, dei consumatori e dei professionisti nella sicurezza dei dispositivi che utilizzano quotidianamente.
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The proposals adopted today significantly tighten the controls so as to ensure that only safe devices are placed on the European Union's market at the same time, they foster innovation and contribute to maintaining the competitiveness of the medical device sector."
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Le proposte adottate oggi intendono rafforzare sensibilmente i controlli per garantire che solo i dispositivi sicuri siano commercializzati nell'Unione europea e, allo stesso tempo favorire l'innovazione e preservare la competitività del settore dei dispositivi medici."
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Who will benefit?
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Chi sono i beneficiari?
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- Patients and consumers since all devices will have to undergo thorough assessment of safety and performance before they can be sold on the European market.
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- I pazienti e i consumatori, poiché tutti i dispositivi devono essere oggetto di una rigorosa valutazione delle loro caratteristiche in materia di sicurezza e di prestazioni, prima di poter essere commercializzati sul mercato europeo.
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Control processes are radically reinforced, but continue to ensure rapid access to innovative, cost-effective devices for European patients and consumers.
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Le procedure di controllo saranno radicalmente rafforzate, ma continueranno a consentire ai pazienti e ai consumatori europei di accedere rapidamente a dispositivi innovativi con un buon rapporto costo/efficacia.
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- Healthcare professionals will be provided with better information on the benefits for patients, residual risks and the overall risk/benefit ratio, helping them make the best use of medical equipment in their treatment and care of patients.
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- I professionisti della salute, che saranno meglio informati sui benefici per i pazienti, sui rischi residui e in generale sul rapporto rischi/vantaggi, consentendo loro di utilizzare al meglio le attrezzature mediche nei trattamenti e nelle cure impartiti ai pazienti.
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- Manufacturers will benefit from clearer rules, easier trading between EU countries and a level playing field that excludes those who do not comply with the legislation.
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-i fabbricanti, che trarranno vantaggio da regole più chiare, da scambi commerciali facilitati tra i paesi dell'UE e da condizioni di concorrenza equa che escludano dal mercato gli operatori che non rispettano la normativa.
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The new rules support patient-oriented innovation and take particular account of the specific needs of the many small and medium-sized manufacturers in this sector.
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Queste nuove regole favoriranno l'innovazione incentrata sui pazienti e tengono particolarmente conto delle esigenze specifiche di numerose PMI del settore dei dispositivi medici.
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Main elements of the proposals include:
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I principali elementi delle proposte:
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- Wider and clearer scope of EU legislation, extended to include, for example, implants for aesthetic purposes, and clarified for instance, as regards medical software.
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- Il campo di applicazione per la legislazione dell'Unione è ampliato, ad esempio alle protesi con finalità estetica, e chiarito, ad esempio per quanto riguarda i software medici.
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This will ensure that the safety and performance of these products are correctly assessed before they are placed on the European market;
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La sicurezza e le prestazioni di questi prodotti saranno in tal modo correttamente valutati prima della commercializzazione sul mercato europeo;
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- Stronger supervision of independent assessment bodies by national authorities;
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- la sorveglianza degli organismi di valutazione indipendenti da parte delle autorità nazionali è rafforzata;
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- More powers and obligations for assessment bodies, to ensure thorough testing and regular checks on manufacturers, including unannounced factory inspections and sample testing;
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- i poteri attribuiti agli organismi di valutazione sono rafforzati, così come gli obblighi che incombono loro, per garantire che i fabbricanti siano oggetto di valutazioni rigorose e di controlli regolari, in particolare mediante ispezioni senza preavviso e prove a campione;
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- Clearer rights and responsibilities for manufacturers, importers and distributors, applying also to diagnostic services and internet sales;
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- i diritti e le responsabilità dei fabbricanti, degli importatori e dei distributori saranno ulteriormente chiariti, anche per quanto riguarda i servizi diagnostici e la vendita online;
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- Extended database on medical devices, providing comprehensive and public information on products available on the EU market.
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- la base di dati sui dispositivi medici è ulteriormente sviluppata e contiene informazioni esaustive ed accessibili al pubblico sui prodotti disponibili nel mercato dell'Unione.
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Patients, healthcare professionals and the public at large will have access to the key data concerning medical devices available in Europe, allowing them to make better informed decisions;
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I pazienti, i professionisti della salute e il pubblico in generale potranno consultare i principali dati riguardanti i dispositivi medici disponibili in Europa e prendere decisioni con piena conoscenza di causa;
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- Better traceability of devices throughout the supply chain, enabling a swift and effective response to safety concerns.
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- viene migliorata la tracciabilità dei dispositivi lungo tutta la catena di approvvigionamento, e ciò consentirà di reagire rapidamente ed efficacemente a qualunque problema di sicurezza.
