Check my registration type
Reading time 5 min
Prerequisites
- Your digital solution is a digital medical device
- It is CE marked
Our advice
If you are in possession of several digital telemonitoring medical devices, identify the type of registration for each.
Before you start your journey
Select your registration type to access the implementation path tailored to your solution.
The remote medical monitoring activity is based on a digital medical device with no mention of a trade or company name. The activity meets published minimum technical specifications and common prescription indications.
Consult the documentation relating to the technical specifications for the various indications defined in generic line on the page Brand name or generic line registrations: what are the differences?
The remote medical monitoring activity is based on a digital medical device that is of greater interest than conventional medical monitoring or that is equivalent to or greater than an already registered remote monitoring activity.
The interest claimed by the operator is assessed in terms of its clinical or organizational impact. If the activity corresponds to a generic line already registered, the application may be refused if it presents an interest that is only equivalent to it.
The operator's claimed interest is assessed with regard to its clinical or organizational impact.
Consult the additional documentation relating to the conditions necessary to be eligible on the page Brand name or generic line registrations: what are the differences?