There are an ever-increasing number of ‘medical device’ products coming to market or existing products changing their classification to ‘medical device’ to give greater flexibility in the market. The boundary between Medical Devices and packaging is becoming ever-more blurred as the followng areas converge: smartphone technology, materials technology, internet capabilities & bandwidth, Wi-Fi and Near Field Communications (NFC). This is particularly evident in the area of patient compliance (adherence) and to a lesser extent, also in the areas of anti-counterfeiting and Track & Trace.

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!

Chris Penfold

Tags: biotech, compliance, counterfeit, Design, device, healthcare, Innovation, material, medical, medicaldevice, packaging, pharma, Technology

This entry was posted on Friday, March 11th, 2011 at 6:04 pm and is filed under Design, Healthcare & Pharma, Innovation, Materials, Medical Devices, Technology. You can follow any responses to this entry through the RSS 2.0 feed. Responses are currently closed, but you can trackback from your own site.