The European Union recently decided to place stricter regulations on medical devices after hundreds of thousands of women worldwide received below standard silicone implants made by the French company Poly Implant Prothese (PIP). This silicone-based scandal was partly due to lax EU safety regulations that had done little to scrutinize the 80 national ad hoc agencies that were monitoring medical devices. When compromised, the implants had been known to cause inflammation to body tissues. The implants were made of a cheaper material that had not been approved for medical use, and were rupturing at a rate that was double the industry average.

EU health commissioner John Dalli submitted a proposal that encompassed what was learned from the PIP scandal and would also include the addition of a scrutiny panel, which would monitor the assessments made by the various national agencies. Dalli further mentioned that the panel would have the ability to “pick out medical devices on certain risk-based criteria to decide whether to go into an in-depth analysis of the processes.” In addition to the aforementioned proposed changes, there is also a proposal to expand the legal definition of medical devices to include breast and other aesthetic implants.

There are differing opinions regarding the proposed increase of medical device regulations. Serge Bernasconi, the chief executive of Ecumed, an industry body that represents nearly 22,500 medical technologies in Europe, argued that the regulations that were already in place were more than sufficient and provided a “high level of safety” for patients without causing a delay that would deny them access to life saving technologies. He further argued that by implementing such regulations would effectively stifle European innovation and research to other countries that do not have such regulations, thereby also causing harm to patients.

On the other hand, it is argued by the European Consumer Organisation (also known as BEUC) that the proposed regulations are not going to be strict enough and medical devices should have to undergo the same process as pharmaceutical products. The head of BEUC, Monique Goyens, contends that there is an imbalance regarding the levels of protections afforded to a patient based on whether they “have an artificial heart valve or take medicine for diabetes.” This idea was addressed in a press release made by the European Commission, it was stated that medical devices should not be confused with medicinal products. The distinct difference between the two is that medical devices have a physical principal mode of action. In other words it can serve as a physical barrier or replace support to organs or bodily functions, etc.

The press release further illustrates the proposed changes in regulations to include: clearer rights and responsibilities for manufacturers, better traceability of devices, an adaptation of general health and safety requirements, and a creation of a Medical Device Coordination Group.With these changes, the independent assessment agencies will be provided with more power to monitor the medical devices, including the ability to make unannounced inspections of factories and regular product testing. Because of this increase in power, the EU governments will have to provide better supervision of their agencies.

This proposed legislation is unlikely to occur for two more years, due to the process of needing to be approved jointly by EU governments and lawmakers.

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