Checking to see if you’re eligible for early access to reimbursement (PECAN)

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Is your DMD therapeutic or a remote monitoring activity?

What is a digital MD with therapeutic purposes?

  • Any digital MD that aims to diagnose or treat a medical condition or compensate for a disability
  • Not included are digital MDs that are related to prevention, prognosis or prediction

What is a remote monitoring solution?

It is the combination of:

  • Medical monitoring performed remotely by a medical professional or a medical team on the basis of data transmitted by the patient
  • The use by the patient of a digital medical device for remote monitoring

Learn more: see our page on remote monitoring.

Has your product earned CE marking for medical devices?

To be marketed in the EU, your DMD must meet general safety and performance requirements. They are defined in the European regulations on MDs.

Learn more: CE Marking

Can you demonstrate the clinical and/or organizational benefits of your solution?

Your DMD must have purportedly innovative features, in terms of clinical and/or organizational benefits.

The assessment of your MD’s usefulness is based on evidentiary clinical trials, whose type may differ depending on the intended service.

Here are 7 good questions to ask yourself.

 

Is your solution innovative?

You must be able to credibly argue that your solution is "innovative". It will be evaluated by the CNEDiMTS.

The solution should be purportedly innovative in terms of clinical benefits or organizational improvements. This assessment is the sole responsibility of the Commission and is based on the initial data available, taking into account any relevant comparators.

Does your MD or remote monitoring activity allow the processed data to be exported?

  • It allows data to be exported in appropriate interoperable formats or nomenclature that ensure direct access to the data.
  • Or it contains interfaces for exchanging data with devices or accessories to collect the patient's vital signs.

 

Is your solution already being covered by the Health Insurance Fund in a different way?

You’re eligible for early access to reimbursement (PECAN)

Early reimbursability is relevant to you

J'accède à ma feuille de route pour obtenir la PECAN