The Commission is proposing amendments to regulations in the medical devices sector and is inviting the public to comment on its draft proposal.
Medical devices are currently regulated under three directives covering respectively active implantable medical devices, medical devices and in vitro diagnostic medical devices. Due to technical differences between them, the directives will not be merged, but the Commission wants a coherent EU regulatory framework and an effective implementation for the sector to maintain the highest level of public confidence.
“The medical device sector is an area where society and citizens directly benefit from innovation and technological progress. Our proposal aims to improve coherence, transparency and effectiveness of the relevant legislation,” said Commission Vice-President Günter Verheugen.
The European market for medical device technology is the world’s second largest after the United States.
Interested parties have until 20 June 2005 to submit their comments by e-mail.