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John Dalli

Commissioner for Health and Consumer Policy

Commissioner Dalli calls for immediate actions concerning the safety of medical devices

Statement in the press room of the Berlaymont

Brussels, 09 February 2012

Good morning ladies and gentlemen,

I am here today to talk to you about improving patient safety in the wake of the PIP breast implant incident.

Safety is central to my policy as Commissioner for Health and Consumers. I have just come from the hearing in the European Parliament on the future Consumer Agenda and there again I emphasised the importance I accord to the safety of consumer products and services, to better enforcement of the rules intended to protect us and to empowering consumers, ensuring they are better informed and able to articulate their concerns and address shortcomings.

And, as you know, I take the same approach to patient safety. I am deeply concerned about the potential health impact for the many women, in Europe and in other parts of the world, who received faulty silicone breast implants manufactured by the French company PIP. The consequences for their health are still uncertain.

For this reason I have asked an EU Scientific Committee, following the presentation of their first opinion last week, to conduct further in-depth studies to provide guidance on the potential health impact of the PIP implants.

But we also need to look at the sector of medical devices as a whole.

As you know, we had already been working on a revision of the Medical Devices legislation and within the context of the ongoing preparatory work we had included provisions, among others, on the strengthened supervision of notified bodies, clinical investigations, vigilance and traceability. I remain committed to presenting the Commission's legislative proposals before the summer break.

The adoption and entry into force of the new legislation, however, will inevitably take some time. But we, Member States and the Commission, have a duty vis-à-vis our citizens to do the utmost, within the existing legal framework, to tighten up controls. We must act together to provide a better guarantee of the safety of medical technology, especially implantable and other high risk devices, and to restore patient confidence in the system.

I have therefore again today written to the Health Ministers of all 27 Member States outlining a plan of immediate actions that we (Member States and Commission) can together implement on the basis of the existing legislation in the course of the next twelve months.

There are a number of measures which, I believe, need to be taken sooner rather than later. Let me list some of them:

Firstly, all Member States, EFTA countries and Turkey, which is covered by a free trade agreement, must ensure that the requirements to be met by the independent notified bodies that are involved in the pre-market assessment of medical devices are rigorously and consistently applied:

    I have asked the Health Ministers to revisit, within the coming months, the scope of designation of all those notified bodies which they are currently able to carry out conformity assessments for high-risk devices;

    At the same time, the Commission will work on detailed implementing measures to amplify the criteria set out in the current directives for this designation, and ensure that Member States take a consistent approach;

Secondly, all notified bodies will be required to make full use of the powers given to them under the current directives. Unannounced inspections of the manufacturers' premises are an important aspect of what can already be done now.

Thirdly, I have asked the Member States to reinforce their market surveillance activities which would include spot checks in respect to certain types of devices which could also include testing of products. In order to avoid duplication and to join forces, the Commission stands ready to help with the coordination of such actions. We might even consider something akin to a sweep, such as we carry out in the consumer area.

Fourthly, we need to improve the functioning of the vigilance system for medical devices:

    Notified bodies should have access to incident reports so that they can assess their impact on the certificates they have issued;

    Moreover, we will press for a more co-ordinated analysis of adverse incidents reported by Member States, so that EU-wide problems can be detected and addressed more quickly;

    I have also asked the Health Ministers to ensure that healthcare professionals do in fact report adverse events and to empower the patients to do so as well. We cannot only rely on the reporting by manufacturers.

Finally, I suggest that we can already start to develop tools ensuring the traceability of medical devices and their longer term monitoring in terms of safety and performance:

    The Commission intends to provide guidance to the Member States that are in the process of establishing systems of Unique Device Identification (UDI) to ensure that these systems are compatible with each other and with the future European UDI system which we are planning as part of the future legislation;

    The Commission supports initiatives aiming at an effective collection of mid- and long-term data on the safety and performance of implantable medical devices, such as implant registers set up in cooperation with the medical professional societies.

I have asked my colleagues in the Member States for their personal commitment to implementing these actions as a matter of priority. I know that we all subscribe to the need to put patients first and to restore trust in our regulatory system.

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