Local view for "http://purl.org/linkedpolitics/eu/plenary/2012-06-13-Speech-3-613-000"
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"en.20120613.33.3-613-000"2
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"Madam President, during the last 20 years, the medical device regulatory system has, overall, provided for safe, reliable and performing devices in Europe and has provided the flexibility needed for the high number of medical devices and the short life cycle of these products. It has also proven to be a system that is cost-effective and SME-friendly. It has put Europe in the forefront of innovation.
This is where I believe that the transparency of the market should be enhanced, by giving all interested parties the right information not only – as Ms McAvan has said – about costs and benefits, but also about the duration, durability and consequences of the implants or whatever other device they are using, because this is not only a question of implants and there are other devices in use.
I believe everybody needs to know all the implications of using such devices, because some people really do think that once they go through a procedure, it is a once in a lifetime procedure, which, in many instances, is not the case. This has to be continuously put in front of our patients, or our consumers, in the way we are suggesting. These cards have to be given to every single patient who undergoes any type of procedure involving such implants. In this way, patient awareness will be greatly improved.
I do believe that the set of measures already foreseen, combined with additional measures deemed necessary in the light of the result of the stress test, will considerably reinforce the system, favour innovation and ensure that only safe and performing medical devices are placed on the European market, for the benefit of European citizens. I have taken note of the points raised by Ms Auconie and I must say that all her points are, in fact, included in the proposal that we will be presenting, as I said, just after the summer.
For months before the PIP case, the Commission was reviewing the Medical Devices Directive, because we found that it needed quite a number of improvements. The PIP case is indeed appalling. It is a case of fraud which went undetected due to weaknesses in the post-market phase. Nevertheless, the case has highlighted a number of weaknesses in the regulatory framework.
In order to provide a rapid answer to European patients’ concerns, I have identified, and shared with the European Parliament, a number of actions to be taken immediately, together with the Member States, on the basis of the current legislation. This includes tightening market controls, in order to provide a better guarantee of the safety of medical technology, especially high risk devices. I have therefore written to the Health Ministers of all the Member States to ask for their support, and together we are now putting these actions in place.
For the longer term, the revised medical device legislation that the Commission has been preparing – independently of the PIP case, as I said – will also take on board the experiences of this affair. The Commission intends to adopt its proposal shortly after the summer break.
A number of improvements were already foreseen to reinforce the system. These improvements will contribute to avoiding cases like the PIP implant case. To mention but a few: we want to strengthen the designation, monitoring and functioning of notified bodies and ensure that this is carried out in accordance with the same high standards across the EU; and we want a stronger role to be given to competent authorities, both in pre- and post-market phases.
The system can only be efficient if we make the best use of the limited number of experts available. This is why the Commission foresees a pre-market scrutiny mechanism to be put in place for high-risk devices, and other devices where necessary, but on a case by case basis. This mechanism will allow a committee composed of Member States’ experts to check certain notified bodies’ assessments before the devices can have access to the market.
The advantage of doing so will be twofold. First, it will ensure an equal level of assessment by notified bodies, in particular, with regard to clinical evidence. Second, it will allow Member States to be informed of products coming onto the market so that they can ensure targeted controls of these products. This mechanism has the advantage that scarce resources and expertise are used to ensure efficient and proportionate pre-market control and reinforced vigilance and market surveillance. Last but not least, we want to improve the traceability requirements for medical devices, for instance, by means of a unique device identification and a single registration system.
Following the PIP case, the Commission performed a ‘stress test’ of the medical device legislation in order to identify additional possible shortcomings of the regulatory framework and address them in the context of the upcoming revision. As a result of the stress test, additional measures will be included in the Commission proposal.
These proposals will concern the audit activities of the notified bodies. Particular attention will be paid to the obligatory unannounced visits to the manufacturer, testing of products and rotation of auditors. Information will be given to national authorities with regard to negative outcomes of such audits. Measures should also be put in place to enhance the reporting of incidents by health care professionals and patients. Patients’ awareness should also be improved through, for example, implant cards providing appropriate information."@en1
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