Consultation opened on new medical devices

摘要

Is it necessary to broaden EU legislation on medical devices incorporating new technologies? Should cosmetic implants and the like be regulated at EU level, for example, and do so for the benefit of public health while favouring the sector's innovation and competitiveness? These are some of the questions that the European Commission is asking professionals from the sector who have until 2 July to respond. Launched by Industry Commissioner Gtinter Verheugen, on 8 May, this exercise is supposed to respond to his strategy to reduce and simplify EU legislation adopted by the Commission in 2005. The commissioner had committed to do this for medical devices in order to "better protect public health". "Experience indicates that the current system does not always offer a uniform level of protection of public health in the European Union," stresses the Commission in a press release. As the sector is highly dynamic, new and emerging technologies challenge the current EU safety framework of three main directives, from the 1990s, and six modifying directives.