The route to CE marking depends on the risk classification of your device and also on how many you manufacture. The development of a device is heavily regulated and various criteria need to have been checked and decisions/design routes justified and recorded.
The Manufacturers or their authorised representative must follow one of several routes in order to CE mark their devices and legally sell or distribute them on the European market.
The Brand owner for the device will also have some of the responsibilities of the manufacturer.
The Team at Design Cognition have been involved in many successful device developments and understand what is required to develop a device/product that will meet the stringent criteria laid down by the various authorities. We can provide support for your project from concept through development, authorisation and commercialisation or even for the reviews. We are here to help, so give us a call!