Early Access

Implementing early access to digital medical devices

What is the purpose of the action?

As of 2022, early access for digital medical devices is planned, in order to facilitate the reimbursement access mechanisms

Who is it for ?

•   Companies offering digital therapy solutions (DTx)
•   Companies offering remote monitoring solutions 

Key information

During 2022: implementation of the system


The innovation and life cycle of digital MDs is shorter and faster than non-digital MDs. The public consultation highlighted the need for clarity in the mechanisms for access to reimbursement.


The Social Security Financing Act 2022 provides for a new transitional and temporary one-year reimbursement access scheme allowing : 

  • Ensure rapid acess to innovation 
  • Require companies to provide the required data for the evaluation of their coverage 

It will be restricted, after validation of technical criteria, to digital solutions presumed to be innovative in terms of remote monitoring and digital therapies also known as "digital therapeutics" or DTx.


  • Second semester of 2022

    Launch of early access for digital medical devices