Local view for "http://purl.org/linkedpolitics/eu/plenary/2012-06-13-Speech-3-612-000"

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"en.20120613.33.3-612-000"2
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"Madam President, ladies and gentlemen, the debate and the vote on the resolution come at a particularly propitious time because, if approved, the resolution can provide useful guidance for the medical device review. The breast implants issue has highlighted the deficiencies in the current system for certifying compliance with essential health and safety requirements. In my view, the review proposals from the European Commission and Commissioner Dalli rightly seek greater controls on medical device manufacturers and greater rigour from the competent authorities when issuing authorisations. I also agree with the need to avoid creating excessive bureaucracy that might block the use of innovative products for years. I believe that it is important to ensure rigorous, efficient and swift controls at European level. The thousands of women who have undergone breast implant surgery need to be made aware of the risks that they may face. They should be offered screening and medical advice to check for any damage and to prevent the implants from rupturing. It is important to set up a register to identify people who have been implanted with particular medical devices, so that information can be provided in good time if the devices need to be checked, altered or replaced. Introducing an ‘ID card’ for implants would enable users to obtain information about all the potential risks to which they may be exposed and which checks are advisable over time. It is vital, within a cooperative EU framework, that Member States make specific commitments to eliminate or minimise the recurrence of such serious events as that associated with the PIP silicone implants."@en1
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