French breast implant manufacturer PIP's decision to put dangerous gels in their products is one example of recent scandals involving medical devices. The European Parliament wants greater scrutiny on the industry. New legislation enforces stricter regulation and encourages innovation. In vitro diagnostic medical devices lead to better treatment and improve the health of EU citizens.
In a fateful turn for the medical industry, the PIP scandal exploded on the scene. The French breast implant manufacturer was accused of inserting a dangerous gel into the chests of nearly 400,000 women across the globe. The gel was made of industrial silicone. This is the same thing used in computers and car engines. In other words, this gel should not have been used in the implants and even less so in these women's bodies. Nevertheless the PIP company, the third-ranking producer of prosthetics in the world, had managed to get its products certified by a well-known notified body. When a company wants to bring a medical device to market, even a syringe or a breast implant, it must obtain certification, this is required by Europe. This means that the product must conform to specifications. A validated list which is checked by the certifying third party. A spate of similar medical scandals has encouraged the European Union to react to better define the legal framework governing medical devices. The goal of the medical devices regulation is primarily and absolutely to make sure that patients are safe. I think that there is another part of this story which is really important, we have a medical devices industry in Europe which is incredibly innovative. So we kept that in mind when we looked at this regulation to see if we could design a new piece of legislation that looked after patients and promoted innovation in the industry in a very safe way for all of us. The medical device industry is a major economic player in Europe, employing 575 000 people in the EU and achieving €100 billion per year in total sales. The goal of the new regulations is to protect this key sector and most importantly, the health of the many citizens that it serves. How do we do that? We are insisting under this regulation that notified bodies need to have the necessary skills so that they can do the job that they are being asked to do and that they also, in addition to the way they work now, carry out unannounced inspections. What we're talking about here is greater scrutiny, greater scrutiny and greater scrutiny. That's how the European Parliament wants to improve regulation in both medical devices and in vitro diagnostic devices that have an important place in our daily life. In vitro diagnostic medical devices are tests that help us to better detect and treat a disease. The IVD regulation is often seen as the little sister in the governance of medical products, but it is actually the mother. Because before doing therapy, an operation, using a drug or a medical product, I have to diagnose the patient correctly. And to do this, we need medical diagnostic devices, which also have to be improved. My view of this regulation is to rebuild trust and greater surveillance, and greater checks at every point in the chain, so that all of us will have access, now and in the future, to these incredible devices that save lives. Notice: Undefined offset: 0 in /var/www/api-beebox-wordbee/api/beebox/includes/ParserSrt.php on line 31 Notice: Undefined offset: 0 in /var/www/api-beebox-wordbee/api/beebox/includes/ParserSrt.php on line 31