Brussels, 09/02/2012 (Agence Europe) - John Dalli, European Commissioner for Health and Consumers, urged member states on Thursday 9 February to take immediate action at national level in order to ensure that European legislation in force regarding medical devices is fully applied, in the wake of the PIP breast implant scandal. Pending review of European legislation to be proposed “before the summer break”, “there are a number of measures which … need to be taken sooner rather than later”, Dalli explained. After publication of a report by the scientific committee last week, he called on that committee to conduct a more in-depth examination of the possible consequences on health of the faulty implants, based on information made available by member states. The SCENIHR report had concluded that the risks for the health of persons wearing the PIP implants was not at this stage higher than for persons wearing other breast implants (see EUROPE 10545). “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”, Dalli said.
Henceforth, it will be a priority for the member states and the European Commission to step up controls, to provide better guarantees regarding the safety of medical devices, and to restore patient confidence. Dalli has outlined his proposals in a letter sent to member state health ministers. Measures are to be implemented as rapidly as possible, and ministers are called upon to give their full cooperation in implementing the suggested plan. The measures are to be put into effect this year as part of the legislation currently in force. They relate to heightened surveillance of the market to ensure the safety of medical devices, particularly those that may present a high risk. In particular, the actions proposed include the following:
verification of the designations of notified bodies to ensure that they are designated only for the assessment of medical devices and technologies that correspond to their proven expertise and competence;
guarantee that all notified bodies in the context of the conformity assessment make full use of their powers under the current legislation which includes the power to conduct unannounced inspections:
reinforced market surveillance by national authorities, in particular spot checks in respect of certain types of devices;
improved functioning of the vigilance system for medical devices for example by giving systematic access for notified bodies to reports of adverse events; encouraging healthcare professional and patients to report problems;
and support for the development of tools ensuring the traceability of medical devices as well as their long-term monitoring in terms of safety and performance, such as unique device identification systems and implant registers.
At the same time, the Commission continues its review of the directive on medical devices in which it will include results of stress tests set in place to identify shortcomings on which light was shed in the PIP case. (IL/transl.jl)