Local view for "http://purl.org/linkedpolitics/eu/plenary/2012-06-13-Speech-3-607-000"
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"en.20120613.33.3-607-000"2
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"Madam President, Commissioner, ladies and gentlemen, it is clear that the PIP implants affair is not a simple case of national sanitary fraud. Unfortunately, we can see to what extent it is having, and will have, an impact at European and international level.
Allow me to give you some figures to illustrate the point. PIP implants were marketed in 71 countries worldwide. Some 400 000 breast implants were sold, affecting approximately 40 000 women in the United Kingdom, 30 000 in France and 10 000 in Spain. The Medical Devices Directive will be revised this autumn. We, as legislator, must learn from this fraud and strengthen our market surveillance and vigilance system for medical devices.
I lend my support to the proposals made by Thomas Ulmer and Philippe Juvin, the rapporteurs of the resolution on behalf of the Group of the European People’s Party (Christian Democrats), who apologise for being unable to be here this evening. I call on the Commission to take the following recommendations into consideration. We must strengthen and harmonise inspection obligations at Community level. Regular, unannounced, annual inspections need to be carried out urgently at all stages in the life of a medical device. The conditions of accreditation of notified bodies must be harmonised and the traceability, transparency and monitoring of medical devices placed on the European market must be strengthened.
Finally, I wish to draw your attention to a fundamental point: the need to find a balance between protecting our European patients and supporting innovation and research. We must bring together safety, transparency, consistency and flexibility. The first consistent approach is not to treat medical devices like medicinal products. There are three fundamental differences: a difference in nature, a difference in time to market, and a difference in terms of market flows.
Consequently, it is clear that the introduction of a market authorisation for the highest-risk medical devices would only result in administrative burdens, additional costs, longer times to market and, above all, it would stifle innovation. That is something that needs to be assessed depending on the case."@en1
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