Check your registration category

Reading time 5 min

Prerequisites

  • Your digital solution is a digital medical device
  • It has earned CE marking

Our advice

If you have multiple digital medical monitoring devices, identify the registration category for each one.

Before getting started

Select your registration category to access the appropriate steps for your solution.

The remote medical monitoring activity is based on a digital medical device without mentioning a trade name or company. The activity meets published minimum technical specifications and shared prescribing guidelines.


Read the documentation on the technical specifications for the different indications defined for generics at Registering as a brand name or generic: What are the differences?