CE-marking
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.
