Transitioning to the New MDD – What to Expect From the Notified Body

The revised MDD comes into full effect on March 21, 2010. Note that although there is no transition period per se, this date applies to any individual product that has a CE mark applied on or after March 21, 2010. Therefore, even though previously approved by a Notified Body, product lines that continue to be manufactured after March 20, 2010 must meet the new directive.

Manufacturers currently selling devices into the EU must be aware of actions their NB may take when reviewing existing products for conformity to the new directive, when submitting new devices for approval, or submitting changes to devices.