Following the PIP scandal concerning breast implants, Commissioner Dalli of the European Commission took the initiative of a resolution.
This resolution was passed in the European Parliament plenary session of this June 14th. 
On this basis, a recommendation and a regulation are being drafted by Commission experts. This recommendation and this Regulation should be approved in late 2012 for entry into force early 2013.
They would imply
     - Increased surveillance of notified bodies with a revision of the scope of their notification in accordance with their internal skills. That could to imply that some manufacturers will be forced to change their notified bodies because their bodies would no longer be authorized to issue certificates for their type of medical device.
    - The establishment of unannounced inspection visit by your notified body. It should be required to pay an additional unannounced visit at each manufacturer by period of 3 years.
 

Françoise Schlemmer