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 ETAPES experiments came to an end on 1 July 2022. The switch to the standard reimbursement system is scheduled for 1 July 2023. During the transition period between the end of ETAPES and the start of the standard process, your remote monitoring activity is still being reimbursed.
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?
The remote medical monitoring activity is based on a digital medical device that is of greater benefit than conventional medical monitoring or is equivalent to or greater than the benefits of a remote monitoring activity that is already on the list.
The benefit claimed by the operator is assessed in terms of its clinical or organisational impact. If the activity corresponds to a generic that is already on the list, the request may be denied if its benefit is merely equivalent to the existing one.
Read the additional documentation on the conditions necessary to become eligible at Registering as a brand name or generic: What are the differences?