首页
登录
职称英语
The European Commission said on Thursday it would toughen the regulation of
The European Commission said on Thursday it would toughen the regulation of
游客
2023-11-17
20
管理
问题
The European Commission said on Thursday it would toughen the regulation of medical devices as a result of concerns raised by breast implants produced by the defunct French company PIP, even as a scientific expert review it ordered concluded there was currently "insufficient evidence" that women using its products faced greater health risks than others.
John Dalli, health and consumer policy commissioner, pledged to examine surveillance and operation of the "notified bodies" that scrutinise medical devices across the EU in a current review of legislation, stressing: "The capacity to detect and minimise the risk of fraud must be increased."
His comments followed an official report released on Wednesday in France that called for national and EU-wide co-operation including random inspections and sampling of medical devices to prevent a repeat of the fraudulent use of substandard non-medical-grade silicone by PIP in implants sold to up to 400,000 women around the world.
Xavier Bertrand, France’s minister of health, called for enhanced action in France and across Europe in the wake of the study, which highlighted that Afssaps, the French medical regulator, did not inspect PIP from 2001 until a tip-off led officials to inspect and close down the company in 2010. Jean-Claude Mas, its founder, is under police investigation for manslaughter.
Mr. Bertrand has pledged to hire more health inspectors and undertake random checks on medical device companies following growing concerns over its regulatory system highlighted by the widespread use of PIP’s substandard breast implants.
A French decision at the end of last year to offer all women free removal of PIP implants triggered similar proposals in the UK, Germany and the Czech Republic and has helped spark a fresh debate over tougher EU regulation of medical devices, which are subject to far less scrutiny than pharmaceuticals.
However, a review released on Thursday by the EU’s own Scientific Committee on Emerging and Newly Identified Health Risks concluded: "Breast implants can fail, regardless of manufacturer, and the probability of failure increases with time since implantation. In most cases, breast implant failure appears to be without identifiable health consequences for the patient with the exception of possible local complications."
It stressed that limited data meant that while there was no link between breast implants and cancer, there was a need for further work to understand the specific risks from the PIP products.
Mr. Bertrand has endorsed calls for a parliamentary inquiry in France as well as a report from the country’s social affairs inspectorate, mirroring similar moves that led to tough new requirements for the pharmaceutical industry introduced last year in the wake of concerns about Servier’s drug Mediator.
Medical device manufacturers have called for reforms to ensure that the national "notified bodies" which audit the quality of their products across Europe are of a consistently high standard, while cautioning that tough new regulatory requirements could harm the EU’s competitive advantage.
The French study showed that Afssaps had received multiple warnings over the relatively high failure rate of PIP implants compared with those made by other companies, even though the overall proportion remained modest.
From Financial Times, February 2, 2012 [br] According to the passage, "notified bodies" in Paragraph 2 are responsible for______.
选项
A、proposing legislation, implementing decisions in European Union
B、producing and marketing the medical devices across the EU
C、providing some scientific advice to the European Commission
D、assessing whether a product meets certain preordained standards
答案
D
解析
本题为语义题。根据第二段“…‘notified bodies’that scrutinise medical devices…”和倒数第二段“‘notified bodies’which audit the quality of their products…”可知D正确;A是European Commission的职责;B是制药公司的职责;C是Scientific Committee on Emerging and Newly Identified Health Risks的职责。
转载请注明原文地址:https://tihaiku.com/zcyy/3193973.html
相关试题推荐
ThedisputebetweentheEuropeanUnionandtheUnitedStatesismainlyabout[br
ThedisputebetweentheEuropeanUnionandtheUnitedStatesismainlyabout[br
AbreakthroughintheprovisionofenergyfromthesunfortheEuropeanEco
Inthe1920sdemandforAmericanfarmproductsfell,asEuropeancountries
Inthe1920sdemandforAmericanfarmproductsfell,asEuropeancountries
Inthe1920sdemandforAmericanfarmproductsfell,asEuropeancountries
TheEuropeanUnionhadnotapprovedanumberofgeneticallymodifiedcropsu
TheEuropeanUnionhadnotapprovedanumberofgeneticallymodifiedcropsu
TheEuropeanUnionhadnotapprovedanumberofgeneticallymodifiedcropsu
TheEuropeanUnionhadnotapprovedanumberofgeneticallymodifiedcropsu
随机试题
技术编辑的主要职责包括( )等。A.承担科技类书稿的编辑加工 B.研究选择特
倡导简约适度、绿色低碳的生活方式,反对奢侈浪费和不合理消费,开展创建节约型机关(
下列说法中,正确的是()。①在《圣经·旧约》的记载中,带领以色列入走出埃及、回
下面是喷泉实验的创新设计: ②制取氨气:图1中.从橡胶塞和圆底烧瓶接缝
企业自用房地产或存货转换为采用公允价值模式计量的投资性房地产时,转换当日的公允价
以下措施能预防产褥期泌尿系感染的是A.待产时尽量憋尿 B.大小便后及时从后向前
C提取第一组图形中前两个图形相同的部分为第三个图形,根据这一规律,可知第二组图形中的第三个图形为C项。
根据《国家赔偿法》的规定,国家不承担赔偿责任的是()。A.警察在追捕犯罪嫌疑
必须在取得国家商务主管部门的许可后,才能经营进口列入国家公布的禁止进口目录以及其
引起急性出血性结肠炎的病原体是A.新型肠道病毒70型 B.伤寒沙门菌 C.大
最新回复
(
0
)