Registering as a brand name or generic: What are the differences?
The operator of a remote monitoring digital medical device (DMD) must apply to be included on the list of remote medical monitoring activities (the LATM list). There are currently two categories to apply in.
The two categories of applications to be included on the LATM
1. Registration as a generic
This for several types of DMDs that are characterised by common technical specifications and precise indications without mentioning a trade or company name. These generic lines are described in a ministerial order after the CNEDiMTS has issued an opinion.
2. Registration as a brand name
At the operator's request, the remote monitoring activity is based on a single DMD described by its brand or trade name. This category is required for a DMD:
- Whose indication or technical specifications do not correspond to any existing generic line
- And/or that claims a superior benefit in efficacy or organizational impact compared to other activities already covered.
Steps to getting reimbursed for your remote monitoring solution based on which type of registration you choose
If you're coming from ETAPES, you can apply for registration as a generic
- Demonstrate that you are eligible
- by obtaining an ANS certificate of compliance with the interoperability and security standards and the technical specifications
- Request an individual code from the ministers in order to get covered
- Demonstrate that you are eligible by obtaining an ANS certificate of compliance with the interoperability and security
- Present the evidence of your DMD’s benefits which will be evaluated by the CNEDiMTS
- Submit your application on the HAS EVATECH platform