Louise Zornoza reports on Raps.org that on September 24, 2013, the European Commission issued new rules creating a new EU process for designating and monitoring Notified Bodies. The new rules establish the basis for withdrawal and clarify the required expertise of these groups. Notified Bodies are responsible for the oversight of local manufacturers of medium and high risk medical devices. There are currently 80 Notified Bodies in the European Union, which all conduct audits and issue CE markings for medical devices. The new rules describe the designation of a Notified Body as well as the monitoring of such body to reaffirm its compliance and use. For the full article and new rules, click here.