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A Unique Device Identification system will be introduced to enhance post-market safety of medical devices, to help to reduce medical errors and to fight against counterfeiting;
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L'introduzione di un sistema unico d'identificazione dei dispositivi permetterà di migliorarne la sicurezza dopo la commercializzazione, contribuendo a ridurre il numero di errori medici e a lottare contro le contraffazioni;
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- Stricter requirements for clinical evidence, to ensure patient and consumer safety;
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- i requisiti relativi alle prove cliniche sono rinforzati per garantire la sicurezza dei pazienti e dei consumatori;
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- Adaptation of the rules to technological and scientific progress, for example the adaptation of the safety and performance requirements applicable to new health technologies, such as software or nanomaterials used in healthcare;
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- le norme applicabili sono adeguate ai progressi tecnologici e scientifici, così come le prescrizioni in materia di sicurezza e di prestazioni applicabili alle nuove tecnologie della salute, come i software e i nanomateriali;
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- Better coordination between national surveillance authorities, to ensure that only safe devices are available on the European market;
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- viene migliorato il coordinamento tra le autorità nazionali di sorveglianza per garantire che siano disponibili nel mercato europeo solo dispositivi sicuri;
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- Alignment to international guidelines, to facilitate international trade.
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- gli orientamenti internazionali sono presi in considerazione allo scopo di facilitare gli scambi internazionali.
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The revised regulatory framework for medical devices is comprised of the following:
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Il quadro regolamentare rivisto relativo ai dispositivi medici comprende:
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- A proposal for a Regulation on medical devices (to replace: Directive 90/385/EEC regarding active implantable medical devices and Directive 93/42/EEC regarding medical devices);
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- Una proposta di regolamento relativo ai dispositivi medici (in sostituzione della direttiva 90/385/CEE relativa ai dispositivi medici impiantabili attivi e della direttiva 93/42/CEE relativa ai dispositivi medici);
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- A proposal for a Regulation on in vitro diagnostic medical devices (to replace Directive 98/79/EC regarding in vitro diagnostic medical devices).
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- Una proposta di regolamento relativo ai dispositivi medico-diagnostici in vitro (in sostituzione della direttiva 98/79/CE relativa ai dispositivi medico-diagnostici in vitro). |
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LISTEN WITH READSPEAKER
Safer, more effective and innovative medical devices
Ranging from simple sticking plasters to the most sophisticated
life-supporting machines, medical devices and in vitro diagnostic medical
devices are central to our health and quality of life.
To ensure that these devices serve the needs and ensure the safety of
European citizens, the European Commission today proposed two Regulations which
are fit for purpose, more transparent and better adapted to scientific and
technological progress.
The new rules aim to ensure that patients, consumers and healthcare
professionals can reap the benefits of safe, effective and innovative medical
devices.
The medical device sector is highly innovative, particularly in Europe
and has an estimated market value of around €95bn .
Health and Consumer Policy Commissioner John Dalli said "Just a few
months ago, everybody was shocked by the scandal involving fraudulent breast
implants which affected tens of thousands of women in Europe and around the
world.
As policy makers, we must do our best never to let this happen again.
This damaged the confidence of patients, consumers and healthcare
professionals in the safety of the devices on which they rely every day.
The proposals adopted today significantly tighten the controls so as to
ensure that only safe devices are placed on the European Union's market at the
same time, they foster innovation and contribute to maintaining the
competitiveness of the medical device sector."
Who will benefit?
- Patients and consumers since all devices will have to undergo
thorough assessment of safety and performance before they can be sold on the
European market.
Control processes are radically reinforced, but continue to ensure
rapid access to innovative, cost-effective devices for European patients and
consumers.
- Healthcare professionals will be provided with better information on
the benefits for patients, residual risks and the overall risk/benefit ratio,
helping them make the best use of medical equipment in their treatment and care
of patients.
- Manufacturers will benefit from clearer rules, easier trading between
EU countries and a level playing field that excludes those who do not comply
with the legislation.
The new rules support patient-oriented innovation and take particular
account of the specific needs of the many small and medium-sized manufacturers
in this sector.
Main elements of the proposals include:
- Wider and clearer scope of EU legislation, extended to include, for
example, implants for aesthetic purposes, and clarified for instance, as regards
medical software.
This will ensure that the safety and performance of these products are
correctly assessed before they are placed on the European market;
- Stronger supervision of independent assessment bodies by national
authorities;
- More powers and obligations for assessment bodies, to ensure thorough
testing and regular checks on manufacturers, including unannounced factory
inspections and sample testing;
- Clearer rights and responsibilities for manufacturers, importers and
distributors, applying also to diagnostic services and internet sales;
- Extended database on medical devices, providing comprehensive and
public information on products available on the EU market.
Patients, healthcare professionals and the public at large will have
access to the key data concerning medical devices available in Europe, allowing
them to make better informed decisions;
- Better traceability of devices throughout the supply chain, enabling
a swift and effective response to safety concerns.
A Unique Device Identification system will be introduced to enhance
post-market safety of medical devices, to help to reduce medical errors and to
fight against counterfeiting;
- Stricter requirements for clinical evidence, to ensure patient and
consumer safety;
- Adaptation of the rules to technological and scientific progress, for
example the adaptation of the safety and performance requirements applicable to
new health technologies, such as software or nanomaterials used in healthcare;
- Better coordination between national surveillance authorities, to
ensure that only safe devices are available on the European market;
- Alignment to international guidelines, to facilitate international
trade.
The revised regulatory framework for medical devices is comprised of
the following:
- A proposal for a Regulation on medical devices (to replace: Directive
90/385/EEC regarding active implantable medical devices and Directive 93/42/EEC
regarding medical devices);
- A proposal for a Regulation on in vitro diagnostic medical devices
(to replace Directive 98/79/EC regarding in vitro diagnostic medical devices).
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