At Congenius we look to provide reassurance through knowledge. In addition to the services we provide our customers, every six weeks, we will be publishing a fact sheet on a timely MedTech topic. First up, is our quick guide to De Novo Registration. Download the fact sheet below to read about what the De Novo classification process is, when a De Novo registration is required, what you should include in your De Novo request, and guidance on timings and fees involved.