Your application is evaluated by the commission and Ministers
13. The commission evaluates your application
Application
CNEDiMTS
Your application is reviewed by the commission
If you’ve received an AR of the file from the Ministry, your application will be reviewed first by the CNEDIMTS commission.
If the documents provided do not contain all the necessary information
Delay
10 days (or more)
You’ll be notified by the HAS or by the Ministers of Health and Social Security about what additional information must be provided within a period of no less than 10 days.
If you don’t submit the requested information by the deadline, your application for eligibility will be considered void.
14. You get an opinion
Application
CNEDiMTS
You get a favourable opinion from the commission
Delay
90 - 70 days
The commission's opinion will be communicated to you within 90 days, or 70 days if the remote monitoring activity is covered by the advance payment system, and it is published on the HAS website.
You get a favourable or unfavourable opinion via the EVATECH platform.
You can provide comments
Delay
10 days
Once the draft opinion has been returned to you by the commission. You have 10 days following receipt to:
Send any written comments to the commission via the EVATECH platform, with an email copy to the Ministers at DSS-SD1C@sante.gouv.fr.
Or request a hearing before the commission.
Please note: If choosing this option, the hearing date is set within 45 days after receiving your application. Upon a reasoned request from the Ministers of Health and Social Security to the commission, this period may be reduced to one month
At the end of this phase, the opinion is communicated to you via the EVATECH platform, as well as to the CNPs and Ministers, and it is published on the HAS website.
15. Your application is evaluated
Application
MSS
Your application is evaluated by the Ministers
Once you receive the commission's opinion, your application will be reviewed by the Ministers of Health and Social Security.
If the documents provided do not contain all the necessary information
Delay
10 days (or more)
You’ll be notified by e-mail by the Ministers about what additional information must be provided within a period of no less than 10 days.
If you don’t submit the requested information by the deadline, your application for eligibility will be considered void.
16. You’ve achieved reimbursability
Finalisation
MSS
Become reimbursable under standard system
Delay
120 days
The Ministers' decision is set by order within 120 days of the acknowledgement of receipt.
If the decision is positive, the order will be published in the Official Journal. If the application is rejected, you’ll receive a letter from the Ministers.
You can reapply on the EVATECH platform without applying on the ANS website if your product has not undergone any technical changes and if the ANS standards have not changed.
Your eligibility for reimbursement under the standard system is valid for up to 5 years; how long is specified in the order in the Official Journal. If my certificate of compliance is still valid, you can apply to renew your registration directly on the EVATECH platform. Please note: The application must be submitted no later than 120 days before the expiration of the registration period.
You have completed the guide
You know all the steps
Download the entire step-by-step guide as well as the checklist summarising all the actions to be taken