Strasbourg - The European Parliament has drawn the consequences from scandals in the field of medical devices. These devices include a multitude of devices such as wooden spatulas, blood glucose and HIV tests or pacemakers. Over the course of the last years, there had been big difficulties for certain devices.

In one case, it was discovered that the French company PiP had marketed tens of thousands of harmful breast implants causing serious health damages to thousands of women. After the certification through a notified body the company had illegally exchanged high-quality medicinal silicone for inferior industry silicone. Recently, the notified body was judged not guilty in a process resulting from the issue as there had been no misconduct according to the legal situation of the time. "This shows that we have to adopt the legal situation," explains Dr. Peter Liese, spokesperson for health policy of the biggest group in the European Parliament (EPP-Christian Democrats). There have been similar problems concerning hip implants and HIV tests. "According to the Paul-Ehrlich-Institut, an agency that is subordinate to the German Ministry of Health, there was an HIV test on the market that showed wrong negative results more frequently than other tests. This means that, although there was an HIV virus, the test said there was none. We have to put an end to such cases of deception and sloppiness at the expense of the patients," Liese continues.

"The Parliament's decision today concerning medical device and IVD will substantially increase patient safety throughout Europe without creating unnecessary bureaucracy for the companies concerned," explains Liese. "In the future, there will be unannounced controls of already certified devices, a system of traceability for medical devices and an implant pass for patients. Furthermore, high-risk devices like pacemakers will only be certified by special notified bodies," Liese points out. However, Liese opposed the original plans of rapporteur Dagmar Roth-Behrendt for a central European authorization for all medical devices, an assessment by the European Medicines Agency (EMA) for certain medical devices and the introduction of 23 new expert committees. "These measures will not increase patient safety. A pre-market authorization is not per definition safer than authorization by notified bodies. In the field of pharmaceuticals, where such a system is already in place, we have scandals as well. Furthermore, the pre-market authorization system such as proposed is not adequate for medical devices due to the big number of new devices and the many innovations each year. For that reason, I am happy that these plans are off the table," the EPP health expert states.

In the field of In-Vitro Diagnostics, the most important issue from the point of view of consumer and patient safety is the informed consent clause for genetic tests. The new law stipulates that not only the quality of the tests themselves, but also the quality of information about the tests is improved. "I am very worried that there are companies that offer DNA tests on the internet with possibly very grave consequences. Today, we can tell an 18-year old person whether he or she will suffer an untreatable disease like Chorea Huntington (damage of the central nerve system) at 50. Such a diagnosis has dramatic consequences, not only psychologically but also for the dealings with insurances and employers.  For that reason, these tests should only be done after competent medical counseling. In Germany, France, Portugal, Austria and other countries we have very good laws for this, but many other countries in Europe have no rules at all. At a time where you can easily cross frontiers to receive medical services, we need European minimum standards," Liese underlines. Concluding, he calls upon the member states to quickly start negotiations about the final text: "The proposal has been on the table for 14 months. It is time to get more concrete. A further delay not only endangers patients' safety but also the planning reliability of the companies, mostly SMEs, working in this field. The patients expect us to pass a law before the European elections in May 2014. This should also be the goal for the member states, although they are not even close to having a common position."