In Europe, CE-marking is a legal requirement in the interests of patient safety. Medical devices cannot be marketed without a CE label. Companies wishing to market a medical device in Europe must first undergo, and successfully complete conformity assessment procedure. In most instances, this requires the participation of a Notified Body. The label consists in this case of the CE logo together with the four-digit code number issued by the Notified Body concerned. ecm is officially notified by the European Commission under ID No. 0481.

ecm’s services as a Notified Body are provided for the following products:

  • non-implantable medical devices
  • non-active, implantable medical devices
  • wound care products
  • dental products
  • medical devices utilizing animal tissues or derivates
  • medical devices with pharmacogically active components

Up-to-date information on the scope of our Notification is provided here.