Current Edition

Dealing with Medical Device Regulations

In 2008, the European Commission initiated a public
consultation on existing requirements covering medical
devices, which produced more than 200 comments and
proposals for change from a wide variety of stakeholders.
As a result, the European Commission released, in
2012, its plan to restructure the EU’s medical device
regulatory framework, along with a regulation that would
replace existing directives for medical devices and active
implantable medical devices. In this article, Richard Poate
from TUV SUD explains the need to comply with the latest
regulatory requirements, or risk products being withdrawn
from the market.