Once my application has been validated, I respond to requests for additions to my file, file proofs of compliance and enter the specific requirements of the generic lines.
If any of the evidence is invalid, I am contacted by e-mail via the Convergence platform and given the opportunity to correct my digital medical device, so that it is compliant.
If I'm part of ETAPES
Following the publication of the decrees for the 4 LGs (Diabetes, Heart Failure, Renal Failure, and Respiratory Failure), I must make a complete deposit of proofs on Convergence.
Once I file my evidence, I receive a provisional certificate by ANS. This certificate is issued subject to proof compliance before 31/12/2023.
Point of attention: Once I have obtained the provisional certificate, I can already complete my request for billing code via a form on the Simplified procedures portal (I consult step 9 of the guided path). I then get a billing code by indication, within 15 days, allowing me to bill under ordinary law.
Need help?
In case of difficulty, you can contact the team in charge via the Convergence platform's internal messaging system.
08. I receive certifications
Finalisation
ANS
I obtain certificates of conformity
Once my application has been validated, I will receive my compliance certification documents by email, as well as information for the rest of the digital medical device compliance certification procedure.
I receive the following two certifications:
the interoperability and safety repository for DMNs
compliance with the minimum requirements generic lines for each of the pathologies
.
I download my complete guided tour and the checklist summarizing all the actions I need to take.