European Commission
Press Release
September 26, 2012
Ranging from simple sticking plasters to the most sophisticated life-supporting machines, medical devices and in vitro diagnostic medical devices are central to our health and quality of life. To ensure that these devices serve the needs and ensure the safety of European citizens, the European Commission today proposed two Regulations which are fit for purpose, more transparent and better adapted to scientific and technological progress. The new rules aim to ensure that patients, consumers and healthcare professionals can reap the benefits of safe, effective and innovative medical devices. The medical device sector is highly innovative, particularly in Europe and has an estimated market value of around €95bn 1.
Health and Consumer Policy Commissioner John Dalli said “Just a few months ago, everybody was shocked by the scandal involving fraudulent breast implants which affected tens of thousands of women in Europe and around the world. As policy makers, we must do our best never to let this happen again. This damaged the confidence of patients, consumers and healthcare professionals in the safety of the devices on which they rely every day. The proposals adopted today significantly tighten the controls so as to ensure that only safe devices are placed on the European Union’s market at the same time, they foster innovation and contribute to maintaining the competitiveness of the medical device sector…”