As part of the certification of compliance of DMNs with the interoperability and safety standards for digital medical devices, we would like to inform you thatthe "generic line" window on convergence is open in nominal phase thanks to the publication of the generic line decrees:

• insuffisance respiratoire
• diabetes
• renal failure
• heart failure

The transitional phase of the generic online pathway for certifying digital medical devices' compliance with the repository has ended. The ANS is now in a position to validate admissibility on Convergence, issue an official and definitive opinion on the evidence submitted by ENSs and issue a certificate of conformity.

The order concerning implantable cardiac prostheses will be published at a later date. In the meantime, evidence concerning this generic line is not published in Convergence. If you are a candidate and concerned, you can move forward on the interoperability and safety requirements in nominal mode.

All DMN counters are now open in nominal mode!

Your current file is sufficient.

However, if your administrative file is not complete, you must finalize the admissibility form and submit it. Otherwise, you have no immediate action. Several steps follow:

• as soon as ANS has validated the admissibility of your DMN, you will receive the agreement to sign;
• as soon as the ANS receives the agreement signed by the ENS, the ANS will open the proof deposit area;
• you must re-file all interoperability and safety proofs by section, as well as proofs corresponding to the technical specifications of one or more generic lines that concern you (diabetes, heart failure, renal failure, respiratory failure and implantable cardiac prostheses).

If you had already submitted proofs for opinion during the transitional phase, and the ANS has issued feedback on them, please take them into account to move forward as quickly as possible in the certification process.

For more information, please feel free to consult the application guide on the ANS website.

The ANS will be able to issue the certificate of compliance with the DMN interoperability and safety reference frame, as well as the certificate of compliance with the generic description(s).

As soon as the ANS certificate has been issued,the billing code request can be made on the Simplified procedures website of the Ministry of Health and Prevention.

If you have any questions, please do not hesitate to contact the person in charge of your application via the Convergence messaging system.

As a reminder, the next deadline is December 31, 2023. The DMN certificate becomes obligatory to remain on the LPP!