Local view for "http://purl.org/linkedpolitics/eu/plenary/2012-06-14-Speech-4-332-000"
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"en.20120614.22.4-332-000"2
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"The PIP-breast implants scandal has brought to light the failure of the EU’s current system of certification of medical devices. Breast implants are classified as active implantable medical devices. In order for these to be placed on the market, in accordance with Directive 2007/47/EC, they have to fulfil three cumulative requirements: they must meet the requirements set by the legislation in force, they must bear the CE marking, and they must be subject to a compliance assessment by a health authority. The CE marking is therefore a prerequisite for placing medical devices on the market, and is also a guarantee of compliance with the applicable legislation, demonstrating that the medical device is safe and fit for purpose. It turns out that this whole process failed in the case of PIP breast implants and may have failed in many others, jeopardising the health of European citizens. It is therefore essential that the next review of the Medical Devices Directive establish a common procedure which first and foremost ensures the safety of medical devices and the absence of risks to the lives and health of patients."@en1
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